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A Comparison of Treatment Impacts between Invisalign and Fixed Appliance Therapy during the First Seven Days of Treatment

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A COMPARISON OF TREATMENT IM PACTS BETWEEN INVISALIGN AND FIXED APPLIANCE THERAPY DURING THE FIRST SEVEN DAYS OF TREATMENT By KEVIN BLAINE MILLER 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 2005

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Copyright 2005 by Kevin Blaine Miller

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ACKNOWLEDGMENTS I would like to thank my wife Emily for her unconditional support throughout my years of education. To my mother and father I am grateful for always opening doors for me to pursue my goals. I would like to thank Drs. Randy Womack, Jay Gibson, and Juan Carlos Quintero for their support in recruiting and educating subjects for this study. Finally, I would like to thank Drs. Timothy Wheeler, Calogero Dolce, Sue McGorray, and Teresa Dolan for their advice and direction on this study. iii

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TABLE OF CONTENTS page ACKNOWLEDGMENTS.................................................................................................iii LIST OF TABLES...............................................................................................................v LIST OF FIGURES...........................................................................................................vi ABSTRACT......................................................................................................................vii INTRODUCTION...............................................................................................................1 MATERIALS AND METHODS.........................................................................................3 STATISTICAL ANALYSIS...............................................................................................6 RESULTS............................................................................................................................8 Sample Characteristics..................................................................................................8 Overall Impact Scores...................................................................................................8 Subcomponent Impact Scores.......................................................................................9 Visual Analog Scale Pain Reports..............................................................................10 Pain Medication..........................................................................................................11 Influence of Covariates...............................................................................................11 Archwire Size.............................................................................................................11 DISCUSSION....................................................................................................................17 CONCLUSIONS................................................................................................................22 APPENDIX: EXAMPLE OF DAILY DIARY SURVEY................................................23 LIST OF REFERENCES...................................................................................................25 BIOGRAPHICAL SKETCH.............................................................................................28 iv

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LIST OF TABLES Table page 1. Pretreatment PAR Scores................................................................................................8 2. Demographic Data........................................................................................................13 v

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LIST OF FIGURES Figure page 1. Mean overall impact scores..........................................................................................14 2. Mean functional subcomponent impact scores.............................................................14 3. Mean psychosocial subcomponent impact scores.........................................................15 4. Mean pain-related subcomponent impact scores..........................................................15 5. Mean pain scores as recorded on a visual analog scale................................................16 6. Percentage of patients in Invisalign and fixed appliance groups who took pain medication................................................................................................................16 vi

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Abstract of Thesis Pres ented to the Graduate School of the University of Florida in Partial Fulfillment of the Requirements for the Degree of Master of Science A COMPARISON OF TREATMENT IMPACTS BETWEEN INVISALIGN AND FIXED APPLIANCE THERAPY DURING THE FIRST SEVEN DAYS OF TREATMENT By Kevin Blaine Miller May 2005 Chair: Timothy Wheeler Major Department: Orthodontics The aim of this study was to evaluate the differences in quality of life impacts between patients treated with Invisalign and with fixed appliances during the first seven days of orthodontic treatment. A prospective, longitudinal study involving 60 adult orthodontic patients was completed using a daily diary to measure treatment impacts including functional, psychosocial, and pain-related outcomes. Thirty-three patients were treated with Invisalign and 27 with fixed appliances. Subjects were recruited from the University of Florida Orthodontic Clinics and four private practices located in Florida, Arizona, Kentucky, and Texas. Both overall and category-specific quality of life impacts were measured using 23 items with Likert response sets. Pain experience was assessed using a visual analog scale. A baseline survey was completed prior to the initiation of treatment; diary entries were made for seven consecutive days in order to measure various impacts of the patients orthodontic treatment over time. The baseline and diary vii

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data were then analyzed for differences between treatment modalities in terms of the patients reported impacts from their orthodontic treatment. The baseline data revealed that there were no differences between groups for baseline pain reports (p=0.42) or for overall quality of life measures (p=0.59). From day one through day seven the Invisalign group reported fewer negative impacts on their overall quality of life (p<0.001). The Invisalign group also recorded less impact in each quality of life category evaluated (functional, psycho-social, and pain-related) with p<0.0002. The visual analog scale pain reports revealed that the Invisalign group experienced less pain from day one through day seven (p<0.001). The fixed appliance group took more pain medication than the Invisalign group at days 2 and 3 (p<0.006). Adult patients treated with Invisalign experienced less pain and less negative impact on their lives during the first week of treatment. viii

