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Long-Term Comparison of Treatment Impacts between Invisalign and Fixed Appliance Therapy


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1 LONG-TERM COMPARISON OF TREATMEN T IMPACTS BETWEEN INVISALIGN AND FIXED APPLIANCE THERAPY By AARON W. CARROLL 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 2007

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2 Aaron W. Carroll

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3 ACKNOWLEDGMENTS I thank the chair and members of my supervis ory committee for their me ntoring, the staff and members at the UF Libraries for th eir keen research assistance, the participants in my surveys for their honest and open participation. I thank Dr. Randol Womack for his assistance in enrolling participants in my study.

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4 TABLE OF CONTENTS page ACKNOWLEDGMENTS...............................................................................................................3 LIST OF TABLES................................................................................................................. ..........5 LIST OF FIGURES................................................................................................................ .........6 ABSTRACT....................................................................................................................... ..............7 CHAPTER 1 INTRODUCTION...............................................................................................................8 2 MATERIAL AND METHODS.........................................................................................10 3 STATISTICAL ANALYSIS.............................................................................................12 4 RESULTS..........................................................................................................................13 5 DISCUSSION....................................................................................................................16 6 CONCLUSION..................................................................................................................18 APPENDIX A DAILY DIARY QUESTIONNAIRE................................................................................19 LIST OF REFERENCES............................................................................................................. ..21 BIOGRAPHICAL SKETCH.........................................................................................................23

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5 LIST OF TABLES Table page 4-1 Group demographics data..................................................................................................13 4-2 Group socioeconomic data and mean PAR scores............................................................14

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6 LIST OF FIGURES Figure page 4-1 Mean pain levels........................................................................................................... .....14 4-2 Quality of life............................................................................................................ .........15

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7 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 A LONG-TERM COMP ARISON OF TREATMENT IMPACTS BETWEEN INVISALIGN AND FIXED APPLIANCE THERAPY By Aaron W. Carroll May 2007 Chair: Timothy Wheeler Major: Dental Sciences A recent study found subjects treated with Invisalign appliances reported significantly less pain and negative impact on daily life during the first week of treatment than did subjects treated with fixed orthodontic appliances. The aim of this st udy was to dete rmine if these differences persist throughout treatment. Eighteen of twenty-five subjects, twelve to fifteen months into treatment at the University of Florida College of Dentistr y and at a private orthodontic practice, completed one week surv eys to measure the psychosocial and pain related impact of orthodontic treatment with either Invisalign or fixed appliances. There were no significant differences found between groups wi th respect to age, race, educati on, income or severity of initial malocclusion. Also, no significant differences in pain levels or impact on daily life between the two groups were reported. Based on a limited number of subjects the results of this study suggest that the higher pain levels and greater impact on daily life experienced during the first week of treatment by patients treated with fixed appliances compared to those treated with Invisalign may not persist throughout the duration of treatment.

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8 CHAPTER 1 INTRODUCTION Much of the orthodontic literature regardi ng orthodontic treatment with Invisalign is limited to case reports, and descriptions of tec hnique and mechanics. Few studies have compared treatment with Invisalign to more traditional fixed appliances. Djeu 1 reported Invisalign treatment to be less effective in occlusal and ante ro-posterior corrections in a retrospective study based on a comparison of finish ed cases using the American Bo ard of Orthodontics (ABO) scoring methods. It was found that aligners were particularly effective in correcting rotations and marginal ridge discrepancies, however. Plaque scores have been shown to be better in patients treated with Invisalign. 2 This was attributed to improved access fo r oral hygiene. Due to the weak evidence in the literature and lack of random ized clinical trials, no strong conclusions can be made regarding comparative treatment efficiency. 3 The orthodontic literature addres sing the treatment experience s of orthodontic patients is relatively limited. 4 Other than length of treatment, pain is the most frequent complaint during orthodontic treatment. 5,6 This pain has been described as being more severe than the pain experienced following dental extractions. 7 The pain experience following initial appliance placement or activation has been shown to follow a certain pattern, peaking at approximately 24 hours, then returning to baseline levels in five to six days. 5,7-12 A diurnal rhythm has also been shown to exist, with pain levels decreasing dur ing the day and then peaking each night, although to a lower level then the previous night. 7 Although different force le vels are discernable by patients for the first few days, increased force levels10,13 have been shown not to affect pain levels. Increased severity of malocclusion has been shown not to be a significant factor either. 14 Besides pain and discomfort, orthodontic appliances have additional impacts on the daily lives of patients. Difficulties in eating, swallowing, speech and socializing have been reported with both

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9 fixed and removable appliances. 9,15-18 Patient anxiety, acceptance of and attitudes towards treatment are the most significant fa ctors contributing to these sequelae. 18,19 With the continuing growth in demand for more esthetic appliance systems such as Invisalign, it is important for orthodontists and patients to have sufficient information regarding the impacts these new appliances will have on patient s in order to support informed decisions and realistic expectations of treatment. 20 Miller11 reported that patients treated with Invisalign experience less pain and discomfort and fewer psychosocial and functional impacts than do patients treated with fixed appliances. Th is study specifically examin ed the first week of treatment, generally agreed upon in the literature to be the time period in which these impacts are the greatest. Long-term studies however are lacking. Nedwed21 reported patients adapt well to Invisalign over the first three to six months. Functional and ps ychosocial aspects over this time period diminished significantly although mild pain recurred with each new aligner in approximately half of the patients, and severe discomfort in a few. Long-term adaptation has been reported in fixed applia nce treatment as well. Sergl17 reported good adaptation to both fixed and removable appliances. A greater number of l ong-term complaints were reported in patients treated with removable appliances. The better adap tation to fixed appliances was not attributed to the appliances themselves but rather to the patients attitudes towards them. The aim of this study was to determine whether or not the benefits of Invisalign treatment over fixed appliance treatment with regards to pa in, psychosocial and functional impacts persist throughout the treatment period.

