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Ridge Augmentation Using DFDBA and Cortical Cancellous Chips in a Thermoplastic Matrix (Regenaform)

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PAGE 1

RIDGE AUGMENTATION USING DFDBA AND CORTICAL CANCELLOUS CHIPS IN A THERMOPLASTIC MA TRIX (REGENAFORM™) By ANGEL R. SANTIAGO A THESIS PRESENTED TO THE GRADUATE SCHOOL OF THE UNIVERSITY OF FLOR IDA IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE UNIVERSITY OF FLORIDA 2006

PAGE 2

Copyright 2006 by Angel R Santiago, D.M.D.

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This document is dedicated to my fam ily, instructors, and fellow residents.

PAGE 4

iv ACKNOWLEDGMENTS I would like to thank all of the periodontists that c onstantly support the University of Florida Graduate Periodontics Department with their unselfish outpour of knowledge, wisdom, and patience, specifi cally, Herbert J Towle, III, D.D.S., Gregory M Horning, D.D.S., M.S., Arthur Vernino, D.D. S., and Frederic Brown, D.D.S.

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v TABLE OF CONTENTS page ACKNOWLEDGMENTS.................................................................................................iv LIST OF TABLES............................................................................................................vii LIST OF FIGURES.........................................................................................................viii ABSTRACT....................................................................................................................... ix CHAPTER 1 INTRODUCTION........................................................................................................1 2 BACKGROUND..........................................................................................................2 Graft Material...............................................................................................................3 History of Ridge Augmentation....................................................................................3 Membranes...................................................................................................................4 Healing in Bone Regeneration......................................................................................4 3 AIM OF STUDY..........................................................................................................5 4 NULL HYPOTHESIS..................................................................................................6 5 MATERIALS AND METHODS.................................................................................7 Inclusion Criteria..........................................................................................................7 Exclusion Criteria.........................................................................................................7 Sample Selection..........................................................................................................8 Custom Stents...............................................................................................................8 Surgical Technique.......................................................................................................9 Post-Operative Care....................................................................................................10 6 RESULTS...................................................................................................................14 Statistics for Percentage Graft Resorption..................................................................22 Quality of Bone...........................................................................................................25 Implant Survival.........................................................................................................26 7 DISCUSSION.............................................................................................................29

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vi APPENDIX A STATISTICAL ANALYSIS......................................................................................31 B RAW DATA...............................................................................................................35 LIST OF REFERENCES...................................................................................................36 BIOGRAPHICAL SKETCH.............................................................................................38

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vii LIST OF TABLES Table page 2-1 Requirements for Bone Regeneration a nd Surgical Procedures That Meet the Required Criteria........................................................................................................4 5-1 Siebert Classification..................................................................................................8 5-2 Distribution of s ites according to Siebert classification.............................................8 6-1 Bone Gain—RANGE...............................................................................................19 6-2 Bone Gain—AVERAGE..........................................................................................20 6-3 Resorption—RANGE...............................................................................................20 6-4 Resorption—AVERAGE.........................................................................................20 6-5 Amount Grafted—RANGE......................................................................................21 6-6 Amount Grafted—AVERAGE................................................................................21 6-7 Mean Percentage Resorption....................................................................................21 6-8 Mean and Standard Deviati on with Infected Case (IC)...........................................22 6-9 Means according to Arch with IC............................................................................23 6-10 Means according to Gender with IC........................................................................23 6-11 Means and Standard Deviation without IC..............................................................24 6-12 Means according to Arch without IC.......................................................................24 6-13 Means according to Gender without IC...................................................................24

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viii LIST OF FIGURES Figure page 5-1 Ridge prior to ridge augmentation...........................................................................11 5-2 Mucoperiosteal reflection........................................................................................11 5-3 Collection of measuremen ts using custom stent......................................................11 5-4 Cortical penetrations................................................................................................12 5-5 Graft adaptation........................................................................................................12 5-6 Collagen membrane placement................................................................................12 5-7 Tension-free closure.................................................................................................13 5-8 Temporary removable partial denture......................................................................13 5-9 Re-entry at 6 months for implant placement............................................................13 6-1 Example of case .Complete series............................................................................15 6-2 Chart demonstrating percentage of graft resorption according to site.....................22 6-3 Ridge split performed on graft at implant placement...............................................26

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ix Abstract of Thesis Presen ted to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Master of Science ONLAY RIDGE AUGMENTATION UTILIZING DFDBA AND CORTICAL CANCELLOUS CHIPS IN A THERMOPL ASTIC MATRIX (REGENAFORM™) By Angel R. Santiago May 2006 Chair: Ikramuddin Aukhill Major Department: Periodontics Background: The objectives of this study were to determine if the use of a proprietary preparation of DFDBA and cortical cancellous chips in a thermoplastic matrix (Regenaform™) for onlay ridge augmen tation procedures yields adequate volume of bone formation for implant placement. As endosseous dental implant placement is often compromised in atrophic alveolar ridges, augmentation is often required. Autogenous onlay blocks require a second su rgical site and can have significant postoperative sequelae. A tissue banked alternat ive with comparable efficacy to that of autogenous bone grafting would offer an at tractive clinical alternative. Materials and methods: Eleven patients (4 males and 7 females) with a total of 16 sites requiring a ridge augmentation procedure prior to implant placement were selected. The mean age was 59 years of age. Regenafo rm™ block grafts were used alone with placement of a resorbable collagen membrane Augmentation procedures were performed using full thickness flap reflection, cortical penetrations, graft adaptation, collagen

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x membrane adaptation, and tension free primary cl osure. Using a custom fabricated stent, measurements were taken pre-gr aft, post-graft, and at 6 mont hs to record bone gain or loss and to evaluate the effectiveness of th is material in ridge augmentation surgery. Results: The range of horizontal bone a ugmentation obtained using this graft material was 1-6 mm. Mean bone augmen tation horizontally wa s 3.66 mm (2.64mm in the maxilla and 4.28mm in the mandible). Th e range of vertical bone augmentation obtained was 0-3 mm with a mean of 0.54 mm A difference in resorption, though not statistically significant, was seen between the maxilla and mandible at the horizontal measurements (38% graft resorption for maxilla and 29% for mandible). A total of 25 implants were placed into the grafted sites and to date there have been 0 failures. Conclusion: In the present study, the principle of GBR was applied using Regenaform™ in conjunction with a resorb able collagen membrane for the purpose of placing dental implants. While previous studies report greater resorpti on of bone grafts in the maxilla as opposed to the mandible ther e was no statistical difference between these two anatomic areas in our study in this rega rd (max: 38%; man: 29%). In all cases with uneventful healing, sufficient bone regenerati on was obtained with this procedure to allow for implant placement. It was demonstrated that Regenaform™ used as an onlay graft material could minimize or eliminate the need for a donor site. This study shows that Regenaform™ in combination with a collagen membrane pr ovides a predictable method for regenerating vertical bone up to 3 mm, with a mean of 0.54 mm and up to 6 mm of bone horizontally with a mean of 3.66 mm (maxilla= 2.64 mm and mandible= 4.28 mm).

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1 CHAPTER 1 INTRODUCTION Endosseous dental implant placement is often compromised when placed in atrophic alveolar ridges. Ri dge augmentation procedures are designed to widen ridges prior to implant placement. Traditionally, onlay ridge augmentation procedures have consisted of using an autogenous block graft fr om a separate surgical area such as the ramus, chin, posterior ridge, and on occasion, the tibia, iliac crest, or ribs. This donor site can be uncomfortable to the patient and leaves a potential for post-surgical complications. The need for a donor site would be reduced if a graft material such as Regenaform™ were shown to provide adequate volume and quality of new bone in previously atrophic sites.

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2 CHAPTER 2 BACKGROUND The success and long term prognosis of endo sseous implants in the treatment of fully or partially edentulous pa tients has been well documented.1,2,3 Adequate volume and quality of bone in the edentulous area is re quired for acceptable functional and aesthetic results.4 A minimum of 5 mm of ridge widt h is required for implant placement.5 (using narrow diameter implants) When placing standa rd diameter implants, 4 mm, it has been stated that a minimum of 6 mm of ridge width is required.6,7 Insufficient bone dimensions result from excessive alve olar bone resorption that can occur following extractions, trauma, or pathosis. This may prevent plac ement of fixtures in acceptable locations, angulations, and lengths. As a result, endosseous dental implant placement is often compromised when placed in atrophic alveolar ridges. Ridge augmentation procedures are desi gned to widen ridges prior to implant placement. Various grafting procedures have been utilized for grafting an edentulous ridge, including, allograft, auto graft or xenograft with or wi thout a titanium re-enforced membrane, ridge-splits, distr action osteogenesis, and onlay grafting with an autogenous or allograft bone block. Traditionally, onl ay ridge augmentation procedures have consisted of using an autogenous block graft fr om a separate intra-oral surgical area such as the ramus, chin, posterior ridge, or from extr a-oral sites such as the tibia, iliac crest, or ribs.8,9,10,11,12 The need for a second surgical site c ould be eliminated if a graft material such as Regenaform™, were shown to provide adequate volume and quality of new bone in previously atrophic sites.

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3 Graft Material Regenaform™ was developed at the Univ ersity of Florida Tissue Bank, now known as Regeneration Technologies Inc. It is a bone paste all ograft comprised of decalcified freeze dried bone allograft (DFD BA) and 1-3mm size cortical cancellous chips in a water insoluble thermoplastic porc ine collagen gelatin carrier that resorbs in approximately 10 days. It has a rigid rubbery consistency at room and body temperature and becomes soft and moldable when warmed to 43 49 C in a heated water bath for approximately 15 minutes. The DFDBA in Regenaform™ processed bone has proven to be osteoinductive using the UristStrates model.13 Each batch is tested for osteoinductivity by implanting the DFDBA intr amuscularly in rats and checking for new bone formation. History of Ridge Augmentation The same basic principle of guided tissu e regeneration (GTR) has been used to regenerate new bone in alveolar defects.14 Nyman et al (1990) was the first to publish the enlargement of a reduced alveolar ridge.15 Siebert J, Nyman S (1990) were the first to publish a study that evaluated the potential to reconstruct localized ridge defects with bone (dog model).16 Buser, Bragger, Lang, Nyman (1990) published 9 successful cases of ridge augmentations followed by implant placement in 7 humans.17 Since then, Becker & Becker, Jovanovic, Buser et al have all documented successf ul regeneration of such of reduced ridges implementing the principles of GTR. Ri dge augmentation concepts employed the same principles of specific ti ssue exclusion seen in GTR, but were not associated with teeth. Therefore, the term applied to this procedure was guided bone regeneration (GBR).