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INTRODUCTION The body of literature addressing the orthodontic patients experience during treatment is relatively small. Most of the studies in this area have focused on delineating the pain experience of the orthodontic patient throughout treatment. Pain resulting from orthodontic treatment has been shown to be very significant. Jones 1 found that the pain experienced after initial archwire insertion is much greater than pain after extractions. The pain progression after initial archwire insertion is well established in the literature. The level of pain increases four hours after insertion of the initial archwire, peaks at 24 hours, and decreases to almost baseline levels at seven days. 1,2,3,4 Stewart et al 5 found that the first four to seven days after initial wire placement are the most critical for the patient in terms of general discomfort. Sergl et al 6 found that patients adapt to new appliances within seven days after appliance insertion. From these studies it can be concluded that the first seven days after archwire insertion is a crucial time for the patients adaptation to appliances and the period in which most orthodontic pain is experienced. Past studies have examined the differences in the pain response between different modalities of treatment. Stewart et al 5 observed that subjects with fixed appliances had more problems with comfort, tension, pressure, tightness, pain and sensitivity than did subjects with removable appliances. He found that the functional appliances disturbed speech and swallowing more than fixed appliances. Sergl et al 7,8 corroborated these results in two separate studies. He found that patients treated with fixed appliances 1

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2 reported more pain and discomfort than did patients wearing removable plates, while patients treated with functional or removable appliances reported more problems with impaired speech, swallowing, and feeling of oral constraint than patients treated with fixed appliances. These studies suggest that fixed appliances have more of an impact on the patients pain response during the initial stages of treatment than do removable appliances, while removable appliances have more of an effect on functional response variables such as speech and swallowing. Over the past decade Invisalign has emerged as a popular new treatment modality. The technology and fabrication process have been described elsewhere. 9 While the impact-related effects for fixed appliances have been studied, no studies have evaluated the effect of Invisalign treatment on the patient. Patients who elect to be treated with Invisalign are seeking an appliance that is less obtrusive in their everyday lives. These patients often incur a greater treatment fee in hopes that the appliance will have less negative impact on their quality of life. In order for the patient and clinician to make more informed decisions regarding treatment modality, studies are needed to evaluate the differences between Invisalign and fixed appliance therapy in their impacts on patients quality of life. To that end, the objective of this study was to evaluate the relationship between modality of treatment, Invisalign or fixed appliances, and the various quality of life effects experienced during the first seven days of orthodontic treatment.

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MATERIALS AND METHODS A prospective, longitudinal study involving 60 adult orthodontic patients was completed using a daily diary to measure the various treatment impacts. Patients accepted into the study were required to be at least 18 years of age, in good general health, and received treatment in both the upper and lower dental arches. The fixed appliances group was treated with wires and brackets only. Premolar and incisor extraction cases were acceptable. The study was approved by the Institutional Review Board, and participants completed a written informed consent form. The study sample was largely representative of adult patients seen in private orthodontic offices and consisted of 33 Invisalign patients and 27 patients treated with pre-adjusted, fixed appliances [Table 1]. Seventy-two percent of the subjects were female, with each treatment group containing similar numbers of females. Most of the subjects had at least some level of college education. Sixty-four percent of the patients used in this study were drawn from private practices located in Florida, Arizona, Kentucky and Texas. The remaining patients were drawn from the University of Florida Orthodontic Clinics. The mean pretreatment age of the Invisalign subjects was 38 years (range= 19.5-64.1) and 28 years (range= 18-53) for the fixed appliance subjects. A daily diary form [see appendix] was used to measure the effect of appliance type on the subjects quality of life. The daily diary has been shown to be a more valid instrument for recording pain than those which rely on retrospective pain memory. 10 The diary was composed three main sections: 1) 13 items measuring functional, 3

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4 psychosocial, and pain-related treatment impacts using a five-point Likert scale; 2) one pain item using a visual analog scale; 3) one item asking what (if any) pain medications were taken. Data about subjects sociodemographic characteristics were also collected. The first diary section described above was adapted from the well-validated Geriatric Oral Health Assessment Index (GOHAI) 11 which was originally designed to measure patient-reported oral function problems involving physical function, psychosocial function, pain and discomfort. The questions were modified to address impacts relevant to orthodontic treatment. The responses to the first 13 questions were combined in order to give an overall impact score for each patient at each time point. The impact score is a reflection of the patients overall reported quality of life. A higher impact score signifies fewer reported impacts while a low score signifies a negative response. These first 13 questions were also broken down into three sub-categories for analysis: 1) functional impacts (questions a, b, c, d); 2) pain-related impacts (questions e, h, l, m); and 3) psycho-social impacts (questions f, g, i, j, k). The visual analog scale was used as an additional measure of pain experience. The visual analog scale has been shown to be a valid instrument for measuring orthodontic pain. 12 Pain medication information was recorded in order to test for any possible interactions with the orthodontic treatment effect. Subjects completed a baseline, pretreatment diary form immediately before initial fixed appliances were placed or aligners were delivered. Pretreatment models and demographic data were collected at this appointment. Treatment related information such as archwire size and type (for the fixed group), whether extractions were done, and which teeth were extracted was recorded at this appointment. The patient was then sent home

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5 with a study packet which included instructions to complete identical diary forms for seven consecutive days. At the end of the seven day period the study packet was mailed back to the principal investigator in a pre-addressed envelope.