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10 CHAPTER 2 MATERIAL AND METHODS A prospective, longitudinal cohort study was completed using daily diaries (Figure 2-1) to measure the psychosocial and functional impact s of orthodontic applia nces over a seven day period, twelve to fifteen months in to treatment with Invisalign or straightwire fixed appliances. Subjects were recruited from th e private practice of an ort hodontist in Arizona and from the University of Florida Orthodontic clinics. The In stitutional Review Board of the University of Florida approved the study, and participants provided written informed consent. Subjects for the study were selected by aski ng all patients meeting the inclusion criteria over a one year period if they would like to participate at th e beginning of their regularly scheduled appointments. The inclus ion criteria were (1) Upper and lower dental arches must be treated; (2) The fixed appliances group must be treated with wires and brackets only (no quad helix, Rapid Palatal Expander (RPE), etc); (3) Must be 12 to 15 months into treatment; (4) Must be 18 years of age or older; (5 ) Must be willing to sign and gi ve written informed consent in accordance with institutional and fe deral guidelines; (6) Must be in good general health; and (7) Premolar and incisor extraction cases were acceptable. Twenty-five adult subjects ag reed to participate in the st udy and complete the one week daily diary. The diary measured impacts such as teeth soreness, soft tissue irritation, eating problems and speech impairment. Baseline data wa s taken the day of the appointment just prior to appliance adjustment or new aligner de livery. Informed consent was obtained and demographic and socioeconomic data were collecte d at the appointment as well. Subjects were asked to begin the diary on the day after their ap pointment and fill it out each day at the same time and then return it in the envelope provide d. Subjects were mailed a movie rental gift card once their diary was received. Nineteen subjects returned completed diaries, seven male and

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11 twelve female. Eight subjects were being treated with Invisalign ten were being treated with fixed appliances, and one subject was being trea ted with Invisalign in one arch and fixed appliances in the other. This pati ent was excluded from the analyses. The diary questionnaire form (Appendix A) wa s adapted from the well-validated Geriatric Oral Health Assessment Index, 22 which was developed to meas ure the psychosocial impacts of oral conditions. The daily diary questionnaire form consisted of 13 questions with ordinal responses on a Likert scale, and one pain-related question using a visual analog scale (VAS). The responses from the first 13 questions were summed to give a total impact score for each subject. The pain responses from the visual analog scale we re used to give a more exact measure of pain experienced during these seven days of therapy. The design of this study is similar to one previously reported11 which examined these factors and variables during the first week of treatment. Some but not all of the subjects in the pr esent study were particip ants in the prior study. Because of the anonymity of the study design, direct long-term comparisons for these subjects were not possible. The response variable measured was the impact of therapy as assessed with the daily diary. Factors of interest were: treatment type (Invisali gn or Fixed Appliances), time (days one through seven after fixed appliance adju stment or new aligner delivery), and initial malocclusion as accessed with the Peer Asse ssment Rating (PAR) index23 by the same calibrated investigator (A.W.C.). Subjects were not randoml y assigned to treatment groups and the examiner could not be blinded as to the treatment group because PAR sc ores were assessed on electronic casts. Casts for patients in the Invisalign treatment group were ClinCheck files whereas th e casts from the fixed appliance group were OrthoCAD files.

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12 CHAPTER 3 STATISTICAL ANALYSIS The data was input and analyzed to determine relevancy and significance. Data from the subject treated with both fixed appliances and Invisalign was omitted from the analyses. For the purposes of group characteristic comparisons non-Caucasian subject data was combined and subjects with at least some college education were analyzed together. Initial power analysis indicated an optimum sample size of one-hundred subjects, fifty per treatment group. Due to the relatively small sample size atta ined, variables were analyzed and groups compared by Fisher exact and Wilcoxon rank sum tests.

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13 CHAPTER 4 RESULTS Preliminary analysis (Tables 4-1, 4-2) show ed that the Invisalign and fixed appliance treatment groups were balanced with regard to age (Wilcoxon rank sum p=0.90), sex (Fisher exact p=0.37), ethnicity (FE p=0.66) and level of e ducation (FE p=0.64). Subjects treated with Invisalign did report higher incomes than thos e treated with fixed appliances, however these differences did not reach statistical significance (WRS p=0.13). PAR scoring of pretreatment casts revealed no significant group differences in seve rity of initial malocclusion (WRS p=0.20). No significant group differences were presen t in baseline pain as measured on a visual analog scale (VAS) or quality of life as measured by diary ques tionnaire Geriatric Oral Health Assessment Index impact scores. During the week after new aligner delivery or appliance adjustment, mean pain levels in both groups incr eased, peaking on day 1 or day 2 (Figure 4-1). Pain levels in both groups returned to baseline leve ls by day 6 or day 7. No statistically significant differences in pain levels were reported between treatment groups on any particular day during the seven day period. Two subjects (20% ) in the fixed appliances group and one subject (13%) in the Invisalign group reported using an analgesic at some point during this week. Impact scores quantifying the functional and psychosocial impa cts of orthodontic appliances in both groups dropped slightly on day 1, the day following the subjects appointments (Figure 4-2). Impact scores quickly returned to baseline levels by day 3. There were no statistic ally significant group differences in mean impacts scor es found on any day of the survey. Table 4-1. Group demographics data as re ported on the Demographics Questionnaire Age Sex Race Treatment Group Mean SE MaleFemale African American Caucasian Hispanic Asian Invisalign 30.225 3.442 2615 1 1 Braces 30.920 3.620 5525 2 1 P value p=0.90 p=0.37 p=0.66 (Caucasian vs. non-Caucasian)

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14 Table 4-2. Group socioeconomic data and mean PAR scores Education Income* Initial Malocclusion Treatment Group High school Some College College Graduate Mean SD PAR score SD Invisalign 0 5 33.751.75320.00 7.792 Braces 1 3 62.501.95824.90 9.550 P value p=0.64 (H.S. vs. College) p=0.13 p=0.20 *Income groups: 2=$10,000-24,999; 3=$25,000-49,999; 4=$50,000-74,999 0 10 20 30 40 50Ba selin e Day 1 Da y 2 Day 3 Day 4 Day 5 Da y 6 Day 7Visual Analog Scal e Invisalign Fixed Appliancesd Figure 4-1. Mean pain levels. Mean ( standard error) pain inte nsity scores for week following appliance adjustment / new aligner delivery appointment, twelve to fifteen months into treatment. Data was taken from ques tion 2 on subject daily diary questionnaires (Appendix A).