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4 Membranes Resorbable and non-resorbable membranes have been shown to be effective in GBR procedures.18 Ridge augmentation can be predic tably accomplished provided that the membrane is properly adapted and comp lete closure is obtained throughout the healing phase.19 If the membrane becomes exposed th ere is an increased possibility of resorption and lack of continuity between the graft and host bone.20 Healing in Bone Regeneration There are three mechanisms of healing th at can take place with a bone graft. Osteogenesis is when new bone is formed from live cells (autograft). Osteoconduction occurs as a result of an inert scaffold which permits the in-g rowth of surrounding host bone. And, osteoinduction, which is the forma tion of new bone by act ive recruitment of host cells with the potential for osseous re pair. For optimal bone regeneration to take place, Lang et al established that an undisturbe d healing period of at least six months is required. There are six generally ag reed upon requirements for bone regeneration to take place and are shown in below (Table 2-1). 21 Table 2-1: Requirements for Bone Regenerati on and Surgical Procedures That Meet the Required Criteria. Biological Requirements Surgical Procedure Blood Supply Cortical perforations Stabilization Fixation screws, membranes Osteoblasts Autogenous bone graft, cortical perforations Confined space (soft tissue exclusion) Barrier membrane Space maintenance Tenting screws, Ti re-enforced membranes, bone graft materials Wound coverage Flap management, tension-free suturing

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5 CHAPTER 3 AIM OF STUDY The aim of the study was to determine volume changes of bone following ridge augmentation with Regenaform™ by conducting a clinical trial compromised of a series of augmentation surgeries to include collecti on of clinical measurements of the ridges prior to and after a six month healing. Specific objectives are listed below: 1. To clinically measure the amount of horiz ontal and vertical bone gain obtained using this bone allograft at differ ent points along the ridge. 2. To determine the: Amount of bone grafted. Amount of bone gain. Amount of graft resorption. 3. To assess the quality of bone at implan t placement following a six month healing period. 4. To compare the results obtained in the maxilla versus the mandible.

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6 CHAPTER 4 NULL HYPOTHESIS This material is effective in ridge augm entation for the purpose of future implant placement. There is a correlation between graft resorption and location of graft placement. The maxilla exhibits greater percentage of graft resorption.

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7 CHAPTER 5 MATERIALS AND METHODS Among the patients referred to the Univers ity of Florida, Graduate Periodontics clinic for implant placement, 14 patients th at required ridge augm entation procedures prior to implant therapy were included in this study. Four of these patients required multiple areas of ridge augmentation resulting in 19 surgical sites. If a patient required more than one site, they were separated by at least a single tooth and were performed at different times to allow healing of the surrounding tissues. Inclusion Criteria The following inclusion criteria were used: Partial edentulism with ridge deficiency. Both maxillary and mandibul ar arches were included. Horizontal and/or vertical deficiencies were included. Future implant treatment planned for site. Age limited to a minimum of 18 years of age. Males and females included. Exclusion Criteria The following exclusion criteria were used: Over a pack a day smokers. Diabetics (uncontrolled) or othe r severe systemic diseases. Pregnant or lactating. The need for antibiotic prophylaxis. Any other conditions contrai ndicating periodontal surgery. Unable to make all scheduled post-ops. Diagnosed with aggressive periodontitis. Patient allergic to porcine products. Patients unwilling to have porcine products used on them.

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8 Sample Selection Of the 19 surgical sites, 8 were on the maxilla and 11 on the mandible. Of the 14 patients selected, 4 were males and 7 female s. Only one patient reported smoking. It was in the form of 2-3 cigars per week. Ages range from 26-77 years of age with a mean age of 56. Two females (equaling 5 sites) report ed taking oral bisphosphonates for osteoporosis for over a 2 year period. The sites were classified using the Si ebert classification of ridge defects. 22 Table 5-1. Siebert Classification Classification of Site Description of Loss I Buccolingual with normal ridge height II Ap icocoronal with normal ridge width III Buccolingual and apicocoronal Table 5-2. Distribution of sites ac cording to Siebert classification Classification of Site # sites in each class I 6 II 0 III 13 Custom Stents Alginate impressions were taken prior to surgery and diagnostic casts were poured in microstone. Triad™ acrylic was used to “build up” the ridge on the casts and allow room for graft material unde rneath the stent. Measurements were collected using a custom fabricated stent. 1.0 mm thick vacu form plastic sleeves were used to make custom stent. A hole was created in the stents directly over the ri dge in the area of greatest deficiency and was designated the Ve rtical point. The Horizontal points were created through the faci al of the stents in a coronoapical direction at: 4 mm & 8 mm apical to the alveolar crest. These holes co rrelated to the area of greatest horizontal

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9 deficiency. Holes were created using a 169L bur. Measurements were then taken using a UNC15 probe placed through the holes created in the stent. The probe was maintained as close to perpendicular to the stent as possibl e. Measurements were taken three times at each site: (1)after flap reflection but before graft placement, (2) after graft placement, & (3) at 5-7 month re-entry for implant placement. Surgical Technique The surgical procedures were carried out by two of the authors (A.S. & D.D). All surgeries were performed under local anesthes ia. Crestal incisions were made to the lingual/palatal of the ridge while still in ke ratinized gingiva with divergent vertical incisions only performed when needed to rel ease tension on the flaps. Full thickness flaps were reflected (Figure 2). Af ter flap reflection, a UNC15 mm probe was used to record measurements, to the nearest millimeter, through the holes created in the stent, 1 vertical point and 2 horizontal points (Figure 3). Th e cortical bone was perforated using a #2 round bur on high speed handpiece. Depth of penetration was extended only through the cortical plate (Figure 4). Decortication is performed to allow angioneogenesis into the grafted site. A 0.5, 1, or 2 cc block was selected dependi ng on number of implants desired and size of augmentation required. Following cort ical penetrations, the graft material was then placed in a water bath and heated be tween 43 49 C for 10-15 minutes. The graft was removed from the water bath once it b ecame depressible to the touch. The graft material was then molded and adapted to the defect (Figure 5). Once cooled to room temperature, the graft material became solid allowing it to maintain the shape of the defect and/or desired augmentation. Using the same stent, the measurements were taken after graft placement, 1 vertical and 2 horiz ontal (4 & 8 mm). Type I bovine collagen

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10 resorbable membranes were used for graft st abilization and soft ti ssue exclusion (Figure 6). Two different brands of membranes we re used; BioMend Extend and Ace. One site had an Ace collagen membrane us ed. The remaining 18 had BioMend Extend membranes used. Prior to suturing, periosteal releasing incisions were performed until the flap passively covered the grafted site. Tensi on free primary closure of the surgical site was obtained (Figure 7). Suturing was comple ted using interrupted and mattress vicryl sutures. Temporary removable partial dentures were adjusted until there was no contact with the grafted area (Figure 8). Patients were asked to use the RPD as seldom as possible. Post-Operative Care Post-operative antibiotics prescribed we re: Augmentin 500 mg TID or Clindamycin 300 mg 1q6h for the first week of healing. Pa tients were instructed not to chew on the area for approximately 2 weeks. Chlorhexidin e (0.12%) rinse twice a day was instituted for the first week. Patients were prescribed 600-800 mg of ibuprof en 1q6-8h for the first 3 days to help minimize swelling of the area. Analgesics were prescribed when needed. Patients were seen for suture removal at 10-14 days. Further recall appointments were scheduled at 1 month, 3 month, 5 month, & 6 months. At the 5 month recall, a panoral radiograph was taken and impressions were obtained. These were used to fabricate a surgical guide for implant placement. At 5-7 months the sites were re-entered (Figure 9). The ridge was measured at the same points usi ng the same custom stent as at the time of graft surgery. Afterwards, implants were pl aced using one of the available implant systems (3i Innovations™, Straumann™, As tra Tech™, or Nobel Biocare™).

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11 Figure 5-1. Ridge prior to ridge augmentation Figure 5-2. Mucoperiosteal reflection Figure 5-3. Collection of measur ements using custom stent

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12 Figure 5-4. Cortical penetrations Figure 5-5. Graft adaptation Figure 5-6. Collagen membrane placement

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13 Figure 5-7. Tension-free closure Figure 5-8. This figure shows an example of a temporary removable partial denture. Temporary RPDs were only made for Max anterior cases. Figure 5-9. Re-entry at 6 m onths for implant placement

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14 CHAPTER 6 RESULTS Of the 14 patients that entered the study, 11 (4 males and 7 females) returned for implant placement. One patient was dropped fr om the study due to inability to re-enter within the 5-7 month period. One patient moved out the area. And, one patient dropped out due to changes in their finances that did not allow implant placement. From the 11 returning patients, there were a total of 16 augmented sites. Ages range from 43-77 years of age with a mean age of 59. Two patients experienced membrane exposur e, one of these patients experienced a post-operative infection evident by pus flow from the vertical releasing incision. The patient was seen at the 1st recall and given another week of antibiotics. This time, clindamycin was prescribed. The infection was not clinically present by the 1 month recall and the graft did not have to be re moved. Subsequent implant placement was not possible at re-entry due to excessive resorption and the si te was grafted a second time. This site will be referred to as IC (infect ed case) for the rest of this presentation. The other patient experienced a la rger membrane exposure that was managed by instructing patient to saturate the exposed area with ch lorhexidine 3 times per day. By the first month recall, the site had closed and th e membrane was no longer visible. The results will be discussed in terms of amount bone gain (regeneration), amount of graft resorption, amount gr afted, % of graft resorption, quality of bone, and implant survival.