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STATISTICAL ANALYSIS Repeated measure mixed models were used to evaluate differences due to treatment group, day in treatment, baseline outcome measures, and treatment group by day interaction. The following variables were evaluated for their effect on the above mentioned models: sex, age, previous treatment, income, education and use of pain medication. The primary outcome measures evaluated in the models were overall and category-impact scores, and pain scores as recorded on a visual analog scale. Baseline demographic differences were evaluated using chi-square and Wilcoxon rank sum tests. Significance level was set at p<0.05. Standard error is illustrated in each figure. Pretreatment models were scored by the same investigator using the PAR index. 13,14 Pretreatment models were collected in order to compare the initial severity of malocclusion between the Invisalign and fixed appliance groups. One investigator was calibrated to a gold-standard for the PAR index using ten separate stone models. Once this investigator was calibrated to stone models, he then was trained in using the PAR index on Orthocad (digital) and Invisalign Clincheck (digital) models. All Invisalign patients models were in Clincheck format, while all fixed appliance patients were in stone or Orthocad format. In order to test for measurement reproducibility between formats, one investigator scored three sets of 10 identical models. One set of models was stone, one OrthoCad and one Invisalign Clincheck The reliability estimates between each format were all 0.95. These findings are in agreement with those of 6

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7 Quimby et al 15 who found the accuracy of measurements between two anatomical points on digital models to be equal to that made on stone models.

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RESULTS Sample Characteristics Pretreatment models were obtained in order to compare the groups for the severity of their initial malocclusion. As table 1 illustrates, both the Invisalign and the fixed appliance groups had a similar severity of malocclusion as rated by the PAR Index. Table 1: Pretreatment PAR Scores PAR Score Significance Invisalign 20.04 .56 NS Fixed Appliances 20.46 .67 ________________________________________________________________________ = .05 There was no significant difference between groups in gender composition, racial composition, level of education, self-reported health status or reports of prior orthodontic treatment ( Table 2 ). Although not reaching statistical significance at p=0.06, more Invisalign patients reported seeking treatment to improve my appearance, while more fixed appliance patients reported seeing treatment because my dentist referred me. The Invisalign group was significantly older and had higher incomes than the fixed appliance group. Overall Impact Scores Figure 1 illustrates the overall impact scores for the two groups during the first week of treatment. The overall pattern of impact for both groups is an initial decrease in 8

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9 quality of life followed by a return to baseline levels. The overall impact scores of the Invisalign and fixed appliance groups were not significantly different at baseline. The groups differed in their reported impact scores beginning on day 1 and continuing through day seven. At each of these time points, the fixed appliance group reported significantly lower impact scores with p<0.0001. In addition, the impact scores at each time point, independent of treatment group, are each statistically different from each other at p<0.0001. The overall impact score progression from baseline levels for each group was different. The Invisalign group reported a negative overall impact on their daily lives from day 1-3, but from days 4-7 reported an increase in quality of life compared with baseline levels. The fixed appliance group reported a drastic initial drop in quality of life at day 1. From days 2-7 the overall quality of life scores for the fixed group improved but never reached baseline levels indicating an overall negative impact for all seven days. Subcomponent Impact Scores Figure 2 Figure 3 and Figure 4 illustrate the impact scores for the two groups when the survey questions were subcategorized into functional, psycho-social, and pain-related subcomponents. For all three subcomponents, beginning at day one and extending through day seven, the Invisalign treatment group reported less negative impact than the fixed group at each time point with p<0.002. Also, the impact scores at each time point, independent of treatment group, were statistically different from each other. For the functional subcomponent (Figure 2), both groups reported a negative effect on function at day one with the fixed appliance group reporting a much more drastic drop in function. By day seven in the Invisalign groups functional impact scores had