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15 45 50 55 60 65B a s e l i n e Da y 1 Day 2 Day 3 Da y 4 Day5 Day 6 Day 7Impact Score Invisalign Fixed Appliances Figure 4-2. Quality of life. Group means ( stan dard error) measured by impact scores for the week following appliance adjustment / ne w aligner delivery appointment. Scores indicate the group means from the summed component totals of question 1 on the daily diary questionnaires (Appendix A).

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16 CHAPTER 5 DISCUSSION People seeking orthodontic treatment need to know and often inquire about what to expect during treatment. Orthodontists need information at their disposal in order to help patients make informed decisions when deciding to undergo treatment and when choosing between various treatment options. Few studies have examined the functional and psychosocial impacts new orthodontic appliances such as Invisalign have on patients. In a similar study11 conducted during the first week of treatment, su bjects in the Invisalign group reported a significantly lower negative impact on daily life from day one through day seven with all p-values 0.0001. Nedwed21 reported patients adapt well to Invisalign over the durat ion of treatment. Although Invisalign appliances were not studied, Sergl17 reported good adaptation to both fixed and removable appliances. This study investigated whether or not the differences in negative impacts on patients daily lives found in a prior study persist in the long-term, throughout the dur ation of treatment. In order to attain the desired sample size of one-hundred subjects, the study design included the recruitment of twenty subjects, ten in each tr eatment group, from each of five locations around the United States. Due to lack of interest by pa tients in three of the four private orthodontic practices, subjects were enrolled in this study from only the two locations. Only six patients agreed to participate in the study from the rema ining private practice. As a result of missed appointments and discontinuation for or modifi cation with fixed appliances of the limited number of Invisalign cases at the university exte nding at least twelve mont hs, only thirty of these patients were asked to participate in the study. Despite little interest by patients in the study, nineteen patients from the Univers ity agreed to participate. Twelve of these nineteen subjects, and five of the six subjects from the priv ate practice returned completed surveys.

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17 When comparing impact scores after one year of treatment, impact scores in both treatment groups dropped slightly the day after their braces were adjusted or new aligners were delivered. Impact scores returned to baseline levels in a few days just as were the patterns during the first week of treatment as previously reported. 11 However, in this study the Invisalign group did not report significantly less negative impact th an did the fixed appliance group, indicating that long-term adaptation to appliances has eliminated any significant differences in quality of life between the two treat ment modalities. The most frequently report ed complaint and apprehension of orthodontic treatment reported in the literature is pain and discomfort. 5,6 Subjects in both treatmen t groups in this study experienced the typical pattern of pain and discom fort over the seven day study period as has been reported elsewhere pattern. 5,7-12 However, the subjects being treated with fixed appliances did not experience significantly greater pain than did those treated with Invisalign as was found during the initial week of treatme nt previously reported. 11 The results of this study suggest that, as was found with other types of removable appliances,17 patients adapt to fixed a ppliances to the extent that the benefits of Invisalign over fixed applia nces with regards to pain and discomfort do not persist throughout the duration of treatment.

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18 CHAPTER 6 CONCLUSION Based on a limited number of subjects (N=18), the results of this study suggest that while patients treated with Invisalign experience lower pain levels, psychosocial and functional impacts initially, these benefits may be limited to the begi nning of treatment and do not persist throughout the duration of treatment. Further studies are nece ssary to confirm these re sults. Orthodontists can utilize the results of this and pr ior studies to inform patients c ontemplating a decision between Invisalign and braces. Patients can be told that while their apprehensions towards braces of higher pain levels, greater psychosocial and func tional impacts are well founded, the long-term benefits of Invisalign in these respects are not long-term as they will in all likelihood adapt well to the appliances. Patients can al so expect mild transient increa ses in pain and other negative impacts with both appliances following each adjustment or new aligner.

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19 APPENDIX A DAILY DIARY QUESTIONNAIRE SUBJECT ID # _____ DATE ___-___-___ Day: __________ Instructions: Please complete the followi ng survey about how your teeth or orthodontic appliances (braces or aligners) have affected your life since your last visit. Answer only what you feel and have experienced, not what you thin k is the right answer. There are no right or wrong answers to these questions. 1. Please circle one response for each of the following questions. In the past 24 hours, how often: Always Often Sometimes Seldom Never a. did you limit the kinds or amounts of food you eat because of problems with your mouth, teeth, or orthodontic appliances? 1 2 3 4 5 b. did you have trouble biting or chewing any kinds of food, such as firm meat or apples? 1 2 3 4 5 c. were you able to swallo w comfortably? 1 2 3 4 5 d. did your teeth or orthodontic appliances prevent you from speaking the way you wanted? 1 2 3 4 5 e. were you able to eat without feeling discomfort? 1 2 3 4 5 f. did you limit contact with people because of the condition of your teeth or orthodontic appliances? 1 2 3 4 5 g. were you pleased or happy with the looks of your teeth or orthodontic appliances? 1 2 3 4 5 h. did you use medication to relieve pain or discomfort from around your mouth? 1 2 3 4 5 i. were you worried or concerned about the problems with your teeth or orthodontic appliances? 1 2 3 4 5 j. did you feel nervous or self-conscious because of problems with your teeth or orthodontic appliances? 1 2 3 4 5 k. did you feel uncomfortable eating in front of people because of problems with your teeth or orthodontic appliances? 1 2 3 4 5 l. were your teeth sensitive to hot, cold or sweets? 1 2 3 4 5 m. did your orthodontic appliances cause discomfort to your cheeks, lips, or tongue 1 2 3 4 5 Daily Diary Questionnaire. Answers from question 1 are summed to give the impact score.