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15 Figures 6-1. Example of an experimental case Complete series. (a) Multiple tooth site #22-26. (b) Crestal incision with vertical releasing incisions #21 distal and #27 distal. (c) Cortical perforations. (d) Adaptation of graft material to defect and desired augmentation. (e) Resorbable collagen membrane trimmed to fit over graft site. (f) Tension free primary closure using mattress and interrupted sutures. (g) Graft site after 6 mont h healing. (h) Six month re-entry for implant placement. (i) Implant placemen t. (j) Radiograph taken 2 months post implant placement. (a) (b)

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16 (c) (d)

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17 (e) (f) (g)

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18 (h) (i) (j)

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19 Table 6-1.Bone Gain—RANGE Measurement point Max or Mand (n) Range (mm) Vertical Point Max(6) 0-1 Mand(7) 0-3 Max & Mand(13) 0-3 Horizontal 4mm point Max(6) 2-3 Mand(10) 1-6 Max & Mand(16) 1-6 w/o IC= 3-6 Horizontal 8mm point Max(5) 2-4 Mand(10) 3-6 Max & Mand(15) 2-6 Total horiz. (4&8 mm) Max(11) 2-4 Mand(20) 1-6 Max & Mand(31) 1-6 w/o IC= 1-6

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20 Table 6-2.Bone Gain—AVERAGE Measurement point Max or Mand (n) Average (mm) Vertical Point Max(6) 0.33 Mand(7) 0.83 Max & Mand(13) 0.54 Horizontal 4mm point Max(6) 2.2 Mand(10) 4.0 w/o IC= 4.3 Max & Mand(16) 3.3 w/o IC= 3.5 Horizontal 8mm point Max(5) 3.2 Mand(10) 4.1 w/o IC= 4.2 Max & Mand(15) 3.8 w/o IC= 3.9 Total horiz. (4&8 mm) Max(11) 2.6 Mand(20) 4.1 w/o IC= 4.3 Max & Mand(31) 3.6 w/o IC= 3.7 Table 6-3. Resorption—RANGE Measurement point Max or Mand (n) Average (mm) Vertical Point Max(6) 0-4 Mand(7) 1-4 Max & Mand(13) 0-4 Horizontal 4mm point Max(6) 0-3 Mand(10) 1-4 w/o IC=1-4 Max & Mand(16) 0-4 Horizontal 8mm point Max(5) 0-4 Mand(10) 0-3 w/o IC= 0-3 Max & Mand(15) 0-4 Total horiz. (4&8 mm) Max(11) 0-4 Mand(20) 0-4 w/o IC=0-4 Max & Mand(31) 0-4 w/o IC= 0-4 Table 6-4 Resorption—AVERAGE Measurement point Max or Mand (n) Average (mm) Vertical Point Max(6) 2.0 Mand(7) 1.6 Max & Mand(13) 1.8 Horizontal 4mm point Max(6) 2.0 Mand(10) 2.0 w/o IC=1.89 Max & Mand(16) 2.0 w/o IC=1.93 Horizontal 8mm point Max(5) 1.2 Mand(10) 1.40 w/o IC= 1.44 Max & Mand(15) 1.33 w/o IC= 1.36 Total horiz. (4&8 mm) Max(11) 1.6 Mand(20) 1.7 w/o IC= 1.7 Max & Mand(31) 1.7 w/o IC= 1.7

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21 Table 6-5 Amount Grafted—RANGE Measurement point Max or Mand (n) RANGE (mm) Vertical Point Max(6) 1-4 Mand(7) 1-4 Max & Mand(13) 1-4 Horizontal 4mm point Max(6) 3-5 Mand(10) 4-8 Max & Mand(16) 3-8 Horizontal 8mm point Max(5) 4-8 Mand(10) 3-4 Max & Mand(15) 4-8 Total horiz. (4 & 8 mm) Max(11) 3-5 Mand(20) 4-8 Max & Mand(31) 3-8 Table 6-6 Amount Grafted—AVERAGE Measurement point Max or Mand (n) Average (mm) Vertical Point Max(6) 2.0 Mand(7) 2.3 Max & Mand(13) 2.15 Horizontal 4mm point Max(6) 3.8 Mand(10) 6.0 Max & Mand(16) 5.2 Horizontal 8mm point Max(5) 4.2 Mand(10) 5.5 Max & Mand(15) 5.1 Total horiz. (4&8 mm) Max(11) 4.0 Mand(20) 5.8 Max & Mand(31) 5.1 Table 6-7 Mean Percentage Resorption Measurement point Max or Mand (n) % Resorption Vertical Point Max(6) 58% Mand(7) 81% Max & Mand(13) 70% Horizontal 4mm point Max(6) 45% Mand(10) 34% w/o IC= 29% Max & Mand(16) 38% w/o IC= 36% Horizontal 8mm point Max(5) 26% Mand(10) 24% w/o IC= 23% Max & Mand(15) 24% w/o IC= 24% Total horiz. (4 & 8 mm) Max(11) 38% Mand(20) 29%w/o IC=27% Max & Mand(31) 32%w/o IC=31%

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22 0 10 20 30 40 50 60 70 80 90 Maxilla/MandibleMandible Vertical Horizontal 4 mm point Horizontal 8 mm point Horizontal total (4 & 8 mm points) Figure 6-2 Percentage of graf t resorption. Infected case (I C) was excluded from this chart. Statistics for Percentage Graft Resorption The following slides will show the mean, standard deviation, minimum, maximum, and median percentage graft resorption fo r whole group, by sites and by gender groups. With and without the IC (infected case). Table 6-8 Mean and Standard Devi ation with Infected Case (IC) with IC The MEANS Procedure Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 13 70.461538539.331106 0 100 100 resorpH4_p 16 38.0625 19.78035640 75 39 resorpH8_p 15 24.333333320.74906770 80 25 resorpH4H8_p 16 32.4375 17.15019440 70 33

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23 Table 6-9.Means according to Arch with IC with IC The MEANS Procedure site=L Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 7 80.8571429628.404392725 100 100 resorpH4_p 10 33.9 17.816658917 75 27 resorpH8_p 10 23.5 13.89044440 43 25 resorpH4H8_p 10 29.2 12.09040029 50 29 site=U Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 6 58.3333333 49.159604 0 100 75 resorpH4_p 6 45 22.58317960 60 50 resorpH8_p 5 26 32.67261850 80 25 resorpH4H8_p 6 37.8333333 23.73534640 70 41 No statistically significant differe nce between Upper and Lower arches. Table 6-10.Means according to Gender with IC with IC The MEANS Procedure gender=f Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 9 66.666666745.06939090 100 100 resorpH4_p 12 39.083333319.350632317 75 33.5 resorpH8_p 12 28.333333320.56180630 80 25 resorpH4H8_p 12 34.25 16.39359639 70 33 gender=m Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 4 79 25.113077650 100 83 resorpH4_p 4 35 23.80476140 50 45 resorpH8_p 3 8.3333333 14.43375670 25 0 resorpH4H8_p 4 27 20.800641 0 50 29 No statistically significant difference in % of graft resorption between genders.

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24 Table 6-11 Means and Standa rd Deviation without IC without IC The MEANS Procedure Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 13 70.461538539.331106 0 100 100 resorpH4_p 15 35.6 17.75548210 60 38 resorpH8_p 14 24.285714321.53147450 80 25 resorpH4H8_p 15 31.266666717.07741480 70 33 Table 6-12.Means according to Arch without IC without IC The MEANS Procedure site=L Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 7 80.857142928.40439270 100 100 resorpH4_p 9 29.333333311.067971817 50 25 resorpH8_p 9 23.333333314.72243190 43 25 resorpH4H8_p 9 26.888888910.21572869 44 25 site=U Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 6 58.333333349.159604 0 100 75 resorpH4_p 6 45 22.58317960 60 50 resorpH8_p 5 26 32.67261850 80 25 resorpH4H8_p 6 37.833333323.73534640 70 41 No statistically significant difference in % of graft resorption be tween upper and lower arch. Table 6-13.Means according to Gender without IC without IC The MEANS Procedure gender=f Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 9 66.666666745.06939090 100 100 resorpH4_p 11 35.818181816.467047 17 60 29 resorpH8_p 11 28.636363621.53728270 80 25 resorpH4H8_p 11 32.818181816.38791139 70 33

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25 Table6-13 continued gender=m Variable N Mean Std Dev Minimum Maximum Median ResorpV_p 4 79 25.1130776 50 100 83 resorpH4_p 4 35 23.8047614 0 50 45 resorpH8_p 3 8.3333333 14.4337567 0 25 0 resorpH4H8_p 4 27 20.800641 0 50 29 No statistically significant difference in % of graft resorption between genders. Sites group and gender group were compar ed using parametric T-test and nonparametric Wilcoxon Rank Sum test (becau se of small sample size and non-normal distribution). There is no st atistically significant difference in % resorption between Maxillary and Mandibular gr oups, and between Female and Male groups. Also, performed was two -way ANOVA (one factor is sites and the other factor is gender) using the raw percent change (parametric way) and using ranks (nonparametric way, again because of small sample size and nonnormal distribution). Sites and gender both have no significant effects on the percent changes. Finally, the interaction between sites and gender was also tested in the two-wa y ANOVA models. There was no statistical significance. Quality of Bone The two surgeons were asked to classify the type of bone encountered at implant placement using the Misch bone density classification. Misch Bone density classification: D1, similar to drilling into oak D2, similar to pine D3, similar to balsa D4, similar to Styrofoam Distribution of bone the different bone densities encountered: D1: 3 cases (1 upper, 2 lower) D2: 11 (5 upper, 6 lower) D3: 2 (2 upper) D4: 0 were classified as D4

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26 Implant Survival A total of 25 implants(3i Innovati ons™, Straumann™, Astra Tech™, & Nobel Biocare™) were placed. Of the implants placed, their diameters were: 1 narrow diameter, 3 wide diameter, and 21 standard di ameter. To this date none of the implants paced have failed. 11 have final restorations the oldest being restored 16 months ago. There were no buccal plate dehiscences at time of placement. Two ridge splits with simultaneous implant placement were performed in maxillary anterior cases to further augment the sites (Figure 10). Figure 6-3 Ridge split performed on graft at implant placement. (a) Ridge split procedure was performed on grafted bone at the #10 site. This was an area of membrane exposure during the graft healing. (b) #10 implant placed at site of ridge split procedure. (c) Implant placement. (d) Radiograph of implant placement.

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27 (a) (b) (c)

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28 (d)

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29 CHAPTER 7 DISCUSSION Although this graft material is widely use d, to this date there has never been a documented clinical trial study performed using th is material to show its clinical efficacy. In the present study, the principle of GBR was applied using demineralized cortical cancellous chips in a thermoplastic matrix in conjunction with a resorbable collagen membrane for the purpose of placing dent al implants. There was greater resorption observed in the grafts placed in the maxilla than in the mandible. This has been documented by others i.e. Adell et al, te n Bruggenkate CM, et al. 23,24 It has been speculated that the increase blood supply offe red in the maxilla may contribute to the increases seen in graft resorption. Though ve rtical resorption ma y have been limited using tenting devices, no such devices were us ed in this study in order to limit variables and evaluate the raw potential of this graft material. No statistically significant difference was observed between the maxilla and mandibl e. In all cases with uneventful healing, sufficient bone regeneration was obtained w ith this procedure to allow for implant placement. Unlike autogenous block graft materials, this graft material was able to withstand ridge splitting procedures at time of impl ant placement without consequence. It was demonstrated that DFDBA and cortical cancellous chips in a thermoplastic matrix used as an onlay graft material could minimize or e liminate the need for a donor site. This study shows that when used alone this graft material provides a predictable method for

PAGE 40

30 regenerating vertical bone up to 3 mm, with a mean of 0.54 mm and up to 6 mm of bone horizontally with a mean of 3.66 mm (maxilla= 2.64 mm and mandible= 4.28 mm).