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10 returned almost back to baseline levels, whereas the fixed appliance groups function was well below baseline levels. Analysis of the functional subcomponent questions also showed that patients baseline impact scores has an effect on their impact scores from days one through seven at a significance level of p=0.047. For the psycho-social subcomponent (Figure 3), the fixed appliance group reported a drop in psycho-social well-being on days one through three compared with baseline levels, while the Invisalign group reported an increase beginning at day one and continuing through day seven. The fixed groups psycho-social impact scores returned to baseline levels at day five and showed a slight increase at day seven. For the pain-related subcomponent (Figure 4), the fixed group reported a sharp increase in discomfort at day one and a gradual decline in discomfort from days two through seven. The fixed groups pain reports never improved to baseline levels, indicating an overall negative impact of pain for all seven days. The Invisalign group reported an increase in discomfort at days one and two, returned to baseline level at day three, and reported an improvement over baseline levels from days four through seven. Visual Analog Scale Pain Reports Figure 5 illustrates the pain reports of the two groups during the first week of treatment as recorded on a visual analog scale. At baseline there was no difference in pain reports between the groups. From days one through seven the fixed appliance patients reported significantly more pain than the Invisalign patients with p<0.0001. Independent of treatment group, the pain reports at each time point were significantly different from each other with p<0.0001. The overall pain progression is an initial increase in pain at day one followed by a gradual return to near baseline levels over days two through seven. The Invisalign groups pain level returned to baseline at day five,

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11 and decreased slightly below baseline levels at days six and seven. The fixed appliance groups pain reports do not return to baseline levels by day seven, indicating an overall negative pain experience during the first week of treatment. Pain Medication Figure 6 illustrates how the groups differed in their pain medication intake during the study period. Patients reported using only over-the-counter pain medications. Examples of medications taken were Advil, Tylenol, Ibuprofen, Motrin, and Aleve. At baseline there was no difference between the groups in pain medications reports. At day one, the difference between groups approached significance with the fixed appliance group taking more pain medication. On days two and three the fixed appliance group took more pain medication with p<0.006. From days four through seven there was no difference between the groups. Influence of Covariates The influence of the following variables were evaluated for their impact on the outcome measures: gender, age, income, education, intake of pain medication and previous orthodontic treatment. Sex, age, income and the intake of pain medication during treatment were shown to effect the overall impact score over the study period at a significance level of p<0.03. The results showed that the following characteristics were associated with lower quality of life scores during the study period: female gender, younger age, lower income and pain medication intake during the study period. Archwire Size For the fixed appliance group, the effect of the archwire size on patients overall impact scores and pain reports on the visual analog scale was evaluated. The .012 archwires were grouped with the .014 wires, and the .016 wires were grouped with the

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12 .018 wires. Forty-four percent of the archwires were .014, and 37 percent of the archwires were .016. Archwire size with material type was not evaluated since there were too many combinations of size and type for analysis. Archwire material type was not evaluated since the sample sizes of the two groups were not balanced. Sixty-seven percent of the archwires were nickel titanium, and 33 percent were copper nickel titanium. Statistics for the influence of archwire size are not shown here. These results are observational as this study was not designed to test for archwire size. The patients with smaller archwires reported less overall impact on their quality of lives beginning at day one and continuing through day seven. The shape of the curves for each group mirror each other through the entire week, with the larger archwire group reporting a lower quality of life. The pain reports as recorded on a visual analog revealed that patients with larger archwires reported higher levels of pain from day one through day five.

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13 Table 2. Demographic Data Invisalign n (%) Fixed Appliances n (%) Significance* Gender NS Male 11 (33%) 6 (22%) Female 22 (67%) 21(78%) Age (years) p=0.002 Mean SD 38.0312.40 28.189.00 Race White 24 (73%) 13 (48%) Black 1 (3%) 5 (18%) Asian 2 (6%) 1 (4%) Hispanic 5 (15%) 7 (26%) Other 1 (3%) 1 (4%) Education NS
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14 35404550556065BaselineDay 1Day2Day 3Day 4Day 5Day 6Day 7Impact Scores (Higher Values= Better) Invisalign Fixed * ** * Figure 1. Mean overall impact scores for Invisalign and fixed appliance groups. Higher impact scores on the y-axis indicate a more positive quality of life. (* p<0.05) 681012141618202224BaselineDay 1Day2Day 3Day 4Day 5Day 6Day 7Impact Score (higher values=better) Invisalign Fixed * * * Figure 2. Mean functional subcomponent impact scores for Invisalign and fixed appliance groups. (* p<0.05)

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15 681012141618202224BaselineDay 1Day2Day 3Day 4Day 5Day 6Day 7Impact Score (higher values=better) Invisalign Fixed * * * Figure 3. Mean psychosocial subcomponent impact scores for Invisalign and fixed appliance groups. (* p<0.05) 681012141618202224BaselineDay 1Day2Day 3Day 4Day 5Day 6Day 7Impact Score (higher values=better ) Invisalign Fixed * * * Figure 4. Mean pain-related subcomponent impact scores for Invisalign and fixed appliance groups. (* p<0.05)