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20 2. Please mark an X on the line below to i ndicate how severe your discomfort has been within the last 24 hours: ___________________________________________________________ No pain Severe Pain 3. Please indicate what time of the day you are filling out this survey: ____:____AM/PM hh mm 4. A) Have you taken any medicat ions today? Y / N (please circle) B) If so, please write in which medications you took today: ________________________________________ 5. Are you having any other problems or concer ns about your teeth or orthodontic appliances since your last orthodon tic visit? If so, please describe.

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21 LIST OF REFERENCES 1. Djeu G. Shelton C. Maganzini A. Outcome Assessment of Invisalign and traditional orthodontic treatment compar ed with American Board of Orthodontics objective grading system. American Journal of Orthodontics & Dentofacial Orthopedics 2005;128:292-8. 2. Miethke RR. Vogt S. A Comparison of th e Periodontal Health of Patients during Treatment with the Invisalign System and with Fixed Orthodontic Appliances. Journal of Orofacial Or thopedics 2005;66:219-229. 3. Lagravre MO. Flores-Mir C. The treatme nt effects of Invisalign orthodontic aligners, A systematic review. Journal of the American Dental Association 2005;136:1724-9. 4. Stewart FN, Kerr JW, Taylor P. Applia nce wear: the patients point of view. European Journal of Orthodontics 1997;19:377-382. 5. Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. American Journal of Orthodontics & Dent ofacial Orthopedics 1989;96:47-53. 6. Lew KK. Attitudes and percep tions of adults toward orthodontic treatment in an Asian community. Community Dentistry and Oral Epidemiology 1993;21:31-35. 7. Jones M, Chan C. The pain and discomfort experienced during orthodontic treatment: a randomized controlled clinical tr ial of two initial aligning arch wires. American Journal of Orthodontics & Dentofacial Orthopedics 1992;102:373-381. 8. Wilson S, Ngan P, Kess B. Time Course of discomfort in young patients undergoing orthodontic treatment. Pediat ric Dentistry 1989;11(2):107-110. 9. Scheurer P, Firestone A, Burgin W. Per ception of pain as a result of orthodontic treatment with fixed appliances. Eur opean Journal of Orthodontics 1996;18:349-357. 10. Soltis J, Nakfoor P, Bowman D. Changes in ability of patients to differentiate intensity of forces applied to maxillary cen tral incisors during orthodontic treatment. Journal of Dental Research 1971;50:590-596. 11. Miller K, McGorray S, Womack R, Quintero J, Perelmuter M, Gibson J, Dolan T, Wheeler T. A comparison of treatment imp acts between Invisalign aligner and fixed appliance therapy during the first week of treatment. American Journal of Orthodontics and Dentofacial Or thopedics 2007 131(3);302:e1-9. 12. Sergl HG, Zentner A. A comparative assessment of acceptance of different types of functional appliances. European Journal of Orthodontics 1998;20:517-524.

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22 13. Erdinc AME, Dincer B. Perception of pa in during orthodontic tr eatment with fixed appliances. European Journa l of Orthodontics 2004.26:79-85. 14. Jones ML, Richmond S. Initial tooth m ovement: force application and paina relationship? American Journal of Orthodontics & Dentofacial Orthopedics 1985;88:111-116. 15. Lewis HG, Brown WA. The attitude of patients to the wearing of a removable orthodontic appliance. Brit Dent J 1973;134:87-90. 16. Sergl HG, Klages U, Zenter A. Pain and discomfort during orthodontic treatment: Causative factors and effects on compliance. American Journal of Orthodontics and Dentofacial Orthope dics 1998;114:684-690. 17. Sergl HG, Klages U, Zentner A. Functiona l and social discomfort during orthodontic treatment-effects on compliance and predic tion of patients adaption by personality variables. European Journa l of Orthodontics 2000;22:307-315. 18. Doll GM, Zentner A, Klages U, Sergl HG. Relationship between Patient Discomfort, Appliance Acceptance and Compliance in Or thodontic Therapy. Journal of Orofacial Orthopedics 2000;61:398-413. 19. Firestone A, Scheurer P, Burgin. Patients anticipation of pain and pain-related side effects, and their perception of pain as a result of orthodontic treatment with fixed appliances. European Jour nal of Orthodontics 1999;21:387-396. 20. Wong B. Invisalign A to Z. American Journal of Orthodontics and Dentofacial Orthopedics 2002;121(5):540-541. 21. Nedwed V. Miethke RR. Motivation, Acceptance and Problems of Invisalign Patients. Journal of Orofaci al Orthopedics 2005;66:162-173. 22. Atchison K, Dolan TA. Development of the geriatric oral health assessment index. Journal of Dental Education 1990;54:680-7. 23. Richmond S, Shaw WC. The development of the PAR index (peer assessment rating): reliability and validity. European Journal of Orthodontics 1992;14:125-139.

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23 BIOGRAPHICAL SKETCH Aaron William Carroll was born on November 10, 1974 in Tallahassee, Florida. With a younger sister, he grew up in a ru ral area outside of Tallahassee, Florida, graduating from James S. Rickards High School in 1992. He earned his B.S. from the Flor ida State University (FSU) in 1997. During college and after graduation, Aaron was employed as an Information Technology Specialist by the Florida Supreme Court unt il 2000. Aaron entered dental school at the University of Florida College of Dentistry in 2000 and graduated magna cum laude in 2004, after which he began his residency in orthodon tics at the University of Florida. Upon completion of his residenc y and masters program, Aaron will enter private practice in Sarasota, Florida. Aaron was recently married to Tiffany, and they are expecting their first child in September.


