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A continued investigation into the capacity of Renew dentifrice to prevent white spot lesions associated with orthodontic treatment

Material Information

Title:
A continued investigation into the capacity of Renew dentifrice to prevent white spot lesions associated with orthodontic treatment
Creator:
Hoffman, Derek A
Place of Publication:
[Gainesville, Fla.]
Publisher:
University of Florida
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Language:
english
Physical Description:
1 online resource (35 p.)

Thesis/Dissertation Information

Degree:
Master's ( M.S.)
Degree Grantor:
University of Florida
Degree Disciplines:
Dental Sciences
Dentistry
Committee Chair:
WHEELER,TIMOTHY T
Committee Co-Chair:
MCGORRAY,SUSAN P
Committee Members:
RODY,WELLINGTON JOSE,JR
Graduation Date:
5/2/2015

Subjects

Subjects / Keywords:
Calcium ( jstor )
Dentifrices ( jstor )
Fluorides ( jstor )
Lesions ( jstor )
Orthodontics ( jstor )
Orthods ( jstor )
Sodium ( jstor )
Teeth ( jstor )
Tooth enamel ( jstor )
Toothpaste ( jstor )
Dentistry -- Dissertations, Academic -- UF
toothpaste
Genre:
Electronic Thesis or Dissertation
bibliography ( marcgt )
theses ( marcgt )
Dental Sciences thesis, M.S.

Notes

Abstract:
Introduction: White spot lesions represent a common, yet challenging, dilemma for orthodontists. Studies show incidence of white spot lesions in orthodontic patients to range from 30-50%. Fluoride has shown some benefit as a protective measure, however, this is usually insufficient in orthodontic patients. ReNewTM, a prescription strength dentifrice containing 5%, by weight, NovaMin (calcium sodium phosphosilicate bioactive glass) and 5000 ppm fluoride has been proposed to aid in prevention and reversal of white spot lesions. The primary aim of this study was to determine if the use of ReNewTM reduces formation of white spot lesions in orthodontic patients as compared to a control group. A secondary aim was to determine if the use of ReNewTM improves gingival health in orthodontic patients. Methods: Fifty patients undergoing orthodontic treatment in the graduate orthodontic clinic at the University of Florida were recruited to participate in this study. This was a prospective, double blind, randomized control trial. Patients were randomly allocated to either an active (ReNewTM ) or control group (Crest) by means of block randomization. Patients were enrolled in the study for one year and seen monthly for normal orthodontic appointments. Decalcification, gingival health and plaque was assessed and recorded at 3 month intervals. Assessment was done clinically by means of indices, decalcification was assessed on a scale of 0-4 using a modified version of the index developed by Gorelick.[1] Relative Streptococcus mutans and Lactobacillus levels were measured using the Caries Risk Test (CRT) bacteria kits at three month intervals as well. Results: Data for 44 patients was analyzed through 6 months of enrollment. Six patients were dismissed from the study for the following reasons: possible allergic reaction, not meeting inclusion criteria, early removal of orthodontic appliances and failure to make appointments. Statistical analysis was performed using both parametric and non-parametric tests. Results showed no difference between toothpastes in regard to improvement in white spot lesions, plaque or gingival health. Conclusions: Results of this study show there is no difference between a fluoride containing over the counter toothpaste versus ReNewTM in their effects at improving white spot lesions in orthodontic patients. ( en )
General Note:
In the series University of Florida Digital Collections.
General Note:
Includes vita.
Bibliography:
Includes bibliographical references.
Source of Description:
Description based on online resource; title from PDF title page.
Source of Description:
This bibliographic record is available under the Creative Commons CC0 public domain dedication. The University of Florida Libraries, as creator of this bibliographic record, has waived all rights to it worldwide under copyright law, including all related and neighboring rights, to the extent allowed by law.
Thesis:
Thesis (M.S.)--University of Florida, 2015.
Local:
Adviser: WHEELER,TIMOTHY T.
Local:
Co-adviser: MCGORRAY,SUSAN P.
Statement of Responsibility:
by Derek A. Hoffman.

Record Information

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UFRGP
Rights Management:
Applicable rights reserved.
Classification:
LD1780 2015 ( lcc )

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A CONTINUED INVESTIGATION INTO THE CAPACITY OF RENEWTM DENTIFRICE TO PREVENT WHITE SPOT LESIONS ASSOCIATED WITH ORTHODONTIC TREATMENT By DEREK A. HOFFMAN 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 2015

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2015 Derek A. Hoffman

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To my amazing wife , Susan, for all her support

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4 ACKNOWLEDGMENTS I would like to thank Dr. Tim Wheeler for his time, input and guidance into this research project. I would also like to thank Dr. Sue McGorray and Dr. Wellington Rody for their assistance and input regarding this research. I would like to thank Vicki Mayo and Marie Taylor for their assistance in project management. Thank you to Dr. Eddy Sedeno, Abby Tongco, Corina Murzi and all my co-residents for their assistance with this research. Finally, I would like to thank my wife, Susan, for her tremendous suppor t through this project and residency.