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16 0102030405060BaselineDay 1Day2Day 3Day 4Day 5Day 6Day 7Pain Rating (higher values= more pai n) Invisalign Fixed * * * Figure 5. Mean pain scores as recorded on a visual analog scale for Invisalign and fixed appliance groups. Higher values on the y-axis indicate more pain was experienced. (* p<0.05) 01020304050607080BaselineDay 1Day 2Day3Day 4Day 5Day 6Day 7Percentage of Patients Taking Pain Meds Invisalign Fixed ** * Figure 6. Percentage of patients in Invisalign and fixed appliance groups who took pain medication. (** p=0.06, p<0.05)

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DISCUSSION This studys objective was to evaluate how appliance type, Invisalign or fixed appliances, can impact the patients quality of life during the first seven days of orthodontic treatment. A seven day diary was used to record the impact the appliance had on the patient. The patient recorded the impact of the appliance as the impact was being experienced. This daily record of impact assessment is seen as a more valid and reliable measure when compared to retrospective response data which relies on patient recall. 16 Pretreatment models were scored using the PAR index in order to compare the initial severity of malocclusion between the groups. The results revealed no significant difference between the groups in their initial malocclusion as scored using the PAR index (Table 2). An impact score was derived from the responses to the first section of the diary form. This impact score is an indication of overall quality of life. The fixed appliance group reported a significantly poorer quality of life than the Invisalign group beginning at day one and continuing through day seven. A separate measure of pain experience was recorded using a visual analog scale. The fixed appliance patients reported significantly more pain than the Invisalign group beginning at day one and continuing through day seven. Since Invisalign is a new appliance type, no studies have evaluated its impact on patients. Prior studies have looked at the impact of fixed appliances compared with removable plates. Sergl et al l6 and Steward et al 19 found that fixed appliances caused 17

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18 more discomfort for the patient than removable appliances. Sergl and Zentner 20 also found that appliances which take up minimal space in the mouth are the most readily accepted by patients. These studies are consistent with the findings of this study. The fact that Invisalign is removable likely adds substantially to the quality of life of the patient. The patient is able to remove the appliance for eating and hygiene. The small size of the Invisalign aligners and lack of sharp edges also likely adds substantially to the quality of life of the patient compared with fixed appliances. This study also found a significant time effect on the outcome measures. Patients in both groups reported a peak in impact/pain at day one followed by a decrease to near baseline levels at day seven (see Figures 1 and 5). This pain progression following the initiation of treatment is well validated in the literature for fixed appliances. 21,22,23,24 The impact/pain progression of Invisalign treatment is similar to that which has been already demonstrated for fixed appliances. From days one to seven the impact/pain progression for the Invisalign and fixed appliances were similar in that pain levels peaked at 24 hours and decreased to near baseline levels by day seven. The key difference is that at each time point the fixed appliance patients experience a more intense decrease in quality of life and a more intense increase in pain. In support of these findings, as Figure 6 shows, both groups pain medication intake peaked at day one and decreased to near baseline levels by day seven. As would be expected, pain medication intake correlated with pain report levels throughout the week. The curves in Figure 6 mirror the curves illustrated in Figure 5. Both groups took more pain medication during the first three days of treatment (when pain levels are highest), and the fixed appliance group (whose pain levels are higher) took more pain medication than the Invisalign group during the first three days.

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19 From days four through seven as both groups pain reports decreased, so did their pain medication intake. Both groups medication intake returned to near baseline levels by day seven. These findings are in agreement with Erdinc and Dincer 25 who also found a correlation between pain intensity scores and consumption of pain medication during orthodontic treatment. In addition to looking at the overall quality of life impact, the functional, psycho-social and pain-related impact of the two appliances were also evaluated (Figures 2-4). For each of these quality of life categories, from day one through day seven, the fixed appliance group reported more negative impact than the Invisalign group. These findings are agreement with prior studies. Scheurer et al 23 found that for fixed appliance patients eating is the greatest challenge to quality of daily life. Oliver and Knapman 26 found that patients report pain caused by and the appearance of fixed appliances to be the major discouraging factors during treatment. The esthetics, removability and small size of the Invisalign appliance likely account for the functional and psycho-social differences between the appliances. The pain-related category impact scores are in agreement with the pain scores recorded on the visual analog scale. The two separate outcome measures showed that the Invisalign group experienced less pain from days one through seven. The two separate measures also illustrated a similar pain progression with pain peaking at day one and gradually returning to baseline at day seven. The statistical models also suggested that the patients baseline reports in the functional category could affect future reports. A patients pretreatment functional ability could be a predictor of functional ability during treatment. Future studies using larger sample sizes could better evaluate the direction of effect the patients baseline functional