Permanent Link: http://ufdc.ufl.edu/UFE0020973/00001

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Title: Long-Term Comparison of Treatment Impacts between Invisalign and Fixed Appliance Therapy
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: UFE0020973:00001

Permanent Link: http://ufdc.ufl.edu/UFE0020973/00001

Material Information

Title: Long-Term Comparison of Treatment Impacts between Invisalign and Fixed Appliance Therapy
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: UFE0020973:00001


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LONG-TERM COMPARISON OF TREATMENT IMPACTS BETWEEN INVISALIGN AND
FIXED APPLIANCE THERAPY




















By

AARON W. CARROLL


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

2007






































02007 Aaron W. Carroll









ACKNOWLEDGMENTS

I thank the chair and members of my supervisory committee for their mentoring, the staff and

members at the UF Libraries for their keen research assistance, the participants in my surveys for

their honest and open participation. I thank Dr. Randol Womack for his assistance in enrolling

participants in my study.












TABLE OF CONTENTS





ACKNOWLEDGMENTS .............. ...............3.....


LIST OF TABLES ............ ..... .__ ...............5...


LI ST OF FIGURE S .............. ...............6.....


AB S TRAC T ......_ ................. ............_........7


CHAPTER


1 INTRODUCTION .............. ...............8.....


2 MATERIAL AND METHODS ................ ...............10................


3 STATISTICAL ANALYSIS .............. ...............12....


4 RE SULT S .............. ...............13....


5 DISCUS SION ................. ...............16................


6 CONCLUSION ................. ...............18.................


APPENDIX


A DAILY DIARY QUESTIONNAIRE ................. ...............19................


LIST OF REFERENCES ................. ...............21........... ....


BIOGRAPHICAL SKETCH .............. ...............23....










LIST OF TABLES

Table page

4-1 Group demographics data .............. ...............13__. .....

4-2 Group socioeconomic data and mean PAR scores. ............. ...............14.....












LIST OF FIGURES

Figure page

4-1 Mean pain levels. ............. ...............14.....

4-2 Quality of life ........._..... ...............15._.._. .....










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

A LONG-TERM COMPARISON OF TREATMENT IMPACTS BETWEEN INVISALIGN
AND FIXED APPLIANCE THERAPY


By

Aaron W. Carroll

May 2007

Chair: Timothy Wheeler
Major: Dental Sciences

A recent study found subj ects treated with Invisalign@ appliances reported significantly

less pain and negative impact on daily life during the first week of treatment than did subjects

treated with fixed orthodontic appliances. The aim of this study was to determine if these

differences persist throughout treatment. Eighteen of twenty-five subj ects, twelve to fifteen months

into treatment at the University of Florida College of Dentistry and at a private orthodontic

practice, completed one week surveys to measure the psychosocial and pain related impact of

orthodontic treatment with either Invisalign@ or fixed appliances. There were no significant

differences found between groups with respect to age, race, education, income or severity of initial

malocclusion. Also, no significant differences in pain levels or impact on daily life between the

two groups were reported. Based on a limited number of subj ects the results of this study suggest

that the higher pain levels and greater impact on daily life experienced during the first week of

treatment by patients treated with fixed appliances compared to those treated with Invisalign@ may

not persist throughout the duration of treatment.









CHAPTER 1
INTTRODUCTION

Much of the orthodontic literature regarding orthodontic treatment with Invisalign@ is

limited to case reports, and descriptions of technique and mechanics. Few studies have compared

treatment with Invisalign@ to more traditional fixed appliances. Djeu reported Invisalign@

treatment to be less effective in occlusal and antero-posterior corrections in a retrospective study

based on a comparison of finished cases using the American Board of Orthodontics (ABO) scoring

methods. It was found that aligners were particularly effective in correcting rotations and marginal

ridge discrepancies, however. Plaque scores have been shown to be better in patients treated with

Invisalign@. 2 This was attributed to improved access for oral hygiene. Due to the weak evidence

in the literature and lack of randomized clinical trials, no strong conclusions can be made regarding

comparative treatment efficiency. 3

The orthodontic literature addressing the treatment experiences of orthodontic patients is

relatively limited. 4 Other than length of treatment, pain is the most frequent complaint during

orthodontic treatment. 5,6 This pain has been described as being more severe than the pain

experienced following dental extractions. The pain experience following initial appliance

placement or activation has been shown to follow a certain pattern, peaking at approximately 24

hours, then returning to baseline levels in five to six days. 5,7-12 A diurnal rhythm has also been

shown to exist, with pain levels decreasing during the day and then peaking each night, although

to a lower level then the previous night. Although different force levels are discernable by

patients for the first few days, increased force levelS10,13 have been shown not to affect pain

levels. Increased severity of malocclusion has been shown not to be a significant factor either. 14

Besides pain and discomfort, orthodontic appliances have additional impacts on the daily lives of

patients. Difficulties in eating, swallowing, speech and socializing have been reported with both









Eixed and removable appliances. 9,15-18 Patient anxiety, acceptance of and attitudes towards

treatment are the most significant factors contributing to these sequelae. 18,19

With the continuing growth in demand for more esthetic appliance systems such as

Invisalign@, it is important for orthodontists and patients to have sufficient information

regarding the impacts these new appliances will have on patients in order to support informed

decisions and realistic expectations of treatment. 20 Millerll reported that patients treated with

Invisalign@ experience less pain and discomfort and fewer psychosocial and functional impacts

than do patients treated with Eixed appliances. This study specifically examined the first week of

treatment, generally agreed upon in the literature to be the time period in which these impacts are

the greatest. Long-term studies however are lacking. Nedwed21 TepOrted patients adapt well to

Invisalign@ over the first three to six months. Functional and psychosocial aspects over this time

period diminished significantly although mild pain recurred with each new aligner in

approximately half of the patients, and severe discomfort in a few. Long-term adaptation has

been reported in fixed appliance treatment as well. Sergll" reported good adaptation to both fixed

and removable appliances. A greater number of long-term complaints were reported in patients

treated with removable appliances. The better adaptation to fixed appliances was not attributed to

the appliances themselves but rather to the patients' attitudes towards them.