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5 TABLE OF CONTENTS page ACKNOWLEDGMENTS ................................ ................................ ................................ . 4 LIST OF TABLES ................................ ................................ ................................ ........... 6 LIST OF FIGURES ................................ ................................ ................................ ........ 7 LIST OF ABBREVIATIONS ................................ ................................ ............................ 8 ABSTRACT ................................ ................................ ................................ .................... 9 CHAPTER 1 INTRODUCTION ................................ ................................ ................................ ... 11 2 MATE RIALS AND METHODS ................................ ................................ ............... 16 3 STATISTICAL ANALYSIS ................................ ................................ ..................... 20 4 RESULTS ................................ ................................ ................................ .............. 21 5 DISCU SSION ................................ ................................ ................................ ........ 28 6 CONCLUSIONS ................................ ................................ ................................ .... 31 LIST OF REFERENCES ................................ ................................ .............................. 32 BIOGRAPHICAL SKETCH ................................ ................................ ........................... 35

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6 LIST OF TABLES Table page 4 -1 Baseline Comparison Measures ................................ ................................ ........ 23 4 -2 Gender by Group ................................ ................................ .............................. 23 4 -3 Race by Group ................................ ................................ ................................ .. 23 4 -4 Decalcification Index (DI) ................................ ................................ ................... 23 4 -5 Plaque Index (PI) ................................ ................................ .............................. 24 4 -6 Gingival Index (GI) ................................ ................................ ............................ 24 4 -7 Compliance by Group ................................ ................................ ........................ 24

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7 LIST OF FIGURES Figure page 4 -1 Mean DI score for each group 0-6 months ................................ ........................ 25 4 -2 Mean PI sc ore for each group 06 months ................................ ......................... 25 4 -3 Mean GI score 0-6 months ................................ ................................ ................ 26 4 -4 Correlation between age and Change in Decalcification Index (DI). .................. 26 4 -5 Correlation between Initial DI score and time in orthodontic treatment. ............. 27

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8 LIST OF ABBREVIATIONS CPP ACP Casein phosphopeptide amorphous calcium phosphate CRT Caries Risk Test DI GI OTC Oz PI PPM WSL Decalcification Index Gingival Index Over the counter Ounce Plaque Index Parts per million White spot lesion

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9 Abstract of Thesis Presented to the Graduate School of the University of Florida in Partial Fulfillment of the Requi rements for the Degree of Master of Science A CONTINUED INVESTIGATION INTO THE CAPACITY OF RENEWTM DENTIFRICE TO PREVENT WHITE SPOT LESIONS ASSOCIATED WITH ORTHODONTIC TREATMENT By Derek A Hoffman May 2015 Chair: Timothy T. Wheeler Major: Dental Scienc es Orthodontics White spot lesions represent a common, yet challenging, dilemma for orthodontists. Studies show incidence of white spot lesions in orthodontic patients to range from 30-50%. Fluoride has shown some benefit as a protective measure, however, this is usually insufficient in orthodontic patients. ReNewTM, a prescription strength dentifrice containing 5%, by weight, NovaMin (calcium sodium phosphosilicate bioactive glass) and 5000 ppm fluoride has been proposed to aid in prevention and rev ersal of white spot lesions. The primary aim of this study was to determine if the use of ReNewTM reduces formation of white spot lesions in orthodontic patients as compared to a control group. A secondary aim was to determine if the use of ReNewTM impr oves gingival health in orthodontic patients. Fifty patients undergoing orthodontic treatment in the graduate orthodontic clinic at the University of Florida were recruited to participate in this study. This was a prospective, double blind, randomized co ntrol trial. Patients were randomly allocated to either an active (ReNewTM) or control group (Crest) by means of block randomization. Patients were enrolled in the study for one year and seen monthly for normal orthodontic appointments. Decalcification,

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10 gingival health and plaque was assessed and recorded at 3 month intervals. Assessment was done clinically by means of indices, decalcification was assessed on a scale of 0-4 using a modified version of the index developed by Gorelick. [ 1 ] Relative Streptococcus mutans and Lactobacillus levels were measured using the Caries Risk Test (CRT) bacteria kits at three month intervals as well. Data for 44 patients was analyzed through 6 mo nths of enrollment. Six patients were dismissed from the study for the following reasons: possible allergic reaction, not meeting inclusion criteria, early removal of orthodontic appliances and failure to make appointments. Statistical analysis was perf ormed using both parametric and nonparametric tests. Results showed no difference between toothpastes in regard to improvement in white spot lesions, plaque or gingival health. Results of this study show there is no difference between a fluoride contain ing over the counter toothpaste versus ReNewTM in their effects at improving white spot lesions in orthodontic patients.