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20 reports have on future reports. In this study there was no statistical difference between the groups baseline functional impact reports, therefore any baseline effect should be equally distributed between the groups. For the fixed appliance patients, the effect of initial archwire size was also evaluated. There was a trend towards patients starting treatment with larger archwires reporting more negative impact on quality of life and more pain experienced. These results conflict with those of prior studies that found no correlation between initial archwire size and pain experience. 1,25 Since this study was not designed to evaluate archwire size effects, various combinations of archwire size and material were used on the fixed appliance patients. The inability to standardize which archwire size and material each subject received may explain why this studys findings conflict with the literature. The treatment groups in this study were not balanced for all demographic components. The treatment groups in the study differed in that the Invisalign group was older and had higher incomes than the fixed appliance group (Table 1). In addition, the statistical models used in this study suggest that female patients, younger patients and lower income patients tend to report a poorer quality of life during treatment. The weight that should be given to these covariate effects is questionable due to the small sample sizes that were used to break down the data into the various covariate groups for analysis. A larger study designed to test gender, age and income effects is needed to better evaluate these factors. No prior studies have related income to discomfort during orthodontic treatment. With respect to age, Brown and Moerenhout 17 found that adolescents, preadolescents and

PAGE 29

21 adults varied in their pain reports during orthodontic treatment. The literature is inconclusive as to how gender relates to orthodontic pain reports. 2,4,18 The two treatment groups in this study were well-balanced with respect to gender (Table 1). If age and/or income do play a role in the impact outcome measures, the results of this study could have been strengthened by more evenly distributing these variables between the groups. The difficulty in balancing the groups for income is exacerbated by the fact that the Invisalign treatment fee is often more expensive for patients due to a substantial lab fee incurred by the doctor. This higher treatment fee may explain why the Invisalign group had higher incomes and were older than the fixed appliance group. In addition, 78 percent of the Invisalign patients were drawn from a private practice setting, while only 44 percent of the fixed appliance patients came from a private practice. The remainder of the patients were drawn from a university clinic setting. The heavier weighting of private practice patients in the Invisalign group could account for the income differential between the groups. The groups also differed in their stated reason for seeking treatment. More Invisalign patients reported seeking treatment to improve my appearance, while more of the fixed appliance patients reported seeking treatment because my doctor referred me. Different motivations for treatment between the groups could influence perceived pain during treatment. If Invisalign patients are more motivated for treatment than the fixed appliance group, they may perceive the negative impacts of treatment to be small compared to the expected improvement in appearance. Sergl et al 6 found that patients with a higher internal locus of control and concern about their malocclusion perceived lower levels of pain during orthodontic treatment.

PAGE 30

CONCLUSIONS The results of this study demonstrated a significant difference between Invisalign and fixed appliance therapy in how they impact the patient during the first week of treatment. The Invisalign patients overall quality of life was much better than the fixed appliance patients during this time period. Numerous factors influence the selection of an appropriate orthodontic appliance for each patient. Both Invisalign and fixed appliances have specific indications and contraindications for use. The results of this study supply the practitioner as well as the patient with additional information that can be used when choosing appliance type. This information could also be helpful in educating patients for what to expect during their first week of treatment. The following conclusions can be made: 1. Both Invisalign and fixed appliance groups reported a decrease in quality of life after initiation of treatment. This decrease in quality of life peaked at day one and returned to near baseline levels by day seven. 2. The fixed appliance group reported a more intense decrease in overall quality of life and more a more intense increase in pain beginning at day one and extending through day seven. 3. The fixed appliance group reported a more intense decrease in functional, psycho-social and pain-related aspects of their daily lives. 4. Fixed appliance patients took more pain medication during the first three days of treatment 22

PAGE 31

APPENDIX. EXAMPLE OF DAILY DIARY SURVEY Instructions: Please complete the following survey about how your teeth or orthodontic appliances (braces or aligners) have affected your life since you started treatment. 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 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 swallow 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 anything 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 23

PAGE 32

24 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. __________________________________________________________________ __________________________________________________________________