PAGE 41

31 APPENDIX A STATISTICAL ANALYSIS BY SITE The TTEST Procedure T-Tests Variable Method Variances DF t Value Pvalue Resorpv_p Pooled Equal 11 1.03 0.3242 resorpH4_p Pooled Equal 14 -1.09 0.2925 resorpH8_p Satterthwaite Unequal 4.74 -0.16 0.8766 resorpH4H8_p Pooled Equal 14 -0.97 0.3470 Equality of Variances Variable Method Num DF Den DF F Value Pr > F Resorpv_p Folded F 5 6 3.00 0.2142 resorpH4_p Folded F 5 9 1.61 0.5052 resorpH8_p Folded F 4 9 5.53 0.0315 resorpH4H8_p Folded F 5 9 3.85 0.0764 BY gender The TTEST Procedure T-Tests Variable Method Variances DF t Value pvalue Resorpv_p Pooled Equal 11 -0.51 0.6233 resorpH4_p Pooled Equal 14 0.35 0.7338 resorpH8_p Pooled Equal 13 1.57 0.1406 resorpH4H8_p Pooled Equal 14 0.72 0.4832 Equality of Variances Variable Method Num DF Den DF F Value Pr > F Resorpv_p Folded F 8 3 3.22 0.3651

PAGE 42

32 resorpH4_p Folded F 3 11 1.51 0.5311 resorpH8_p Folded F 11 2 2.03 0.7524 resorpH4H8_p Folded F 3 11 1.61 0.4866 by site 5 13:32 Sunday, March 19, 2006 The NPAR1WAY Procedure Wilcoxon Scores (Rank Sums) for Variable Resorpv_p Classified by Variable site Two-Sided Pr > |Z| pvalue= 0.4973 Wilcoxon Scores (Rank Sums) for Variable resorpH4_p Classified by Variable site Two-Sided Pr > |Z| | pvalue= 0.1750 Wilcoxon Scores (Rank Sums) for Variable resorpH8_p Classified by Variable site Two-Sided Pr > |Z| | pvalue= 0.6551 Wilcoxon Scores (Rank Sums) for Variable resorpH4H8_p Classified by Variable site Two-Sided Pr > |Z| | pvalue= 0.3157 By gender 9 Wilcoxon Scores (Rank Sums) for Variable Resorpv_p Classified by Variable gender Two-Sided Pr > |Z| pvalue= 0.9344 Wilcoxon Scores (Rank Sums) for Variable resorpH4_p Classified by Variable gender Two-Sided Pr > |Z| pvalue= 0.9520 Wilcoxon Scores (Rank Sums) for Variable resorpH8_p Classified by Variable gender Two-Sided Pr > |Z| pvalue= 0.1289 Wilcoxon Scores (Rank Sums) for Variable resorpH4H8_p Classified by Variable gender Two-Sided Pr > |Z| pvalue= 0.7191 The TTEST Procedure By site

PAGE 43

33 T-Tests Variable Method Variances DF t Value Pr > |t| Resorpv_p Pooled Equal 11 1.03 0.3242 resorpH4_p Pooled Equal 13 -1.80 0.0945 resorpH8_p Pooled Equal 12 -0.21 0.8343 resorpH4H8_p Satterthwaite Unequal 6.25 -1.07 0.3260 Equality of Variances Variable Method Num DF Den DF F Value Pr > F Resorpv_p Folded F 5 6 3.00 0.2142 resorpH4_p Folded F 5 8 4.16 0.0736 resorpH8_p Folded F 4 8 4.93 0.0535 resorpH4H8_p Folded F 5 8 5.40 0.0364 The TTEST Procedure By gender T-Tests Variable Method Variances DF t Value Pr > |t| Resorpv_p Pooled Equal 11 -0.51 0.6233 resorpH4_p Pooled Equal 13 0.08 0.9405 resorpH8_p Pooled Equal 12 1.52 0.1547 resorpH4H8_p Pooled Equal 13 0.57 0.5789 Equality of Variances Variable Method Num DF Den DF F Value Pr > F Resorpv_p Folded F 8 3 3.22 0.3651 resorpH4_p Folded F 3 10 2.09 0.3305 resorpH8_p Folded F 10 2 2.23 0.6991 resorpH4H8_p Folded F 3 10 1.61 0.4964 Wilcoxon Scores (Rank Sums) for Variable Resorpv_p Classified by Variable site Two-Sided Pr > |Z| 0.4973 Wilcoxon Scores (Rank Sums) for Variable resorpH4_p Classified by Variable site Two-Sided Pr > |Z| 0.0771 Wilcoxon Scores (Rank Sums) for Variable resorpH8_p Classified by Variable site Two-Sided Pr > |Z| 0.6804 Wilcoxon Scores (Rank Sums) for Variable resorpH4H8_p Classified by Variable site Two-Sided Pr > |Z| 0.2123

PAGE 44

34 Wilcoxon Scores (Rank Sums) for Variable Resorpv_p Classified by Variable gender Two-Sided Pr > |Z| 0.9344 Wilcoxon Scores (Rank Sums) for Variable resorpH4_p Classified by Variable gender Two-Sided Pr > |Z| 0.9483 Wilcoxon Scores (Rank Sums) for Variable resorpH8_p Classified by Variable gender Two-Sided Pr > |Z| 0.1432 Wilcoxon Scores (Rank Sums) for Variable resorpH4H8_p Classified by Variable gender Two-Sided Pr > |Z| 0.8463

PAGE 45

35 APPENDIX B RAW DATA patientsitegenderGrafted VResorption V%Resorption Vgrafted H4resorption H4%resorp H4grafted H8resorp H8%resorp H8grafted H4&H8r esorp H4&H8%resorp H4&H8 RWLm3266524041259333 AJ-1Uf22100536041259444 AJ-2Lf41258225822516425 AJ-3Lf11100412541258225 LRLf00061175001119 DH-1Lf0008450833816744 DH-2Lf221005120734312433 DBUm215042504008225 DD-1Lf4375512041259222 DD-2Lf111008338722915533 PCUf1105360548010770 JRUm221004250nanana4250 AS-1Lf11100722940011218 AS-2 IC Lf000437541258450 AHUf100425041258338 DMUm44100300400700

PAGE 46

36 LIST OF REFERENCES 1. Adell R, Lekholm U, Rockler B, Branemark PI. A15 year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg 1981;10:387-416. 2. Albrektsson T. A multicenter report on osse ointegrated oral implants. J Prosthet Dent 1988;60:75-84. 3. Branemark PI, Zarb GA, Albrektsson T. Tissue-integrated Prostheses: Osseointegration in Clin ical Dentistry. Chicago: Quintessencc Publ Co,1985. 4. Misch CE. Premaxilla implant considerations: surgery and fixed prosthodontics. In: Misch CE, ed. Contemporary Implant Den tistry. St. Louis, MO: Mosby Year Book 1993:427-431, 575-597. 5. Lekholm U, Adell R, Lindhe J, et al. Marg inal tissue reactions at osseointegrated titanium fixtures. II: A crosssectional retr ospective study. Intern ational Journal of Oral and Maxillofacial Surgery 1986;15:53-61. 6. Javanovic, Sascha A. Clinical Aspects of Dental Implants. Carranza’s Clinical Periodontology. 9 ed. Philadelphia: W.B. Saunders Company, 2002:889-896. 7. Lekholm U, Zarb GA. Patient selection a nd preparation, in Branemark PI, Zarb GA, Albrektsson T. (eds): Tissue-integrated prostheses: osseoint egration in Clinical Dentistry. Chicago: Quintessence Publ Co, 1985:199-209. 8. Clavero J, Lundgren S. Ramus or chin gr afts for maxillary sinus inlay and local onlay augmentation: comparison of donor si te morbidity and complications. Clin Implant Dent Relat Res 2003;5:154-60. 9. Jakse N, Seibert FJ, Lorenzoni M, Eskici A, Pertl C. A modified technique of harvesting tibial cancellous bone and its use for sinus grafting. Clin Oral Implants Res 2001;12:488-94. 10. Kondell PA, Nordenram A, Moberg LE, Elia sson S, Nyberg B. Reconstruction of the resorbed edentulous maxilla using autogenous rib grafts and osseointegrated implants. Clin Oral Implants Res 1996;7:286-90. 11. Reinert S, Konig S, Bremerich A, Eufinger H, Krimmel M. Stability of bone grafting and placement of implants in the severely atrophic maxilla. Br J Oral Maxillofac Surg 2003;41:249-55.

PAGE 47

37 12. Sandor GK, Rittenberg BN, Clokie CM, Caminiti MF. Clinical success in harvesting autogenous bone using a minimally invasive trephine. J Oral Maxillofac Surg 2003;61:164-8. 13. Urist MR: Bone formation by autoinduction. Sceince 1965;150:893. 14. Dahlin C, Linde A, Gottlow J: H ealing of bone defects by guided tissue regeneration. Plast Reco nstr Surg 1988; 81:672. 15. Nyman S, Lang NP, Buser D, Bragger U. B one regeneration adjacent to titanium dental implants using guided tissue regeneration: a repor t of two cases. Int J Oral Maxillofac Implants 1990;5:9-14. 16. Siebert J, Nyman S. Localized ridge augmentation in dogs: a pilot study using membranes and hydroxyapatite. J Periodontol 1990;61:157-65. 17. Buser D, Bragger U, Lang NP, Nyman S. Regeneration and enlargement of jaw bone using guided tissue regeneration Clin Oral Implants Res 1990;1:22-32. 18. Simion M. Guided bone regeneration us ing resorbable and non-resorbable membranes: A comparative histology in humans. Int J Oral Maxillofac Imp 1996;11:735-742. 19. Donos N, Kostopoulos L, Karring T. Al veolar ridge augmentation using a resorbable copolymer membrane and au togenous bone grafts. An experimental study in the rat. Clin Oral Implants Res 2002;13:203-13. 20. Cordaro L, Amade DS, Cordaro M. Clinical results of alveolar ridge augmentation with mandibular block bone grafts in partia lly edentulous patients prior to implant placement. Clin Oral Implants Res 2002;13:103-11. 21. Newman, Takei, Carranza. Carranza’s Clin ical Periodontology. 9ed. Philadelphia: W.B. Saunders Company 2002:71:905-921 22. Siebert JS, Cohen DW. Periodontal consider ations in preparation for fixed and removable prosthodontics. Dent Clin North AM 1987;31:529. 23. Adell R, Lekholm U, Grondahl K, Branem ark PI, Lindstrom J, Jacobsson M. Reconstruction of severely resorbed edentulous maxillae using osseointegrated fixtures in immediate aut ogenous bone grafts. Int J Oral Maxillofac Implants 1990;5:233-246. 24. ten Bruggenkate CM, Kraaijenhagen HA, van der Kwast WAM: Autogenous maxillary bone grafts in conjunction with placement of ITI endosseous implants. A preliminary report. Int J Or al Maxillofac Surg 1992; 21:81.