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11 CHAPTER 1 INTRODUCTION White spot lesions represent a common, yet challenging, dilemma for orthodontists. The presence of white spot lesions, upon completion of orthodontic treatment, can be a major detractor from what would otherwise be a great esthetic result. A study by Maxfield et al. [ 2 ] e valuated the attitudes of patients, parents, orthodontists and general practitioners in regards to various aspects of white spot lesions. The study revealed all groups found white spot lesions to be a detractor from the final esthetic result of orthodonti c treatment. Orthodontic appliances make oral hygiene more difficult and exacerbate retention of plaque; these aforementioned factors logically explain the increased incidence of white spot lesions in orthodontic patients. Management of white spot lesi ons varies by patient and can range from application of a fluoride varnish to restoration with composite or porcelain veneers. Both early detection and treatment of white spot lesions can prove difficult at times, making prevention a critical component of managing white spot lesions. ReNewTM, a prescription strength dentifrice containing 5%, by weight, NovaMin (calcium sodium phosphosilicate bioactive glass) and 5000 ppm fluoride has been proposed to aid in prevention and reversal of white spot lesions. White spot lesions are the earliest macroscopic evidence of enamel caries [ 3 ] . Increased plaque retention leads to an increased microbial load which prod uces acid that lowers the pH. Subsequently, there is an increase in the porosity of the enamel allowing penetration of microorganisms to the subsurface layer that is hindered in its ability to remineralize. The majority of demineralization leading to whi te spot lesions occurs in the subsurface region of enamel. [ 4 ] The outer 10 to 30 microns of enamel

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12 surface are believed to stay intact due to the supersaturation of fluoroapatite [ 5 ] . Calcium and phosphate ions have difficulty reaching the subsurface enamel layer to help remineralize[ 6 ] . Further, salivary proteins known to inhibit demineralization, such as proline-rich proteins and statherin, are not able to pass through the enamel pores to protect this sublayer13. This subsurface demineralization changes the refractive index of the enamel [ 7 ] and manifests clinically as a milky white opacity [ 8 ] , or white spot lesi on. Development of white spot lesions can occur rapidly. Studies by both O’Reilly et al . [ 9 ] and Ogaard et al . [ 10] both show development of clinically visible white spot lesions in orthodontic patients that occurred in four weeks, or less. This approximates a minimal time interval between consecutive orthodontic appointments. Clinical detection of white spot lesions is typically done by visual inspection. Russell [ 11] discusses differentiating fluorosis and white spot lesions. Fluorosis typically presents as white/yellowish lesions that blend with adjacent teeth structure and are therefore not well defined. Another key to identifying fluorosis is bilateral symmetry. White spot lesions in orthodontic patients are typically found near the bracket base and usually have a crescent shape. White spot lesions will also typically be detected under loose bands or as linear defects near the margin of the band [ 8 ] . Other possible means of detection include fluorescence based technology to identify tooth decalcification. Quantitative light -induced fluoroscopy (QLF) and DIAGNOdent are two such technologies that were compared in a study by Aljejani et al. [ 12] Findings from this study reports that QLF had a hig her correlation than DIAGNOdent in detecting early decalcification of enamel. However, this study was done in vitro and translation to clinical use may not prove as beneficial.

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13 Gorelick et al . [ 1 ] studied the incidence of white spot lesions in orthodontic patients. Results of this study showed almost 50% of orthodontic patients developed at least one white spot lesion during the course of treatment. Maxillary lateral incisors showed the highest incidence of white spot lesions, possibly attributed to the small surface area of tooth structure between the bracket base and gingival margin. Mandibular canines and first premolars were also particularly susceptible to development of white s pot lesions. Lovrov et al . [ 13] showed that one third of orthodontic patients developed at least one white spot lesion during orthodontic treatment. Lucheese et al . [ 14] calculated the incidence to be 43%, with 40% occurring within six months of commencing orthodontic treatment with fixed appliances. This study concluded that mandibular first molars closely followed by maxillary lateral incisors showed the highest incidence of white spot lesions. A study by Ogaard [ 15] revealed white spot lesions still represented an esthetic concern five years after completion of orthodontic treatment. Treatment of white spot lesions ranges from conservati ve initial treatment to more invasive restorative options. The following treatments represent the spectrum of treatment from least to most invasive: fluoride mouthwash or varnish, bleaching, microabrasion, composite restorations or porcelain veneers. The appropriate treatment of these lesions will be dependent on number of different factors including severity of the lesion and patient input [ 8 ] . More recently, resin infiltration has been shown to effectively and noninvasively mask white spot lesions. [ 16 , 17] NovaMin is the trade name for calcium sodium phosphosilicate bioactive glass. NovaMin’s origins date back to the creation of Bioglass in 1969 when a University of

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14 Florida researcher created a combination of calci um, sodium, silica and phosphorous to mend and accelerate bone growth. In the mid 1990’s Bioglass was adapted for treatment of dentinal hypersensitivity and this new formulation was called NovaMin. Later, it was realized that the mechanism of action to occlude dentinal tubules in the treatment of sensitivity could prove beneficial in the prevention and remineralization of incipient caries [ 18] . When immersed in an aqueous environment Na+ particles from the NovaMin begin to exchange with H+ ions. This allows for the release of calcium and phosphate from the calcium sodium phosphosilicate particles. The reaction of sodium ions with the hydrogen cations causes tr ansient increase in pH that facilitates precipitation of calcium and phosphate from both the NovaMin and saliva to form a calcium phosphate layer on the tooth surface. These reactions and depositions continue until the depositions eventually crystallize into hydroxycarbonate apatite. Hydroxycarbonate apatite is structurally and chemically similar to biological (hydroxy -) apatite. [ 19] Fluorid e alone has been proven to be beneficial in prevention and remineralization of incipient lesions. A study by Diamanti et al . [ 20] showed high fluoride concentrat ion dentifrices (greater than 2500 ppm) promoted remineralization and prevented demineralization more effectively than did lower fluoride concentration toothpastes or one containing calcium sodium phosphosilicate. However, according to Bishara et al . [ 8 ] , treatment of white spot lesions solely with a high fluoride concentration may be undesirable. The reasoning behind this statement is that application of the high fluoride concentration may mineralize the superficial layer, leaving the underlying demineralized structure of the subsurface layer relatively unaffected. They recommend