PAGE 33

LIST OF REFERENCES 1. 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 1992; 102: 373-381. 2. Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. American Journal of Orthodontics 1989; 96: 47-53. 3. Wilson S, Ngan P, Kess B. Time course of discomfort in young patients undergoing orthodontic treatment. Pediatric Dentistry 1989; 11(2):107-110. 4. Scheurer P, Firestone A, Burgin W. Perception of pain as a result of orthodontic treatment with fixed appliances. European Journal of Orthodontics 1996; 18:349-357. 5. Stewart FN, Kerr JW, Taylor P. Appliance wear: the patients point of view. European Journal of Orthodontics 1997; 19: 377-382. 6. Sergl HG, Klages U, Zenter A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. American Journal of Orthodontics 1998; 114:684-690. 7. Sergl HG, Zentner A. A comparative assessment of acceptance of different types of functional appliances. European Journal of Orthodontics 1998; 20:517-524. 8. Sergl HG, Klages U, Zentner A. Functional and social discomfort during orthodontic treatment-effects on compliance and prediction of patients adaption by personality variables. European Journal of Orthodontics 2000; 22:307-315. 9. Wong B. Invisalign A to Z. American Journal of Orthodontics and Dentofacial Orthopedics 2002; 121(5):540-541. 10. Carp F, Carp A. The validity, reliability, and generalizability of diary data. Experimental Aging Research 1981; 7(3):281-295. 11. Atchinson K, Dolan TA. Development of the geriatric oral health assessment index. Journal of Dental Education 1990; 54: 680-687. 25

PAGE 34

26 12. Wilson S, Ngan P, Kess B. Time course of discomfort in young patients undergoing orthodontic treatment. Pediatric Dentistry 1989; 11(2):107-110. 13. Buchanan IB. The evaluation and initial testing of an index to assess orthodontic treatment standards: the PAR index. MSc Thesis, University of Manchester 1991. 14. Richmond S, Shaw WC, OBrien KD, Buchanon IB, Jones R, Stephens CD, Roberts CT, Andrews M. The development of the PAR index (Peer Assessment Rating): reliability and validity. European Journal of Orthodontics 1992; 14: 125-139. 15. Quimby M, Vig K, Rashid R, Firestone A. The accuracy and reliability of measurements made on computer-based digital models. Angle Orthodontist 2004; 74(3): 298-303. 16. Carp F, Carp A. The validity, reliability, and generalizability of diary data. Experimental Aging Research 1981; 7(3):281-295. 17. Brown FB, Moerenhout RG. The pain experience and psychological adjustment to orthodontic treatment of preadolescents, adolescents, and adults. American Journal of Orthodontics 1991; 100:349-355. 18. Jones ML. An investigation into the initial discomfort caused by placement of an archwire. European Journal of Orthodontics 1984; 6:48-54. 19. Stewart FN, Kerr JW, Taylor P. Appliance wear: the patients point of view. European Journal of Orthodontics 1997; 19: 377-382. 20. Sergl HG, Zentner A. A comparative assessment of acceptance of different types of functional appliances. European Journal of Orthodontics 1998; 20:517-524. 21. Ngan P, Kess B, Wilson S. Perception of discomfort by patients undergoing orthodontic treatment. American Journal of Orthodontics 1989; 96: 47-53. 22. Leavitt AH, King GJ, Ramsay DS, Jackson DL: A longitudinal evaluation of pulpal pain during orthodontic tooth movement. Orthodontics and Craniofacial Research 2002; 5: 29-37. 23. Scheurer P, Firestone A, Burgin W. Perception of pain as a result of orthodontic treatment with fixed appliances. European Journal of Orthodontics 1996; 18:349-357. 24. 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 1992; 102: 373-381.

PAGE 35

27 25. Erdinc A, Dincer B. Perception of pain during orthodontic treatment with fixed appliances. European Journal of Orthodontics 2004; 26(1): 79-85. 26. Oliver RG, Knapman YM. Attitudes to orthodontic treatment. British Journal of Orthodontics 1985; 12:179-18.

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BIOGRAPHICAL SKETCH Kevin Blaine Miller was born in Louisville, Kentucky, and was raised in Spartanburg, South Carolina. In 1998, he received his Bachelor of Arts degree in psychology with a minor in chemistry from Vanderbilt University in Nashville, Tennessee. He was awarded membership into Phi Beta Kappa during his final year at Vanderbilt. In 2002, he received his Doctor of Dental Medicine degree from the University of Kentucky. Dr. Miller continued his education at the University of Florida receiving his Master of Science degree with a certificate in orthodontics. 28


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Title: A Comparison of Treatment Impacts between Invisalign and Fixed Appliance Therapy during the First Seven Days of Treatment
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Copyright Date: 2008

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Material Information

Title: A Comparison of Treatment Impacts between Invisalign and Fixed Appliance Therapy during the First Seven Days of Treatment
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.
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A COMPARISON OF TREATMENT IMPACTS BETWEEN INVISALIGN AND
FIXED APPLIANCE THERAPY DURING THE FIRST SEVEN DAYS OF
TREATMENT















By

KEVIN BLAINE MILLER


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


2005





























Copyright 2005

by

Kevin Blaine Miller















ACKNOWLEDGMENTS

I would like to thank my wife Emily for her unconditional support throughout my

years of education. To my mother and father I am grateful for always opening doors for

me to pursue my goals.