PAGE 48

38 BIOGRAPHICAL SKETCH Dr. Angel R Santiago attended the University of Central Florida where he studied molecular biology and microbiology. He gradua ted from Nova Southeastern University, College of Dental Medicine, in May 2003. At this time Ange l Santiago is attending the University of Florida where he is completing his post-graduate residency in periodontics.


Permanent Link: http://ufdc.ufl.edu/UFE0014310/00001

Material Information

Title: Ridge Augmentation Using DFDBA and Cortical Cancellous Chips in a Thermoplastic Matrix (Regenaform)
Physical Description: Mixed Material
Copyright Date: 2008

Record Information

Source Institution: University of Florida
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution and holding location.
System ID: UFE0014310:00001

Permanent Link: http://ufdc.ufl.edu/UFE0014310/00001

Material Information

Title: Ridge Augmentation Using DFDBA and Cortical Cancellous Chips in a Thermoplastic Matrix (Regenaform)
Physical Description: Mixed Material
Copyright Date: 2008

Record Information

Source Institution: University of Florida
Holding Location: University of Florida
Rights Management: All rights reserved by the source institution and holding location.
System ID: UFE0014310:00001


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RIDGE AUGMENTATION USING DFDBA AND CORTICAL CANCELLOUS CHIPS
IN A THERMOPLASTIC MATRIX (REGENAFORMTM)















By

ANGEL R. SANTIAGO


A THESIS PRESENTED TO THE GRADUATE SCHOOL
OF THE UNIVERSITY OF FLORIDA IN PARTIAL FULFILLMENT
OF THE REQUIREMENTS FOR THE DEGREE OF
MASTER OF SCIENCE

UNIVERSITY OF FLORIDA


2006

































Copyright 2006

by

Angel R Santiago, D.M.D.

































This document is dedicated to my family, instructors, and fellow residents.















ACKNOWLEDGMENTS

I would like to thank all of the periodontists that constantly support the University

of Florida Graduate Periodontics Department with their unselfish outpour of knowledge,

wisdom, and patience, specifically, Herbert J Towle, III, D.D.S., Gregory M Homing,

D.D.S., M.S., Arthur Vemino, D.D.S., and Frederic Brown, D.D.S.
















TABLE OF CONTENTS

page

A C K N O W L E D G M E N T S ................................................................................................. iv

LIST OF TABLES .............. ................................................ vii

LIST OF FIGU RE S ........ ........ ........................................ .. ................. viii

ABSTRACT .............. .......................................... ix

CHAPTER

1 IN TR O D U C TIO N ......................................................................... .... .. ........

2 B A C K G R O U N D .................... .... ................................ ...... ........ ...............

G raft M material ................................................................. 3
H history of Ridge A ugm entation........................................................... ............... 3
M em branes ...............................................................4
H dealing in B one R egeneration............................................................. ............... 4

3 A IM OF STU D Y ............... ........................ ........... ................ .......5

4 N U L L H Y P O TH E SIS .................................................................. ........................ 6

5 M A TERIALS AND M ETH OD S ............................................ ........................... 7

In clu sion C criteria ....................................................... 7
E xclu sion C criteria .............................................................................. ...7
Sam ple Selection ....................................................... 8
Custom Stents ...................................................................... .. ........ 8
Surgical Technique ............................................................... 9
P ost-O perativ e C are ................................................................ .... ............... 10

6 RESULTS ................................... .................................. ........... 14

Statistics for Percentage Graft Resorption................................. ....................... 22
Q quality of B one ................................................... ................ 25
Im p lant Su rv iv al ..................................................... ................ 2 6

7 DISCUSSION .................. .................................... ...........................29


v









APPENDIX

A STA TISTIC A L A N A L Y SIS ............................................................. ....................31

B R A W D A TA ...................................... ............................... ................. 35

L IST O F R E FE R E N C E S ............................................................................. .............. 36

B IO G R A PH IC A L SK E T C H ...................................................................... ..................38
















LIST OF TABLES

Table p

2-1 Requirements for Bone Regeneration and Surgical Procedures That Meet the
Required Criteria. ....................... ................ ...... ... ............... ....

5-1 Siebert Classification...................................8

5-2 Distribution of sites according to Siebert classification................... ..............8

6-1 B one G ain-- R AN GE .......................................................................... ............... 19

6-2 Bone Gain- AVERAGE...................... .......................................... 20

6-3 R esorption- R A N G E .............................................................................. ........ 20

6-4 R esorption- A V E R A G E .............................................................. .....................20

6-5 Amount Grafted-RANGE ............ ..... ................................. 21

6-6 Am ount Grafted- AVERAGE ........................................ .......................... 21

6-7 M ean Percentage R esorption......................................................... ............... 21

6-8 Mean and Standard Deviation with Infected Case (IC) .......................................22

6-9 M eans according to Arch w ith IC ........................................ ........................ 23

6-10 M eans according to Gender with IC ............................................. ............... 23

6-11 M eans and Standard Deviation without IC ................................... .................24

6-12 M eans according to Arch without IC ............................................ ............... 24

6-13 M means according to Gender without IC ....................................... ............... 24
















LIST OF FIGURES

Figure page

5-1 Ridge prior to ridge augm entation .................................. ............................ .......... 11

5-2 M ucoperiosteal reflection .......................................................................... .... 11

5-3 Collection of measurements using custom stent ...................................................11

5-4 C ortical p en etration s ....................................................................... ...................12

5-5 G raft adaptation ......... .................................................................. ......... ....... 12

5-6 Collagen m em brane place ent ..................................................... ...... ......... 12

5-7 Tension-free closure ................................................. ......................... 13

5-8 Tem porary rem ovable partial denture............................................... ............... 13

5-9 Re-entry at 6 months for implant placement...........................................................13

6-1 Exam ple of case .C om plete series................................................. .....................15

6-2 Chart demonstrating percentage of graft resorption according to site.. ..................22

6-3 Ridge split performed on graft at implant placement............... ...............26















Abstract of Thesis Presented to the Graduate School
of the University of Florida in Partial Fulfillment of the
Requirements for the Degree of Master of Science

ONLY RIDGE AUGMENTATION UTILIZING DFDBA AND CORTICAL
CANCELLOUS CHIPS IN A THERMOPLASTIC MATRIX (REGENAFORMTM)

By

Angel R. Santiago

May 2006

Chair: Ikramuddin Aukhill
Major Department: Periodontics

Background: The objectives of this study were to determine if the use of a

proprietary preparation of DFDBA and cortical cancellous chips in a thermoplastic

matrix (RegenaformTM) for only ridge augmentation procedures yields adequate volume

of bone formation for implant placement. As endosseous dental implant placement is

often compromised in atrophic alveolar ridges, augmentation is often required.

Autogenous only blocks require a second surgical site and can have significant

postoperative sequelae. A tissue banked alternative with comparable efficacy to that of

autogenous bone grafting would offer an attractive clinical alternative.

Materials and methods: Eleven patients (4 males and 7 females) with a total of 16

sites requiring a ridge augmentation procedure prior to implant placement were selected.

The mean age was 59 years of age. RegenaformTM block grafts were used alone with

placement of a resorbable collagen membrane. Augmentation procedures were performed

using full thickness flap reflection, cortical penetrations, graft adaptation, collagen









membrane adaptation, and tension free primary closure. Using a custom fabricated stent,

measurements were taken pre-graft, post-graft, and at 6 months to record bone gain or

loss and to evaluate the effectiveness of this material in ridge augmentation surgery.

Results: The range of horizontal bone augmentation obtained using this graft

material was 1-6 mm. Mean bone augmentation horizontally was 3.66 mm (2.64mm in

the maxilla and 4.28mm in the mandible). The range of vertical bone augmentation

obtained was 0-3 mm with a mean of 0.54 mm. A difference in resorption, though not

statistically significant, was seen between the maxilla and mandible at the horizontal

measurements (38% graft resorption for maxilla and 29% for mandible). A total of 25

implants were placed into the grafted sites and to date there have been 0 failures.

Conclusion: In the present study, the principle of GBR was applied using

RegenaformTM in conjunction with a resorbable collagen membrane for the purpose of

placing dental implants. While previous studies report greater resorption of bone grafts in

the maxilla as opposed to the mandible there was no statistical difference between these

two anatomic areas in our study in this regard (max: 38%; man: 29%). In all cases with

uneventful healing, sufficient bone regeneration was obtained with this procedure to

allow for implant placement. It was demonstrated that RegenaformTM used as an only

graft material could minimize or eliminate the need for a donor site. This study shows

that RegenaformTM in combination with a collagen membrane provides a predictable

method for regenerating vertical bone up to 3 mm, with a mean of 0.54 mm and up to 6

mm of bone horizontally with a mean of 3.66 mm (maxilla= 2.64 mm and mandible=

4.28 mm).















CHAPTER 1
INTRODUCTION

Endosseous dental implant placement is often compromised when placed in

atrophic alveolar ridges. Ridge augmentation procedures are designed to widen ridges

prior to implant placement. Traditionally, only ridge augmentation procedures have

consisted of using an autogenous block graft from a separate surgical area such as the

ramus, chin, posterior ridge, and on occasion, the tibia, iliac crest, or ribs. This donor site

can be uncomfortable to the patient and leaves a potential for post-surgical complications.

The need for a donor site would be reduced if a graft material such as RegenaformTM

were shown to provide adequate volume and quality of new bone in previously atrophic

sites.














CHAPTER 2
BACKGROUND

The success and long term prognosis of endosseous implants in the treatment of

fully or partially edentulous patients has been well documented. 1,2,3 Adequate volume and

quality of bone in the edentulous area is required for acceptable functional and aesthetic

results.4 A minimum of 5 mm of ridge width is required for implant placement.5 (using

narrow diameter implants) When placing standard diameter implants, 4 mm, it has been

stated that a minimum of 6 mm of ridge width is required.6'7 Insufficient bone dimensions

result from excessive alveolar bone resorption that can occur following extractions,

trauma, or pathosis. This may prevent placement of fixtures in acceptable locations,

angulations, and lengths. As a result, endosseous dental implant placement is often

compromised when placed in atrophic alveolar ridges.