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15 lower fluoride concentrations whi ch would allow for slower penetration of fluoride and calcium. This proposed treatment should allow for more favorable resolution of white spot lesions. It has been proposed that a combination of fluoride and NovaMin is beneficial and synergistic in rem ineralization efforts. This is due to the ability of NovaMin to provide calcium and phosphorous ions in the production of fluorapatite. [ 6 , 18] The availability of these ions is normally the limiting factor in fluoride treatment. Additionally, the transient increase in pH created by NovaMin can help resist demineralization. NovaMin has also been shown to be beneficial in reducing gingivitis. A study by Tai et al . [ 21] showed improvement in gingival health, as measured by gingival bleeding and plaque indices, over a six w eek period with use of dentifrice containing NovaMin. The exact mechanism of NovaMin’s antibacterial property remains unclear, it is proposed that the sodium and calcium content of NovaMin effects bacterial liquid balance[ 22 ] . The primary aim of this study was to determine if the use of ReNewTM reduces formation of white spot lesions in orthodontic patients as compared to a control group. A secondary aim was to determine if the use of ReNewTM improves gingival health in orthodontic patients.

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16 CHAPTER 2 MATERIALS AND METHODS The study protocol was reviewed and approved by the Institutional Review Board at the University of Florida, study 3292011. Fifty patients receiving routine orthodontic care in the graduate orthodontic clinic at the U niversity of Florida were enrolled in this study. This prospective, double blind, randomized clinical trial follows up on an initial investigation by Drew Clark, DMD, MS. Dr. Clark enrolled and collected data on the first twenty subjects of this sample. Inclusion criterion for participation in the study were patients (1) between the ages of 12 and 25 with moderate or poor oral hygiene (as determined by a mean plaque index for anterior teeth of 2.5 or greater), (2) with a medical history that would not pr eclude dental treatment, (3) at least 6 months of orthodontic treatment remaining, (4) fixed orthodontic appliances present on all maxillary and mandibular anterior teeth and (5) currently under the care of a general dentist. Informed consent was obtained from the patient, or parent/legal guardian if under the age of 18, before participation in the study. Patients with (1) excellent oral hygiene, (2) active dental caries, (3) positive pregnancy test or (4) active periodontal disease were excluded from the study. After clinical exam and review of medical history to ensure potential subjects met enrollment criteria, informed consent was reviewed and given to patient and/or parent. An appointment for the baseline, or initial, study appointment was made at t his time. At the initial appointment a salivary sample was obtained in order evaluate relative concentrations (high or low) of Streptococcus mutans and Lactobacillus via CRT bacteria test. Next, the patient’s plaque index was assessed and recorded for al l anterior teeth after the patient disclosed with plaque disclosing solution. Three intraoral

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17 photographs were captured and stored in Dolphin Imaging to document the plaque index of the patient. A dental cleaning was given to the patient using a Prophy -J et and scalers then polished with prophy cups and paste. Decalcification and gingival indices were assessed and recorded after teeth were thoroughly dried. Three more intraoral photographs were taken to document any white spot lesions present and gingival conditions. Subjects were randomly assigned to the treatment or control group by means of block randomization. The control group received a tube of Crest over the counter toothpaste, while the study group received a tube of ReNewTM. All toothpaste wa s covered with blinding labels and weighed before being dispensed to subjects. Subjects were instructed to bring the old tube of toothpaste to each appointment. At the conclusion of the baseline appointment toothpaste, floss, toothbrush and study instruc tions were dispensed then oral hygiene instructions were reviewed. The patient was seen monthly at which time old toothpaste was collected, new toothpaste was dispensed and oral hygiene instructions were reviewed. Toothpaste was also weighed after collec tion as a means to measure patient compliance. Three month, six month and nine month appointments were the same as the initial appointment with the exception that no cleaning was given and old toothpaste was collected. The final appointment was similar t o the nine month appointment except that no toothpaste was dispensed and the patient was dismissed from the study. The decalcification index used in the study was a modified version of the white spot lesion index developed by Gorelick et al. [ 1 ] The modified decalcification index scores individual teeth as follows (0) no white spot lesion present, (1) visible white spots without surface interruption (mild decalcification), (2) visible white spot lesion