The aim of this study was to determine whether or not the benefits of Invisalign@ treatment over

fixed appliance treatment with regards to pain, psychosocial and functional impacts persist

throughout the treatment period.









CHAPTER 2
MATERIAL AND METHODS

A prospective, longitudinal cohort study was completed using daily diaries (Figure 2-1)

to measure the psychosocial and functional impacts of orthodontic appliances over a seven day

period, twelve to fifteen months into treatment with Invisalign@ or straightwire Eixed appliances.

Subj ects were recruited from the private practice of an orthodontist in Arizona and from the

University of Florida Orthodontic clinics. The Institutional Review Board of the University of

Florida approved the study, and participants provided written informed consent.

Subj ects for the study were selected by asking all patients meeting the inclusion criteria

over a one year period if they would like to participate at the beginning of their regularly

scheduled appointments. The inclusion criteria were (1) Upper and lower dental arches must be

treated; (2) The Eixed appliances group must be treated with wires and brackets only (no quad

helix, Rapid Palatal Expander (RPE), etc); (3) Must be 12 to 15 months into treatment; (4) Must

be 18 years of age or older; (5) Must be willing to sign and give written informed consent in

accordance with institutional and federal guidelines; (6) Must be in good general health; and (7)

Premolar and incisor extraction cases were acceptable.

Twenty-Hyve adult subj ects agreed to participate in the study and complete the one week

daily diary. The diary measured impacts such as teeth soreness, soft tissue irritation, eating

problems and speech impairment. Baseline data was taken the day of the appointment just prior

to appliance adjustment or new aligner delivery. Informed consent was obtained and

demographic and socioeconomic data were collected at the appointment as well. Subj ects were

asked to begin the diary on the day after their appointment and fill it out each day at the same

time and then return it in the envelope provided. Subj ects were mailed a movie rental gift card

once their diary was received. Nineteen subjects returned completed diaries, seven male and









twelve female. Eight subj ects were being treated with Invisalign@, ten were being treated with

fixed appliances, and one subj ect was being treated with Invisalign@ in one arch and fixed

appliances in the other. This patient was excluded from the analyses.

The diary questionnaire form (Appendix A) was adapted from the well-validated Geriatric

Oral Health Assessment Index, 22 which was developed to measure the psychosocial impacts of

oral conditions. The daily diary questionnaire form consisted of 13 questions with ordinal

responses on a Likert scale, and one pain-related question using a visual analog scale (VAS). The

responses from the first 13 questions were summed to give a total 'impact score' for each subject.

The pain responses from the visual analog scale were used to give a more exact measure of pain

experienced during these seven days of therapy. The design of this study is similar to one

previously reportedly which examined these factors and variables during the first week of

treatment. Some but not all of the subj ects in the present study were participants in the prior study.

Because of the anonymity of the study design, direct long-term comparisons for these subj ects

were not possible.

The response variable measured was the impact of therapy as assessed with the daily diary.

Factors of interest were: treatment type (Invisalign@ or Fixed Appliances), time (days one through

seven after fixed appliance adjustment or new aligner delivery), and initial malocclusion as

accessed with the Peer Assessment Rating (PAR) index23 by the same calibrated investigator

(A.W.C.). Subj ects were not randomly assigned to treatment groups and the examiner could not be

blinded as to the treatment group because PAR scores were assessed on electronic casts. Casts for

patients in the Invisalign@ treatment group were ClinCheck files whereas the casts from the fixed

appliance group were OrthoCAD files.









CHAPTER 3
STATISTICAL ANALYSIS

The data was input and analyzed to determine relevancy and significance. Data from the

subject treated with both fixed appliances and Invisalign@ was omitted from the analyses. For

the purposes of group characteristic comparisons, non-Caucasian subj ect data was combined and

subjects with at least some college education were analyzed together. Initial power analysis

indicated an optimum sample size of one-hundred subj ects, fifty per treatment group. Due to the

relatively small sample size attained, variables were analyzed and groups compared by Fisher

exact and Wilcoxon rank sum tests.









CHAPTER 4
RESULTS

Preliminary analysis (Tables 4-1, 4-2) showed that the Invisalign@ and fixed appliance

treatment groups were balanced with regard to age (Wilcoxon rank sum p=0.90), sex (Fisher exact

p=0.37), ethnicity (FE p=0.66) and level of education (FE p=0.64). Subjects treated with

Invisalign@ did report higher incomes than those treated with fixed appliances, however these

differences did not reach statistical significance (WRS p=0. 13). PAR scoring of pretreatment casts

revealed no significant group differences in severity of initial malocclusion (WRS p=0.20).

No significant group differences were present in baseline pain as measured on a visual

analog scale (VAS) or quality of life as measured by diary questionnaire Geriatric Oral Health

Assessment Index impact scores. During the week after new aligner delivery or appliance

adjustment, mean pain levels in both groups increased, peaking on day 1 or day 2 (Figure 4-1).

Pain levels in both groups returned to baseline levels by day 6 or day 7. No statistically significant

differences in pain levels were reported between treatment groups on any particular day during the

seven day period. Two subjects (20%) in the fixed appliances group and one subject (13%) in the

Invisalign@ group reported using an analgesic at some point during this week. Impact scores

quantifying the functional and psychosocial impacts of orthodontic appliances in both groups

dropped slightly on day 1, the day following the subj ects' appointments (Figure 4-2). Impact scores

quickly returned to baseline levels by day 3. There were no statistically significant group

differences in mean impacts scores found on any day of the survey.