Ridge augmentation procedures are designed to widen ridges prior to implant

placement. Various grafting procedures have been utilized for grafting an edentulous

ridge, including, allograft, autograft or xenograft with or without a titanium re-enforced

membrane, ridge-splits, distraction osteogenesis, and only grafting with an autogenous

or allograft bone block. Traditionally, only ridge augmentation procedures have

consisted of using an autogenous block graft from a separate intra-oral surgical area such

as the ramus, chin, posterior ridge, or from extra-oral sites such as the tibia, iliac crest, or

ribs.8'9'10'11'12 The need for a second surgical site could be eliminated if a graft material

such as RegenaformTM, were shown to provide adequate volume and quality of new bone

in previously atrophic sites.









Graft Material

RegenaformTM was developed at the University of Florida Tissue Bank, now

known as Regeneration Technologies Inc. It is a bone paste allograft comprised of

decalcified freeze dried bone allograft (DFDBA) and 1-3mm size cortical cancellous

chips in a water insoluble thermoplastic porcine collagen gelatin carrier that resorbs in

approximately 10 days. It has a rigid rubbery consistency at room and body temperature

and becomes soft and moldable when warmed to 43 490 C in a heated water bath for

approximately 15 minutes. The DFDBA in RegenaformTM processed bone has proven to

be osteoinductive using the Urist- Strates model.13 Each batch is tested for

osteoinductivity by implanting the DFDBA intramuscularly in rats and checking for new

bone formation.

History of Ridge Augmentation

The same basic principle of guided tissue regeneration (GTR) has been used to

regenerate new bone in alveolar defects.14 Nyman et al (1990) was the first to publish the

enlargement of a reduced alveolar ridge.15 Siebert J, Nyman S (1990) were the first to

publish a study that evaluated the potential to reconstruct localized ridge defects with

bone (dog model).16 Buser, Bragger, Lang, Nyman (1990) published 9 successful cases of

ridge augmentations followed by implant placement in 7 humans.17 Since then, Becker &

Becker, Jovanovic, Buser et al have all documented successful regeneration of such of

reduced ridges implementing the principles of GTR. Ridge augmentation concepts

employed the same principles of specific tissue exclusion seen in GTR, but were not

associated with teeth. Therefore, the term applied to this procedure was guided bone

regeneration (GBR).









Membranes

Resorbable and non-resorbable membranes have been shown to be effective in

GBR procedures.18 Ridge augmentation can be predictably accomplished provided that

the membrane is properly adapted and complete closure is obtained throughout the

healing phase.19 If the membrane becomes exposed there is an increased possibility of

resorption and lack of continuity between the graft and host bone.20

Healing in Bone Regeneration

There are three mechanisms of healing that can take place with a bone graft.

Osteogenesis is when new bone is formed from live cells (autograft). Osteoconduction

occurs as a result of an inert scaffold which permits the in-growth of surrounding host

bone. And, osteoinduction, which is the formation of new bone by active recruitment of

host cells with the potential for osseous repair. For optimal bone regeneration to take

place, Lang et al established that an undisturbed healing period of at least six months is

required.

There are six generally agreed upon requirements for bone regeneration to take

place and are shown in below (Table 2-1). 21

Table 2-1: Requirements for Bone Regeneration and Surgical Procedures That Meet the
Required Criteria.
Biological Requirements Surgical Procedure
Blood Supply Cortical perforations
Stabilization Fixation screws, membranes
Osteoblasts Autogenous bone graft, cortical
perforations
Confined space (soft tissue exclusion) Barrier membrane
Space maintenance Tenting screws, Ti re-enforced membranes,
bone graft materials
Wound coverage Flap management, tension-free suturing














CHAPTER 3
AIM OF STUDY

The aim of the study was to determine volume changes of bone following ridge

augmentation with RegenaformTM by conducting a clinical trial compromised of a series

of augmentation surgeries to include collection of clinical measurements of the ridges

prior to and after a six month healing. Specific objectives are listed below:

1. To clinically measure the amount of horizontal and vertical bone gain obtained using

this bone allograft at different points along the ridge.

2. To determine the:

Amount of bone grafted.

Amount of bone gain.

Amount of graft resorption.

3. To assess the quality of bone at implant placement following a six month healing

period.

4. To compare the results obtained in the maxilla versus the mandible.














CHAPTER 4
NULL HYPOTHESIS

This material is effective in ridge augmentation for the purpose of future implant

placement. There is a correlation between graft resorption and location of graft

placement. The maxilla exhibits greater percentage of graft resorption.














CHAPTER 5
MATERIALS AND METHODS

Among the patients referred to the University of Florida, Graduate Periodontics

clinic for implant placement, 14 patients that required ridge augmentation procedures

prior to implant therapy were included in this study. Four of these patients required

multiple areas of ridge augmentation resulting in 19 surgical sites. If a patient required

more than one site, they were separated by at least a single tooth and were performed at

different times to allow healing of the surrounding tissues.

Inclusion Criteria

The following inclusion criteria were used:

* Partial edentulism with ridge deficiency.
* Both maxillary and mandibular arches were included.
* Horizontal and/or vertical deficiencies were included.
* Future implant treatment planned for site.
* Age limited to a minimum of 18 years of age.
* Males and females included.

Exclusion Criteria

The following exclusion criteria were used:

* Over a pack a day smokers.
* Diabetics (uncontrolled) or other severe systemic diseases.
* Pregnant or lactating.
* The need for antibiotic prophylaxis.
* Any other conditions contraindicating periodontal surgery.
* Unable to make all scheduled post-ops.
* Diagnosed with aggressive periodontitis.
* Patient allergic to porcine products.
* Patients unwilling to have porcine products used on them.









Sample Selection

Of the 19 surgical sites, 8 were on the maxilla and 11 on the mandible. Of the 14

patients selected, 4 were males and 7 females. Only one patient reported smoking. It was

in the form of 2-3 cigars per week. Ages range from 26-77 years of age with a mean age

of 56.

Two females (equaling 5 sites) reported taking oral bisphosphonates for

osteoporosis for over a 2 year period.

The sites were classified using the Siebert classification of ridge defects. 22

Table 5-1. Siebert Classification
Classification of Site Description of Loss
I Buccolingual with normal ridge height
II Apicocoronal with normal ridge width
III Buccolingual and apicocoronal

Table 5-2. Distribution of sites according to Siebert classification
Classification of Site # sites in each class
I 6
II 0
III 13

Custom Stents

Alginate impressions were taken prior to surgery and diagnostic casts were poured

in microstone. TriadTM acrylic was used to "build up" the ridge on the casts and allow

room for graft material underneath the stent. Measurements were collected using a

custom fabricated stent. 1.0 mm thick vacuform plastic sleeves were used to make

custom stent. A hole was created in the stents directly over the ridge in the area of

greatest deficiency and was designated the Vertical point. The Horizontal points were

created through the facial of the stents in a corono-apical direction at: 4 mm & 8 mm

apical to the alveolar crest. These holes correlated to the area of greatest horizontal









deficiency. Holes were created using a 169L bur. Measurements were then taken using a

UNC 15 probe placed through the holes created in the stent. The probe was maintained as

close to perpendicular to the stent as possible. Measurements were taken three times at

each site: (1)after flap reflection but before graft placement, (2) after graft placement, &

(3) at 5-7 month re-entry for implant placement.

Surgical Technique

The surgical procedures were carried out by two of the authors (A.S. & D.D). All

surgeries were performed under local anesthesia. Crestal incisions were made to the

lingual/palatal of the ridge while still in keratinized gingiva with divergent vertical

incisions only performed when needed to release tension on the flaps. Full thickness flaps

were reflected (Figure 2). After flap reflection, a UNC 15 mm probe was used to record

measurements, to the nearest millimeter, through the holes created in the stent, 1 vertical

point and 2 horizontal points (Figure 3). The cortical bone was perforated using a #2

round bur on high speed handpiece. Depth of penetration was extended only through the

cortical plate (Figure 4). Decortication is performed to allow angioneogenesis into the

grafted site.

A 0.5, 1, or 2 cc block was selected depending on number of implants desired and

size of augmentation required. Following cortical penetrations, the graft material was

then placed in a water bath and heated between 43 490 C for 10-15 minutes. The graft

was removed from the water bath once it became depressible to the touch. The graft

material was then molded and adapted to the defect (Figure 5). Once cooled to room

temperature, the graft material became solid allowing it to maintain the shape of the

defect and/or desired augmentation. Using the same stent, the measurements were taken

after graft placement, 1 vertical and 2 horizontal (4 & 8 mm). Type I bovine collagen









resorbable membranes were used for graft stabilization and soft tissue exclusion (Figure

6). Two different brands of membranes were used; BioMend Extend and Ace. One

site had an Ace collagen membrane used. The remaining 18 had BioMend Extend

membranes used. Prior to suturing, periosteal releasing incisions were performed until the

flap passively covered the grafted site. Tension free primary closure of the surgical site

was obtained (Figure 7). Suturing was completed using interrupted and mattress vicryl

sutures. Temporary removable partial dentures were adjusted until there was no contact

with the grafted area (Figure 8). Patients were asked to use the RPD as seldom as

possible.

Post-Operative Care

Post-operative antibiotics prescribed were: Augmentin 500 mg TID or Clindamycin

300 mg 1q6h for the first week of healing. Patients were instructed not to chew on the

area for approximately 2 weeks. Chlorhexidine (0.12%) rinse twice a day was instituted

for the first week. Patients were prescribed 600-800 mg of ibuprofen 1q6-8h for the first

3 days to help minimize swelling of the area. Analgesics were prescribed when needed.

Patients were seen for suture removal at 10-14 days. Further recall appointments were

scheduled at 1 month, 3 month, 5 month, & 6 months. At the 5 month recall, a panoral

radiograph was taken and impressions were obtained. These were used to fabricate a

surgical guide for implant placement. At 5-7 months the sites were re-entered (Figure 9).

The ridge was measured at the same points using the same custom stent as at the time of

graft surgery. Afterwards, implants were placed using one of the available implant

systems (3i InnovationsTM, StraumannTM, Astra TechTM, or Nobel BiocareTM).

























1lgure --1. Kidge pnor to ridge augmentation


Figure 5-2. Mucoperiosteal reflection


Figure 5-3. Collection of measurements using custom stent























Figure 5-4. Cortical penetrations


Figure 5-5. Graft adaptation


Figure 5-6. Collagen membrane placement























Figure 5-7. Tension-tree closure


Figure 5-8. This figure shows an example of a temporary removable partial denture.
Temporary RPDs were only made for Max anterior cases.