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18 having a roughened surface but not requiring a restoration (moderate decalcification), (3) visible white spot lesion with surface interruption (severe decalcification) and (4) cavitation. The modified gingival index used ranks gingival inflammation on a scale of 0 -4. The scoring for the modified gingival index, defined by Lobene et al . , is (0) normal (no inflammation), (1) mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit, (2) mil d inflammation of the entire gingival unit, (3) moderate inflammation (moderate glazing, redness, edema and/or hypertrophy) of the entire gingival unit, (4) severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding or ulceration) of t he gingival unit. The plaque index used in this study was the Turesky modification of the Quigley -Hein index. Scoring used for this index is on a 0-5 scale and is defined as (0) no plaque, (1) separate flecks or discontinuous bands of plaque at the gingi val margin, (2) thin (up to 1mm), continuous band of plaque at the gingival margin, (3) band of plaque wider than 1mm but less than 1/3 of the tooth surface, (4) plaque covering between 1/3 and 2/3 of the tooth surface, (5) plaque covering more than 2/3 of the tooth surface. Teeth scored in this study were the maxillary and mandibular permanent anterior dentition (upper and lower 3-3). Inter -examiner reliability was assessed between two investigators ( Drew Clark and Derek Hoffman) by the author scoring t he indices of five randomly selected patients and time points from the initial study sample (n=20). Five additional patients and time points were selected where the author just scored DI. Scoring of the indices by use of photographs stored in Dolphin Ima ging was compared to the actual data collected. Inter -examiner reliability was assessed as moderate due to difference between scoring clinically and retrospectively. D r. C lark the scored the same photographs in Dolphin

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19 Imaging and reliability scores impr oved. Additionally, comparison of baseline scores between the two investigators showed no statistically significant difference.

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20 CHAPTER 3 STATISTICAL ANALYSIS Data was initially analyzed using parametric tests, as data for the initial twenty subjects of the sample appeared normally distributed. Paired t -tests were used to compare differences for each index between the two groups (ReNew and placebo) between time points. Paired t -tests were also used to compare data collected between the two different investigators. A significance level of p=0.05 was set as the threshold for the t -tests. Wilcoxon rank sum test, a non-parametric test, was also used to evaluate any differences between the two groups. While we expected outcome variables to be normally dis tributed, differences between parametric and non-parametric testing would alert us to cases where this may not be true. Chi -square tests, Fisher exact test, two sample t -tests and Wilcoxon rank sum tests were used to analyze any significant differences i n regards to sex, race, age and time in treatment between the ReNew and placebo groups. The same tests were also used to look at the same differences between subjects enrolled by each investigator. Both Spearman and Pearson correlation tests were used t o determine correlation between age, time in treatment and DI score.

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21 CHAPTER 4 RESULTS Statistical analysis showed the ReNewTM and placebo groups were similar regarding a number of variables at the initial time point. DI, GI and PI scores were all simila r; as was age, gender, race and time in treatment (Tables 4-1, 4-2, 4-3). No statistically significant differences were found between ReNewTM and Crest OTC dentifrices in regards to white spot lesions, plaque index or gingival health (Figure 4 -1, 4-2, 4 -3 and Tables 4-4, 4-5, 4-6). Therefore, we failed to reject the null hypothesis. There was a trend toward improvement in white spot lesions found in subjects using Crest at the 3 month time point (This reached statistical significance using parametric testing p=0.0403). Likewise, the ReNewTM group showed a trend toward improvement in gingival health at the three month time point. None of these improvements were realized at the six month time point. There was no statistically significant difference between the control and treatment groups at the six month time point for all three indices. Data after six months was not included due to the small sample size. No difference was found between groups in regards to compliance (Table 4 -7). 41.7% of subjec ts in each group were non-compliant with usage of dispensed toothpaste. Relative bacteria counts of Streptococcus mutans and Lactobacillus (high or low) were assessed between the ReNewTM and Crest groups and no statistically significant difference was found.

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22 Analysis showed a negative correlation with age and change in DI over time, i.e. older subjects showed a smaller change in DI score (Figure 4-4). There was also a positive correlation between years in treatment and initial DI score (Figure 4 -5).

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23 Ta ble 4 1. Baseline Comparison Measures ReNew TM Crest P Value (t test, WRST)* Mean DI Score 0.333 0.33 (0.27, 0.45) Mean GI Score 2.142 2.153 (0.95, 0.65) Mean PI Score 3.035 3.413 (0.27, 0.45) Mean Age 15.6 15.3 (0.63, 0.85) Tx Time* 1.5 1.2 (0.23 , 0.44) P value was set at 0.05, no significant difference between groups at initial timepoint. *Tests used were two sample t test and Wilcoxon Rank Sum Test Table 4 2. Gender by Group ReNew TM Crest Females 7 (29.2%) 9 (37.5%) Males 17 (70.8% ) 15 (62.5%) p=0.54. No significant difference between groups Table 4 3. Race by Group ReNew TM Crest Non White 4 (16.7%) 6 (25.0%) Caucasian 20 (83.3%) 18 (75.0%) p=0.72. No significant difference between groups. Table 4 4. Decalcification Index (DI) N Mean Median St Dev Min Max p value (t test, WRST) Baseline ReNew 24 0.333 0.208 0.335 0 1.167 Baseline Crest 24 0.33 0.25 0.399 0 1.333 0.97, 0.66 3 Month ReNew 24 0.476 0.333 0.439 0 1.417 3 Month Crest 23 0.239 0.167 0.302 0 1.25 0.0403*, 0.05 6 Month ReNew 23 0.471 0.417 0.371 0 1.583 6 Month Crest 21 0.44 0.25 0.47 0 2.083 0.81, 0.5 P Value was set at 0.05 *There was a significant difference between groups at 3 months, although it was not realized at 6 months .