Table 4-1. Group demographics data as reported on the Demographics Questionnaire
Age Sex Race
Treatment African.
Mean SE Male Female Caucasian Hispamic Asian
Group American
Invi salign@ 30.225 3.442 2 6 1 5 1 1
Braces 30.920 3.620 5 5 2 5 2 1
P value p=0.90 p=0.37 p=0.66 (Caucasian vs. non-Caucasian)









Table 4-2. Group socioeconomic data and mean PAR scores
Education Income* Initial Malocclusion
Treatment High Some College
Mean SD PAR score SD
Group school College Graduate
Invi salign@ 0 5 3 3.75 1.753 20.00 7.792
Braces 1 3 6 2.50 1.958 24.90 9.550
P value p=0.64 (H. S. vs. College) p=0.13 p=0.20
*Income groups: 2=$10,000-24,999; 3=$25,000-49,999; 4=$50,000-74,999


50

.-40

m 30

<( 20

510


o" o;" o~"


b
0;


\c~~)
sa;~


Figure 4-1. Mean pain levels. Mean (+ standard error) pain intensity scores for week following
appliance adjustment / new aligner delivery appointment, twelve to fifteen months
into treatment. Data was taken from question 2 on subj ect daily diary questionnaires
(Appendix A).









-* Invisalign -=- Fixed Appliances


o~" o;`


~~~~"


o~"


~ce,
sa~


Figure 4-2.


Quality of life. Group means (+ standard error) measured by impact scores for the
week following appliance adjustment / new aligner delivery appointment. Scores
indicate the group means from the summed component totals of question 1 on the
daily diary questionnaires (Appendix A).









CHAPTER 5
DISCUSSION

People seeking orthodontic treatment need to know and often inquire about what to expect

during treatment. Orthodontists need information at their disposal in order to help patients make

informed decisions when deciding to undergo treatment and when choosing between various

treatment options. Few studies have examined the functional and psychosocial impacts new

orthodontic appliances such as Invisalign@ have on patients. In a similar study"l conducted during

the first week of treatment, subjects in the Invisalign@ group reported a significantly lower

negative impact on daily life from day one through day seven with all p-values I 0.0001.

Nedwed21 TepOrted patients adapt well to Invisalign@ over the duration of treatment. Although

Invisalign@ appliances were not studied, Sergll" reported good adaptation to both fixed and

removable appliances.

This study investigated whether or not the differences in negative impacts on patients'

daily lives found in a prior study persist in the long-term, throughout the duration of treatment. In

order to attain the desired sample size of one-hundred subj ects, the study design included the

recruitment of twenty subj ects, ten in each treatment group, from each of five locations around

the United States. Due to lack of interest by patients in three of the four private orthodontic

practices, subj ects were enrolled in this study from only the two locations. Only six patients

agreed to participate in the study from the remaining private practice. As a result of missed

appointments and discontinuation for or modification with fixed appliances of the limited

number of Invisalign@ cases at the university extending at least twelve months, only thirty of these

patients were asked to participate in the study. Despite little interest by patients in the study,

nineteen patients from the University agreed to participate. Twelve of these nineteen subj ects, and

five of the six subj ects from the private practice returned completed surveys.









When comparing impact scores after one year of treatment, impact scores in both

treatment groups dropped slightly the day after their braces were adjusted or new aligners were

delivered. Impact scores returned to baseline levels in a few days just as were the patterns during

the first week of treatment as previously reported. 11 However, in this study the Invisalign@ group

did not report significantly less negative impact than did the fixed appliance group, indicating that

long-term adaptation to appliances has eliminated any significant differences in quality of life

between the two treatment modalities.

The most frequently reported complaint and apprehension of orthodontic treatment

reported in the literature is pain and discomfort. 5,6 Subj ects in both treatment groups in this study

experienced the typical pattern of pain and discomfort over the seven day study period as has been

reported elsewhere pattern. 5,7-12 However, the subjects being treated with fixed appliances did not

experience significantly greater pain than did those treated with Invisalign@ as was found during

the initial week of treatment previously reported. 11 The results of this study suggest that, as was

found with other types of removable appliances," patients adapt to fixed appliances to the extent

that the benefits oflInvisalign@ over fixed appliances with regards to pain and discomfort do not

persist throughout the duration of treatment.









CHAPTER 6
CONCLUSION

Based on a limited number of subj ects (N=18), the results of this study suggest that while

patients treated with Invisalign@ experience lower pain levels, psychosocial and functional impacts

initially, these benefits may be limited to the beginning of treatment and do not persist throughout

the duration of treatment. Further studies are necessary to confirm these results. Orthodontists can

utilize the results of this and prior studies to inform patients contemplating a decision between

Invisalign@ and braces. Patients can be told that while their apprehensions towards braces of

higher pain levels, greater psychosocial and functional impacts are well founded, the long-term

benefits oflInvisalign@ in these respects are not long-term as they will in all likelihood adapt well

to the appliances. Patients can also expect mild transient increases in pain and other negative

impacts with both appliances following each adjustment or new aligner.









APPENDIX A
DAILY DIARY QUESTIONNAIRE


SUBJECT ID #


DATE


Day:


Instructions: Please complete the following survey about how your teeth or orthodontic
appliances (braces or aligners) have affected your life since your last visit. Answer only what
you feel and have experienced, not what you think is the right answer. There are no right or
wrong answers to these questions.

1. Please circle one response for each of the following questions.
In the past 24 hours, how often: Always Often Some- Seldom Never
times
a. did you limit the kinds or amounts of food
you eat because of problems with your 1 2 3 4 5
mouth, teeth, or orthodontic appliances?
b. did you have trouble biting or chewing any
kinds of food, such as firm meat or apples? 1 2 3 4 5