Figure 5-9. Re-entry at 6 months for implant placement














CHAPTER 6
RESULTS

Of the 14 patients that entered the study, 11 (4 males and 7 females) returned for

implant placement. One patient was dropped from the study due to inability to re-enter

within the 5-7 month period. One patient moved out the area. And, one patient dropped

out due to changes in their finances that did not allow implant placement. From the 11

returning patients, there were a total of 16 augmented sites. Ages range from 43-77 years

of age with a mean age of 59.

Two patients experienced membrane exposure, one of these patients experienced a

post-operative infection evident by pus flow from the vertical releasing incision. The

patient was seen at the 1st recall and given another week of antibiotics. This time,

clindamycin was prescribed. The infection was not clinically present by the 1 month

recall and the graft did not have to be removed. Subsequent implant placement was not

possible at re-entry due to excessive resorption and the site was grafted a second time.

This site will be referred to as IC (infected case) for the rest of this presentation. The

other patient experienced a larger membrane exposure that was managed by instructing

patient to saturate the exposed area with chlorhexidine 3 times per day. By the first month

recall, the site had closed and the membrane was no longer visible.

The results will be discussed in terms of amount bone gain (regeneration), amount

of graft resorption, amount grafted, % of graft resorption, quality of bone, and implant

survival.









Figures 6-1. Example of an experimental case. Complete series. (a) Multiple tooth site
#22-26. (b) Crestal incision with vertical releasing incisions #21 distal and
#27 distal. (c) Cortical perforations. (d) Adaptation of graft material to defect
and desired augmentation. (e) Resorbable collagen membrane trimmed to fit
over graft site. (f) Tension free primary closure using mattress and interrupted
sutures. (g) Graft site after 6 month healing. (h) Six month re-entry for
implant placement. (i) Implant placement. (j) Radiograph taken 2 months post
implant placement.






16















(c)














(d)






17














(e)












(f)












(g)


























(i)


.









Table 6-1.Bone Gain-RANGE
Measurement point Max or Mand (n) Range (mm)
Vertical Point Max(6) 0-1
Mand(7) 0-3
Max & Mand(13) 0-3
Horizontal 4mm point Max(6) 2-3
Mand(10) 1-6
Max & Mand(16) 1-6 w/o IC= 3-6
Horizontal 8mm point Max(5) 2-4
Mand(10) 3-6
Max & Mand(15) 2-6
Total horiz. (4&8 mm) Max(1 1) 2-4
Mand(20) 1-6
Max & Mand(31) 1-6 w/o IC= 1-6









Table 6-2.Bone Gain-AVERAGE
Measurement point Max or Mand (n) Average (mm)
Vertical Point Max(6) 0.33
Mand(7) 0.83
Max & Mand(13) 0.54
Horizontal 4mm point Max(6) 2.2
Mand(10) 4.0 w/o IC= 4.3
Max & Mand(16) 3.3 w/o IC= 3.5
Horizontal 8mm point Max(5) 3.2
Mand(10) 4.1 w/o IC= 4.2
Max & Mand(15) 3.8 w/o IC= 3.9
Total horiz. (4&8 mm) Max(1 1) 2.6
Mand(20) 4.1 w/o IC= 4.3
Max & Mand(31) 3.6 w/o IC= 3.7

Table 6-3. Resorption-RANGE
Measurement point Max or Mand (n) Average (mm)
Vertical Point Max(6) 0-4
Mand(7) 1-4
Max & Mand(13) 0-4
Horizontal 4mm point Max(6) 0-3
Mand(10) 1-4 w/o IC=1-4
Max & Mand(16) 0-4
Horizontal 8mm point Max(5) 0-4
Mand(10) 0-3 w/o IC= 0-3
Max & Mand(15) 0-4
Total horiz. (4&8 mm) Max( 1) 0-4
Mand(20) 0-4 w/o IC=0-4
Max & Mand(31) 0-4 w/o IC= 0-4

Table 6-4 Resorption-AVERAGE
Measurement point Max or Mand (n) Average (mm)
Vertical Point Max(6) 2.0
Mand(7) 1.6
Max & Mand(13) 1.8
Horizontal 4mm point Max(6) 2.0
Mand(10) 2.0 w/o IC=1.89
Max & Mand(16) 2.0 w/o IC=1.93
Horizontal 8mm point Max(5) 1.2
Mand(10) 1.40 w/o IC= 1.44
Max & Mand(15) 1.33 w/o IC= 1.36
Total horiz. (4&8 mm) Max(11) 1.6
Mand(20) 1.7 w/o IC= 1.7
Max& Mand(31) 1.7 w/o IC= 1.7










Measurement point Max or Mand (n) RANGE (mm)
Vertical Point Max(6) 1-4
Mand(7) 1-4
Max & Mand(13) 1-4
Horizontal 4mm point Max(6) 3-5
Mand(10) 4-8
Max & Mand(16) 3-8
Horizontal 8mm point Max(5) 4-8
Mand(10) 3-4
Max & Mand(15) 4-8
Total horiz. (4 & 8 mm) Max( 1) 3-5
Mand(20) 4-8
Max & Mand(31) 3-8

Table 6-6 Amount Grafted-AVERAGE
Measurement point Max or Mand (n) Average (mm)
Vertical Point Max(6) 2.0
Mand(7) 2.3
Max & Mand(13) 2.15
Horizontal 4mm point Max(6) 3.8
Mand(10) 6.0
Max & Mand(16) 5.2
Horizontal 8mm point Max(5) 4.2
Mand(10) 5.5
Max & Mand(15) 5.1
Total horiz. (4&8 mm) Max( 1) 4.0
Mand(20) 5.8
Max & Mand(31) 5.1

Table 6-7 Mean Percentage Resorption
Measurement point Max or Mand (n) % Resorption
Vertical Point Max(6) 58%
Mand(7) 81%
Max & Mand(13) 70%
Horizontal 4mm point Max(6) 45%
Mand(10) 34% w/o IC= 29%
Max & Mand(16) 38% w/o IC= 36%
Horizontal 8mm point Max(5) 26%
Mand(10) 24% w/o IC= 23%
Max & Mand(15) 24% w/o IC= 24%
Total horiz. (4 & 8 mm) Max(11) 38%
Mand(20) 29%w/o IC=27%
Max & Mand(31) 32%w/o IC=31%


Table 6-5 Amollmt CTt-afted-


-RANGE


















O Horizontal 4 mm
point
* Horizontal 8 mm
point
* Horizontal total (4
& 8 mm points)


Figure 6-2 Percentage of graft resorption. Infected case (IC) was excluded from this
chart.

Statistics for Percentage Graft Resorption

The following slides will show the mean, standard deviation, minimum, maximum,

and median percentage graft resorption for whole group, by sites and by gender groups.

With and without the IC (infected case).


Table 6-8 Mean and Standard Deviation with Infected Case (IC)
with IC
The MEANS Procedure

Variable N Mean Std Dev Minimum Maximum

ResorpV_p 13 70.4615385 39.331106 0 100

resorpH4_p 16 38.0625 19.7803564 0 75

resorpH8_p 15 24.3333333 20.7490677 0 80

resorpH4H8_p 16 32.4375 17.1501944 0 70


Median

100

39

25

33










Table 6-9.Means according to Arch with IC
with IC
The MEANS Procedure


site=L
Variable
ResorpV_p
resorpH4_p
resorpH8_p
resorpH4H8_p
site=U


Mean
80.85714296
33.9
23.5
29.2


Std Dev
28.4043927
17.8166589
13.8904444
12.0904002


Minimum
25
17
0
9


Maximum
100
75
43
50


Variable N Mean Std Dev Minimum Maximum
ResorpV_p 6 58.3333333 49.159604 0 100
resorpH4_p 6 45 22.5831796 0 60
resorpH8_p 5 26 32.6726185 0 80
resorpH4H8_p 6 37.8333333 23.7353464 0 70
No statistically significant difference between Upper and Lower arches.


Median
100
27
25
29

Median
75
50
25
41


Table 6-10.Means according to Gender with IC
with IC
The MEANS Procedure
gender=f


Variable
ResorpV_p
resorpH4_p
resorpH8_p
resorpH4H8_p
gender=m

Variable
ResorpV_p
resorpH4_p
resorpH8_p
resorpH4H8_p


Mean
66.6666667
39.0833333
28.3333333
34.25


Mean
79
35
8.3333333
27


Std Dev
45.0693909
19.3506323
20.5618063
16.3935963


Std Dev
25.1130776
23.8047614
14.4337567
20.800641


No statistically significant difference in % of graft resorotion between genders.


Minimum
0
17
0
9


Minimum
50
0
0
0


Maximum
100
75
80
70


Maximum
100
50
25
50


Median
100
33.5
25
33


Median
83
45
0
29










Table 6-11 Means and Standard Deviation without IC
without IC

The MEANS Procedure


Variable


N Mean


ResorpV_p

resorpH4_p

resorpH8_p


13 70.4615385 39.331106


15 35.6


17.7554821


14 24.2857143 21.5314745


resorpH4H8_p 15 31.2666667 17.0774148


Table 6-12.Means according to Arch without IC
without IC

The MEANS Procedure


site=L
Variable
ResorpVp
resorpH4_p
resorpH8_p
resorpH4H8_p
site=U
Variable
ResorpVp
resorpH4_p
resorpH8_p
resorpH4H8_p


Mean
80.8571429
29.3333333
23.3333333
26.8888889


Mean
58.3333333
45
26
37.8333333


Std Dev
28.4043927
11.0679718
14.7224319
10.2157286


Std Dev
49.159604
22.5831796
32.6726185
23.7353464


No statistically significant difference in % of graft resorption between upper and lower
arch.
Table 6-13.Means according to Gender without IC
without IC

The MEANS Procedure
gender=f


Variable
ResorpVp
resorpH4_p
resorpH8_p
resorpH4H8_p


Mean
66.6666667
35.8181818
28.6363636
32.8181818


Std Dev Minimum
45.0693909 0
16.467047 17
21.5372827 0
16.3879113 9


Std Dev Minimum Maximum


Median


100

38

25


Minimum
0
17
0
9


Minimum
0
0
0
0


Maximum
100
50
43
44


Maximum
100
60
80
70


Median
100
25
25
25


Median
75
50
25
41


Maximum
100
60
80
70


Median
100
29
25
33









Table6-13 continued
gender=m
Variable N Mean Std Dev Minimum Maximum Median
ResorpVp 4 79 25.1130776 50 100 83
resorpH4_p 4 35 23.8047614 0 50 45
resorpH8_p 3 8.3333333 14.4337567 0 25 0
resorpH4H8_p 4 27 20.800641 0 50 29
No statistically significant difference in % of graft resorption between genders.