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24 Table 4 5. Plaque Index (PI) p value (t test, WRST) N Mean Median St Dev Min Max Baseline ReNew 24 3.035 3.25 1.331 0 4.917 Baseline Crest 26 3.391 3.625 0.934 1.583 5 0.27, 0.45 3 Month ReNew 24 3.222 3.417 1.155 1.167 5 3 Month Cres t 23 3.475 3.333 0.895 1.75 4.833 0.41, 0.61 6 Month ReNew 23 3.529 3.417 1.093 1.917 5 6 Month Crest 21 3.861 4.087 1.072 1 5 0.32, 0.32 P Value was set at 0.05 There was no significant difference between groups Table 4 6. Gingival Index (GI) N Mean Median St Dev Min Max p -value (t -test, WRST) Baseline ReNew 24 2.142 2.125 0.612 1.417 3.833 Baseline Crest 24 2.153 2.25 0.467 1.25 3 0.95, 0.65 3 Month ReNew 24 2.149 2.042 0.521 1.167 3 3 Month Crest 22 2.348 2.25 0.426 1.667 3. 167 0.17, 0.15 6 Month ReNew 23 2.424 2.333 0.56 1.333 3.417 6 Month Crest 21 2.496 2.417 0.626 1.333 4 0.69, 0.92 P Value was set at 0.05 There was no significant difference between groups. Table 4 7. Compliance by Group ReNew TM Crest Compl iant 14 (58.3%) 14 (58.3%) Non Compliant 10 (41.7%) 10 (41.7%) Total 24 (100%) 24 (100%)

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25 Figure 4-1. Mean DI score for each group 0-6 months . (Note: Statistically significant difference found at 3 months. This was not realized at 6 months. ) Figure 4-2. Mean PI score for each group 0-6 months. (Note: No statistically significant difference found at 6 months ) 0 0.1 0.2 0.3 0.4 0.5 0 3 6DI Score Time (Months ) Decalcification Index 0-6 Months ReNew Mean DI Crest Mean DI * 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 0 3 6Mean PI Score Time (months) Plaque Index 0 -6 Months ReNew Crest

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26 Figure 4-3. Mean GI score 0-6 months. (Note: No statistically significant difference found at 6 months ) Figure 4-4. Cor relation between age and Change in Decalcification Index (DI). 1.9 2 2.1 2.2 2.3 2.4 2.5 2.6 0 3 6 GI Score Time (months) Gingival Index 0-6 months ReNew Crest -0.6 -0.4 -0.2 0 0.2 0.4 0.6 0.8 1 10 15 20 25Change in DI score 0 6 months Age (in years) Correlation between Age and change in DI Age and change in DI Linear (Age and change in DI )r= 0.35

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27 Figure 4-5. Correlation between Initial DI score and time in orthodontic treatment. -0.6 -0.4 -0.2 0 0.2 0.4 0.6 0.8 1 10 15 20 25Change in DI score 0 6 months Age (in years) Correlation between Age and change in DI Age and change in DI Linear (Age and change in DI )r= 0.35

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28 CHAPTER 5 DISCUSSION Use of calcium and phosphorous to prevent and/or reverse white spot lesions show s promise in research studies [ 23 ] , [ 24] , [ 25] . Ther e are many different delivery systems for calcium and phosphorous compounds. For the purpose of comparing our results with that of other research, we will consider all delivery vehicles to be equally effective. In reality this is probably not the case, as supported by a review by Walsh [ 26] . Results of this study are in agreement with a study by Huang et al . [ 27] that showed no improvement between MI Paste Plus, PreviDent mouthwash and s tandard homecare regarding improvement of white spot lesions over an eight week period. Results are also in agreement with the in vitro study by Ballard et al . [ 28] who tested Restore (which contains NovaMin), Prevident 5000 and MI Paste Plus. Results of this study showed none of these products were more effective at esthetically resolving white spot lesions than a control. A study by Robertson et al . [ 23] in 2011, revealed a statistically significant improvement in white spot lesions using MI Paste Plus, as compared to a control, Tom’s of Maine toothpaste. In this study fifty patients were followed for three months. Results showed a 53.5% decrease in decalcification index scores in the MI Paste Plus group, while the placebo group showed a 91.1% increase. Possible reasons for the difference in this study may be due to t he scoring system used which measured decalcification on a 0-3 scale based on size and did not take into account surface roughness. This scoring system also divided the facial surface of the tooth into quadrants (mesial, distal, incisal and gingival) incr easing the amount of data points available, thereby making any