c. were you able to swallow comfortably? 1 2 3 4 5
d. did your teeth or orthodontic appliances
prevent you from speaking the way you 1 2 3 4 5
wanted?
e. were you able to eat without feeling 1 2 3 4 5
discomfort?
f. did you limit contact with people because of
the condition of your teeth or orthodontic 1 2 3 4 5
appliances?
g. were you pleased or happy with the looks of 1 2 3 4 5
your teeth or orthodontic appliances?
h. did you use medication to relieve pain or
discomfort from around your mouth? 1 2 3 4 5
i. were you worried or concerned about the
problems with your teeth or orthodontic 1 2 3 4 5
apliances?
j. did you feel nervous or self-conscious
because of problems with your teeth or 1 2 3 4 5
orthodontic appliances?
k. did you feel uncomfortable eating in front of
people because of problems with your teeth 1 2 3 4 5
or orthodontic appliances?
1. were your teeth sensitive to hot, cold or
1 2 3 4 5
sweets?
m. did your orthodontic appliances cause
1 2 3 4 5
discomfort to your cheeks, lips, or tongue

Daily Diary Questionnaire. Answers from question 1 are summed to give the impact score.











2. Please mark an "X" on the line below to indicate how severe your discomfort has been
within the last 24 hours:

No pain Severe Pain

3. Please indicate what time of the day you are filling out this survey: AM/PM
hh mm
4. A) Have you taken any medications today? Y / N (please circle)
B) If so, please write in which medications you took today:


5. Are you having any other problems or concerns about your teeth or orthodontic appliances
since your last orthodontic visit? If so, please describe.









LIST OF REFERENCES


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orthodontic treatment compared with American Board of Orthodontics objective
grading system. American Journal of Orthodontics & Dentofacial Orthopedics
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2. Miethke RR. Vogt S. A Comparison of the Periodontal Health of Patients during
Treatment with the Invisalign@ System and with Fixed Orthodontic Appliances.
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3. Lagravere MO. Flores-Mir C. The treatment effects of Invisalign orthodontic
aligners, A systematic review. Journal of the American Dental Association
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4. Stewart FN, Kerr JW, Taylor P. Appliance wear: the patient' s point of view.
European Journal of Orthodontics 1997; 19:3 77-3 82.

5. Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing
orthodontic treatment. American Journal of Orthodontics & Dentofacial Orthopedics
1989;96:47-53.

6. Lew KK. Attitudes and perceptions of adults toward orthodontic treatment in an
Asian community. Community Dentistry and Oral Epidemiology 1993;21:31-35.

7. Jones M, Chan C. The pain and discomfort experienced during orthodontic
treatment: a randomized controlled clinical trial of two initial aligning arch wires.
American Journal of Orthodontics & Dentofacial Orthopedics 1992; 102:3 73 -381.

8. Wilson S, Ngan P, Kess B. Time Course of discomfort in young patients undergoing
orthodontic treatment. Pediatric Dentistry 1989;11(2):107-110.

9. Scheurer P, Firestone A, Burgin W. Perception of pain as a result of orthodontic
treatment with fixed appliances. European Journal of Orthodontics 1996; 18:349-3 57.

10. Soltis J, Nakfoor P, Bowman D. Changes in ability of patients to differentiate
intensity of forces applied to maxillary central incisors during orthodontic treatment.
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11. Miller K, McGorray S, Womack R, Quintero J, Perelmuter M, Gibson J, Dolan T,
Wheeler T. A comparison of treatment impacts between Invisalign aligner and fixed
appliance therapy during the first week of treatment. American Journal of
Orthodontics and Dentofacial Orthopedics 2007 131(3);302:el-9.

12. Sergl HG, Zentner A. A comparative assessment of acceptance of different types of
functional appliances. European Journal of Orthodontics 1998;20:517-524.









13. Erdinc AME, Dincer B. Perception of pain during orthodontic treatment with fixed
appliances. European Joumnal of Orthodontics 2004.26:79-85.

14. Jones ML, Richmond S. Initial tooth movement: force application and pain- a
relationship? American Journal of Orthodontics & Dentofacial Orthopedics
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15. Lewis HG, Brown WA. The attitude of patients to the wearing of a removable
orthodontic appliance. Brit Dent J 1973;134:87-90.

16. Sergl HG, Klages U, Zenter A. Pain and discomfort during orthodontic treatment:
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17. Sergl HG, Klages U, Zentner A. Functional and social discomfort during orthodontic
treatment-effects on compliance and prediction of patient' s adaption by personality
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18. Doll GM, Zentner A, Klages U, Sergl HG. Relationship between Patient Discomfort,
Appliance Acceptance and Compliance in Orthodontic Therapy. Journal of Orofacial
Orthopedics 2000;61:398-413.

19. Firestone A, Scheurer P, Burgin. Patient' s anticipation of pain and pain-related side
effects, and their perception of pain as a result of orthodontic treatment with fixed
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20. Wong B. Invisalign@ A to Z. American Journal of Orthodontics and Dentofacial
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21. Nedwed V. Miethke RR. Motivation, Acceptance and Problems of Invisalign
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22. Atchison K, Dolan TA. Development of the geriatric oral health assessment index.
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23. Richmond S, Shaw WC. The development of the PAR index (peer assessment rating):
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BIOGRAPHICAL SKETCH

Aaron William Carroll was born on November 10, 1974 in Tallahassee, Florida. With a

younger sister, he grew up in a rural area outside of Tallahassee, Florida, graduating from James

S. Rickards High School in 1992. He earned his B.S. from the Florida State University (FSU) in

1997. During college and after graduation, Aaron was employed as an Information Technology

Specialist by the Florida Supreme Court until 2000. Aaron entered dental school at the

University of Florida College of Dentistry in 2000 and graduated magna cum laude in 2004, after

which he began his residency in orthodontics at the University of Florida.

Upon completion of his residency and master' s program, Aaron will enter private practice

in Sarasota, Florida. Aaron was recently married to Tiffany, and they are expecting their first

child in September.