Sites group and gender group were compared using parametric T-test and

nonparametric Wilcoxon Rank Sum test (because of small sample size and non-normal

distribution). There is no statistically significant difference in % resorption between

Maxillary and Mandibular groups, and between Female and Male groups. Also,

performed was two -way ANOVA (one factor is sites and the other factor is gender)

using the raw percent change parametricc way) and using ranks (nonparametric way,

again because of small sample size and non-normal distribution). Sites and gender both

have no significant effects on the percent changes. Finally, the interaction between sites

and gender was also tested in the two-way ANOVA models. There was no statistical

significance.

Quality of Bone

The two surgeons were asked to classify the type of bone encountered at implant

placement using the Misch bone density classification.

Misch Bone density classification:
* DI, similar to drilling into oak
* D2, similar to pine
* D3, similar to balsa
* D4, similar to Styrofoam

Distribution of bone the different bone densities encountered:
* Dl: 3 cases (1 upper, 2 lower)
* D2: 11 (5 upper, 6 lower)
* D3: 2 (2 upper)
* D4: 0 were classified as D4









Implant Survival

A total of 25 implants(3i InnovationsTM, StraumannTM, Astra TechTM, & Nobel

BiocareTM) were placed. Of the implants placed, their diameters were: 1 narrow

diameter, 3 wide diameter, and 21 standard diameter. To this date none of the implants

paced have failed. 11 have final restorations, the oldest being restored 16 months ago.

There were no buccal plate dehiscences at time of placement. Two ridge splits with

simultaneous implant placement were performed in maxillary anterior cases to further

augment the sites (Figure 10).

Figure 6-3 Ridge split performed on graft at implant placement. (a) Ridge split procedure
was performed on grafted bone at the #10 site. This was an area of membrane
exposure during the graft healing. (b) #10 implant placed at site of ridge split
procedure. (c) Implant placement. (d) Radiograph of implant placement.






27















(a)












(b)












(c)






28











S(d)







(d)














CHAPTER 7
DISCUSSION

Although this graft material is widely used, to this date there has never been a

documented clinical trial study performed using this material to show its clinical efficacy.

In the present study, the principle of GBR was applied using demineralized cortical

cancellous chips in a thermoplastic matrix in conjunction with a resorbable collagen

membrane for the purpose of placing dental implants. There was greater resorption

observed in the grafts placed in the maxilla than in the mandible. This has been

documented by others i.e. Adell et al, ten Bruggenkate CM, et al. 23,24 It has been

speculated that the increase blood supply offered in the maxilla may contribute to the

increases seen in graft resorption. Though vertical resorption may have been limited

using tenting devices, no such devices were used in this study in order to limit variables

and evaluate the raw potential of this graft material. No statistically significant difference

was observed between the maxilla and mandible. In all cases with uneventful healing,

sufficient bone regeneration was obtained with this procedure to allow for implant

placement.

Unlike autogenous block graft materials, this graft material was able to withstand

ridge splitting procedures at time of implant placement without consequence. It was

demonstrated that DFDBA and cortical cancellous chips in a thermoplastic matrix used as

an only graft material could minimize or eliminate the need for a donor site. This study

shows that when used alone this graft material provides a predictable method for






30


regenerating vertical bone up to 3 mm, with a mean of 0.54 mm and up to 6 mm of bone

horizontally with a mean of 3.66 mm (maxilla= 2.64 mm and mandible= 4.28 mm).




















APPENDIX A
STATISTICAL ANALYSIS


BY SITE


The TTEST Procedure



T-Tests


Variable
Resorpv_p
resorpH4_p
resorpH8_p
resorpH4H8_p


Variable


Resorpv_p
resorpH4_p
resorpH8_p
resorpH4H8_p


Method
Pooled
Pooled
Satterthwaite
Pooled


Variances
Equal
Equal
Unequal
Equal


DF
11
14
4.74
14


t Value
1.03
-1.09
-0.16
-0.97


Pvalue
0.3242
0.2925
0.8766
0.3470


Equality of Variances

Method Num DF Den DF F Value Pr > F


Folded F
Folded F
Folded F
Folded F


6 3.00
9 1.61
9 5.53
9 3.85


0.2142
0.5052
0.0315
0.0764


BY gender


The TTEST Procedure

T-Tests


Variable

Resorpv_p
resorpH4_p
resorpH8_p
resorpH4H8_p


Variable

Resorpv_p


Method

Pooled
Pooled
Pooled
Pooled


Method


Variances

Equal
Equal
Equal
Equal


DF t Value value


-0.51
0.35
1.57
0.72


0.6233
0.7338
0.1406
0.4832


Equality of Variances

Num DF Den DF F Value Pr > F


3 3.22 0.3651


Folded F












resorpH4_p
resorpH8_p
resorpH4H8_p


Folded F
Folded F
Folded F


1.51
2.03
1.61


0.5311
0.7524
0.4866


by site


13:32 Sunday, March 19, 2006


The NPAR1WAY Procedure

Wilcoxon Scores (Rank Sums) for Variable Resorpv_p
Classified by Variable site


Two-Sided Pr > IZ|


value= 0.4973


Wilcoxon Scores (Rank Sums) for Variable resorpH4_p
Classified by Variable site


Two-Sided Pr > IZ|


I value= 0.1750


Wilcoxon Scores (Rank Sums) for Variable resorpH8_p
Classified by Variable site


Two-Sided Pr > IZ|


I value= 0.6551


Wilcoxon Scores (Rank Sums) for Variable resorpH4H8_p
Classified by Variable site


Two-Sided Pr > IZ |I


value= 0.3157


By gender


Wilcoxon Scores (Rank Sums) for Variable Resorpv_p
Classified by Variable gender


Two-Sided Pr > IZ|


value= 0.9344


Wilcoxon Scores (Rank Sums) for Variable resorpH4_p
Classified by Variable gender


Two-Sided Pr > IZ|


value= 0.9520


Wilcoxon Scores (Rank Sums) for Variable resorpH8_p
Classified by Variable gender


Two-Sided Pr > IZ|


value= 0.1289


Wilcoxon Scores (Rank Sums) for Variable resorpH4H8_p
Classified by Variable gender

Two-Sided Pr > IZ| value= 0.7191
The TTEST Procedure


By site















DF t Value Pr > |t|


Resorpv_p
resorpH4_p
resorpH8_p
resorpH4H8_p


Pooled
Pooled
Pooled
Satterthwaite


Equality of Variances


Num DF Den DF F Value Pr > F


Resorpv_p
resorpH4_p
resorpH8_p
resorpH4H8_p


Folded F
Folded F
Folded F
Folded F


6 3.00
8 4.16
8 4.93
8 5.40


The TTEST Procedure


By gender


T-Tests


Variable

Resorpv_p
resorpH4_p
resorpH8_p
resorpH4H8_p


Method

Pooled
Pooled
Pooled
Pooled


Variances

Equal
Equal
Equal
Equal


DF t Value Pr > |t|


-0.51
0.08
1.52
0.57


0.6233
0.9405
0.1547
0.5789


Equality of Variances


Variable

Resorpv_p
resorpH4_p
resorpH8_p
resorpH4H8_p


Method

Folded F
Folded F
Folded F
Folded F


Num DF Den DF F Value Pr > F


3.22
2.09
2.23
1.61


0.3651
0.3305
0.6991
0.4964


Wilcoxon Scores (Rank Sums) for Variable Resorpv_p
Classified by Variable site
Two-Sided Pr > IZ| 0.4973

Wilcoxon Scores (Rank Sums) for Variable resorpH4_p
Classified by Variable site
Two-Sided Pr > IZ| 0.0771

Wilcoxon Scores (Rank Sums) for Variable resorpH8_p
Classified by Variable site
Two-Sided Pr > IZ| 0.6804

Wilcoxon Scores (Rank Sums) for Variable resorpH4H8_p
Classified by Variable site
Two-Sided Pr > IZ| 0.2123


Variable


T-Tests


Method


Variances


Equal
Equal
Equal
Unequal


11
13
12
6.25


1 .03
-1.80
-0.21
-1.07


Variable


0.3242
0.0945
0.8343
0.3260


Method


0.2142
0.0736
0.0535
0.0364








34


Wilcoxon Scores (Rank Sums) for Variable Resorpv_p
Classified by Variable gender
Two-Sided Pr > IZ| 0.9344

Wilcoxon Scores (Rank Sums) for Variable resorpH4_p
Classified by Variable gender
Two-Sided Pr > IZ| 0.9483

Wilcoxon Scores (Rank Sums) for Variable resorpH8_p
Classified by Variable gender
Two-Sided Pr > IZ| 0.1432

Wilcoxon Scores (Rank Sums) for Variable resorpH4H8_p
Classified by Variable gender
Two-Sided Pr > IZ| 0.8463

















APPENDIX B
RAW DATA


patient site gender Grated V ResorpionV %ResoationV grated H4 resotionH4 %resop H4 graed H resorp %iesorpH grfted H4&- rresop H4& %esorp H4&H8
RW L m 3 2 66 5 2 40 4 1 25 9 3 33
A U f 2 2 100 5 3 60 4 1 25 9 4 44
AJ2 L f 4 1 25 8 2 25 8 2 25 16 4 25
A3 L f 1 1 100 4 1 25 4 1 25 8 2 25
LR L f 0 0 0 6 1 17 5 0 0 11 1 9
-1 L f 0 0 0 8 4 50 8 3 38 16 7 44
D-2 L f 2 2 100 5 1 20 7 3 43 12 4 33
B8 U m 2 1 50 4 2 50 4 0 0 8 2 25
D-1 L f 4 3 75 5 1 20 4 1 25 9 2 22
D-2 L f 1 1 100 8 3 38 7 2 29 15 5 33
PC U f 1 1 0 5 3 60 5 4 80 10 7 70
JR U m 2 2 100 4 2 50 re re na 4 2 50
AS-1 L f 1 1 100 7 2 29 4 0 0 11 2 18
AS2IC L f 0 0 0 4 3 75 4 1 25 8 4 50
AH U f 1 0 0 4 2 50 4 1 25 8 3 38
DM U m 4 4 100 3 0 0 4 0 0 7 0 0















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BIOGRAPHICAL SKETCH

Dr. Angel R Santiago attended the University of Central Florida where he studied

molecular biology and microbiology. He graduated from Nova Southeastern University,

College of Dental Medicine, in May 2003. At this time Angel Santiago is attending the

University of Florida where he is completing his post-graduate residency in periodontics.