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29 difference easier to detect. Scoring was also assessed by means of photographs which may not be as clinically accurate and could possibly induce bias. The role of fluoride in prevention of tooth decalcification is well documented. [ 9 , 20, 29, 30] However, there is debate regarding the amount of fluoride that should be prescribed when remineralization of subsurface enamel is desired[ 8 , 26 ] . A limiting factor in gaining remineralization, or reversal, of white spot lesions during this study may have been the relatively high concentration of fluoride in the ReNewTM. High concentrations of fluoride will lead to re-mineralization of the surface layer with fluorapatite, which may inhibit remineralization of subsurface layers. [ 8 ] This reasoning may help explain the improvement seen in the Crest group at the three month mark. Low levels of fluoride working in conjunction with calcium and phosphorous found in saliva may have led to a temporary improvement in white spot lesions. This transient improvement was eventually overcome by the acidic attack from increasing plaque levels. This group may have also shown a transient improvement in hygiene, and hence white spot lesions, for 1-2 months simply because they knew they were enrolled in a study evaluating oral hygiene. One vehicle which may be beneficial in providing the calcium and phosphorous limiting re mineralization is by encouraging patients to chew gum with casein phosphopeptide – amorphous calcium phosphate (CPP -ACP). This in combination with fluoride levels found in OTC toothpastes may encourage reversal of white spot lesions in orthodontic patients. Another means to possibly reverse white spot lesions with CPP ACP would be application of GI Paste Plus, after application of phosphoric acid on the WSL for 30 seconds. Application of phosphoric acid has proven beneficial in removing

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30 surface proteins and fluorapatite for resin infiltration procedures. Further research is warranted to elucidate clinically predictable methods to prevent or reverse white spot lesions, particularly in orthodontic patients. Limitations of this study include plaque and gingival hyperplasia preventing a completely accurate assessment of white spot lesions. After rinsing with disclosing agent, patients were instructed to brush until all plaque was removed. However, some plaque typically remained especially in hard to reach areas. A scaler was used to remove any remaining plaque, although given clinical time restraints this was difficult sometimes. Patient compliance is another limitation of this study. Compliance, as measured by the weight of returned toothpaste appears equal between both groups. However, if a patient did return old tubes of toothpaste at monthly visits the patient was considered non-compliant, when in reality they may have been compliant. A final limitation of this study may have been the decalcification index used. This index is slightly subjective and rated white spot lesions on a 0-4 scale where patients rarely reached a score of 2 or higher. These patients typically showed white spot lesions on only a couple anterior teeth. This may have made detecting a true difference more difficult. Future st udies may consider using fluorescence technology. As a final remark, Sultan Healthcare the manufacturers of ReNew have ceased production of this product for business reasons.

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31 CHAPTER 6 CONCLUSIONS Results of this study show there is no difference between an over the counter fluoride containing toothpaste versus ReNew dentifrice in their effects at improving white spot lesions in orthodontic patients. The results of this study also show there is no difference between ReNew and an over the counter toothpaste in regards to improvement in gingival health in orthodontic patients.

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32 LIST OF REFERENCES 1. Gorelick L, Geiger A, Gwinnett AJ . Incidence of white spot formation after bonding and banding. Am J Orthod Dentofacial Orthop 1982; 81(2): 93-98. 2. Maxf ield BJ, Hamdan AM, Tufekci E, Shroff B, Best AM, Lindauer SJ. Development of white spot lesions during orthodontic treatment: perceptions of patients, parents, orthodontists, and general dentists . Am J Orthod Dentofacial Orthop 2012; 141(3): 337-44. 3. Ca i F, S.P., Morgan MV, Reynolds EC . Remineralization of enamel subsurface lesions in situ by sugar free lozenges containing casein phosphopeptideamorphous calcium phosphate. Aust Dent J 2003; 48(4): 240243. 4. Summitt J, R.J., Hilton T, Schwartz R . Funda mentals of Operative Dentistry . 3rd ed. 2006; Hanover Park, IL: Quintessence Publishing. 5. Larsen MJ. Chemical events during tooth dissolution. Journal of Dental Research 1990; 69 : 575-580. 6. Reynolds, E.C., Calcium phosphate-based remineralization syste ms: scientific evidence? Aust Dent J 2008; 53(3): 268-73. 7. Mann AB, D ickinson M E. Nanomechanics, chemistry, and structure at the enamel surface. Monogr Oral Sci 2006 ; 19: 105-131. 8. Bishara S E, Ostby AW . White Spot Lesions: Formation, Prevention, and T reatment . Seminars in Orthodontics 2008; 14(3): 174-182. 9. O'Reilly MM, F eatherstone J. Demineralization and Remineralization around orthodontic appliances: An in vivo study . Am J Orthod Dentofacial Orthop 1987; . 92(1): 33-40. 10. Ogaard B, R ella G, Arends J. Orthodontic Appliances and Enamel Demineralization. Part 1. Lesion Development . Am J Orthod Dentofacial Orthop 1988; 94 (1): 68-73. 11. Russell AL . The differential diagnosis of fluoride and nonfluoride enamel opacities . J Public Health Dent 1961; 21(4): 143-146. 12. Aljehani A, T ranaeus S, Forsberg CM, Mansson BA, Shi XQ . In vitro quantification of white spot enamel lesions adjacent to fixed appliances using quantitative light -induced fluorescence and DIAGNOdent . Acta Odontologica Scandinavica 2004; 62: 313-318. 13. Lovrov S, H ertrich K, Hirschfelder U . Enamel Demineralization during Fixed Orthodontic Treatment --Incidence and Correlation to Various Oral -hygiene parameters . J Orofac Orthop 2007; 5 : 353-363.

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33 14. Lucchese A, Gherlone E. Prevalence of w hite-spot lesions before and during orthodontic treatment with fixed appliances . Eur J Orthod 2013; 35: 664668. 15. Ogaard B . Prevalence of white spot lesions in 19year olds: A study of untreated and orthodontically treated persons five years after t reatment . Am J Orthod Dentofacial Orthop 1989 ; 96: 423-427. 16. Yim HK, K won H K, Kim BI . Modification of surface pre-treatment for resin infiltration to mask natural white spot lesions . Journal of Dentistry 2014; 42(5): 588-594. 17. Eckstein A, Helms HJ , K nosel M. Camouflage effects following resin infiltration of postorthodontic white-spot lesions in vivo: One-year follow up. Angle Orthod 2014. 18. Burwell A, Litkowski L J, Greenspan D C. Calcium sodium phosphosilicate (NovaMin): remineralization potential . Adv Dent Res 2009; 21(1): 35-9. 19. Andersson OH, K angasniemi I. Calcium phosphate formation at the surface of bioactive glass in vitro. J Biomed Mater Res 1991; 25 (8): 1019-1030. 20. Diamanti I, Kolets -Kounari H, Mamai Homata E, Vougiouklakis G . Effec t of fluoride and of calcium sodium phosphosilicate toothpastes on pre-softened dentin demineralization and remineralization in vitro. J Dent 2010; 38(8): 671 -7. 21. Tai BJ, Bian Z , Jiang H, Greenspan DC, Zhong J, Clark AE, Du MQ. Anti gingivitis effect of a dentifrice containing bioactive glass (NovaMin) particulate. J Clin Periodontol 2006; 33(2): 8691. 22. Vahid Golpayegani M, S ohrabi A , Biria M, Ansari G. Remineralization Effect of Topical NovaMin Versus Sodium Fluoride (1.1%) on Caries -Like Lesions in Permanent Teeth. Journal of Dentistry, Tehran University of Medical Sciences, 2012; 9 (1): 68-75. 23. Robertson MA, Kau CH, English JD, Lee RP, Powers J, Nguyen JT. MI Paste Plus to prevent demineralization in orthodontic patients: a prospective randomi zed controlled trial. Am J Orthod Dentofacial Orthop 2011; 140(5): 660-8. 24. Reynolds EC, Cai F, Shen P, Walker GD . Retention in Plaque and Remineralization of Enamel Lesions by Various Forms of Calcium in a Mouthrinse or Sugar -free Chewing Gum . Journal of Dental Research 2003 ; 82(3): 206-211. 25. Bailey D L, Adams GG, Tsao CE, Hyslop A, Escobar K, Manton DJ, Reynolds EC, Morgan MV . Regression of post orthodontic lesions by a remineralizing cream . J Dent Res 2009; 88(12): 1148 -53.

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34 26. Walsh LJ . Contempor ary technologies for remineralization therapies: A review . International Dentistry SA 2009; 11 (6): 6 -16. 27. Huang GJ, R oloff -C hiang B, Mills BE, Shalchi S, Spiekerman C, Korpak AM, Starrett JL, Greenlee GM, Drangsholt RJ, Matunas JC . Effectiveness of MI Paste Plus and PreviDent fluoride varnish for treatment of white spot lesions: A randomized controlled trial. Am J Orthod Dentofacial Orthop 2013; 143(1): 31-41. 28. Ballard RW, Hagan JL, Phaup AN, Sarkar N, Townsend JA, Armbruster PC . Evaluation of 3 comm ercially available materials for resolution of white spot lesions . Am J Orthod Dentofacial Orthop 2013; 143(4 Suppl): p. S78-84. 29. Yamazaki H, Litman A, Margolis HC. Effect of fluoride on artificial caries lesion progression and repair in human enamel: regulation of mineral deposition and dissolution under in vivo-like conditions. Arch Oral Biol 2007; 52(2): 11020. 30. Marinho VCC, H iggins J, Logan S, Sheiham A. Benefits of topical fluorides firmly established. Evidence Based Dentistry, 2004; 5 : 36-37.

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35 BIOGRAPHICAL SKETCH Derek Hoffman was born and raised in Ocala, Florida. He completed his undergraduate studies at the University of Florida in 2002, graduating with a B.S. in Business Administration. He then worked in retail management for over four y ears. He enrolled at the College of Charleston in 2006 to fulfill prerequisites for dental school. He attended dental school at the Medical University of South Carolina, graduating in 2012. He completed his orthodontic residency at the University of Florida g raduating in May 2015. Derek and his wife have been married since 2004. Together, they have two children, Ellie who is 4 and Miles who is 2. They are expecting their third child v ery soon. When Derek is not treating patients, reading ABO articles, tracing cephs or thumbing through the AJO -DO, he enjoys spending time with his family. He also enjoys golf and surfing. Derek works in private practice in Orange Park, Florida.