I would like to thank Drs. Randy Womack, Jay Gibson, and Juan Carlos Quintero

for their support in recruiting and educating subjects for this study. Finally, I would like

to thank Drs. Timothy Wheeler, Calogero Dolce, Sue McGorray, and Teresa Dolan for

their advice and direction on this study.
















TABLE OF CONTENTS

page

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

L IST O F TA B L E S ........................................ .................................................. v

L IST O F F IG U R E S ...... ...... .......................... ........................ .. .. ...... ............ vi

ABSTRACT .............. ...................... .......... .............. vii

INTRODUCTION .............. ................................... ..............

M A TERIALS AN D M ETH OD S...................................................................................3

STA TISTICA L A N A L Y SIS ................................................................ ....................... 6

R E SU L T S ............................................................................. . 8

Sam ple C haracteristics................................................................... ....................... 8
O overall Im pact Scores........... ..... .......................................................... .. ........ ..... ..
Subcom ponent Im pact Scores.............................................................. ............... 9
Visual Analog Scale Pain Reports............................ ........... .. ...... ......... 10
Pain M education ......... ... ...... ...................... ............................ 11
Influence of C ovariates.................................................... ...... ........................ 11
A rchw ire Size ............................................................... ................ ........ 11

D IS C U S S IO N ........................................................................................ 17

C O N CLU SIO N S..... ........... ............................................................... 22

APPENDIX: EXAMPLE OF DAILY DIARY SURVEY .............................................23

L IST O F R E F E R E N C E S .......................................................................... ....................25

B IO G R A PH IC A L SK E TCH ...................................................................... ..................28









iv
















LIST OF TABLES

Table page

1. Pretreatm ent P A R Scores................................................................ ....................... 8

2. Demographic Data .............. ............. ..................... .. ........ ...... 13
















LIST OF FIGURES

Figure page

1. M ean overall im pact scores ................................................ .............................. 14

2. Mean functional subcomponent impact scores............... ................ .......... 14

3. M ean psychosocial subcomponent impact scores............................................. 15

4. M ean pain-related subcomponent impact scores ............................... ......... ......... 15

5. M ean pain scores as recorded on a visual analog scale ...... ..... .......... .................. 16

6. Percentage of patients in Invisalign and fixed appliance groups who took pain
m education ............ .......... ....... ............. ......... ............ 16















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 COMPARISON OF TREATMENT IMPACTS BETWEEN INVISALIGN AND
FIXED APPLIANCE THERAPY DURING THE FIRST SEVEN DAYS OF
TREATMENT

By

Kevin Blaine Miller

May 2005

Chair: Timothy Wheeler
Major Department: Orthodontics

The aim of this study was to evaluate the differences in quality of life impacts

between patients treated with Invisalign and with fixed appliances during the first seven

days of orthodontic treatment. A prospective, longitudinal study involving 60 adult

orthodontic patients was completed using a daily diary to measure treatment impacts

including functional, psychosocial, and pain-related outcomes. Thirty-three patients were

treated with Invisalign and 27 with fixed appliances. Subjects were recruited from the

University of Florida Orthodontic Clinics and four private practices located in Florida,

Arizona, Kentucky, and Texas. Both overall and category-specific quality of life impacts

were measured using 23 items with Likert response sets. Pain experience was assessed

using a visual analog scale. A baseline survey was completed prior to the initiation of

treatment; diary entries were made for seven consecutive days in order to measure

various impacts of the patients' orthodontic treatment over time. The baseline and diary









data were then analyzed for differences between treatment modalities in terms of the

patients' reported impacts from their orthodontic treatment. The baseline data revealed

that there were no differences between groups for baseline pain reports (p=0.42) or for

overall quality of life measures (p=0.59). From day one through day seven the Invisalign

group reported fewer negative impacts on their overall quality of life (p<0.001). The

Invisalign group also recorded less impact in each quality of life category evaluated

(functional, psycho-social, and pain-related) with p<0.0002. The visual analog scale

pain reports revealed that the Invisalign group experienced less pain from day one

through day seven (p<0.001). The fixed appliance group took more pain medication than

the Invisalign group at days 2 and 3 (p<0.006). Adult patients treated with Invisalign

experienced less pain and less negative impact on their lives during the first week of

treatment.















INTRODUCTION

The body of literature addressing the orthodontic patients' experience during

treatment is relatively small. Most of the studies in this area have focused on delineating

the pain experience of the orthodontic patient throughout treatment. Pain resulting from

orthodontic treatment has been shown to be very significant. Jones 1 found that the pain

experienced after initial archwire insertion is much greater than pain after extractions.

The pain progression after initial archwire insertion is well established in the literature.

The level of pain increases four hours after insertion of the initial archwire, peaks at 24

hours, and decreases to almost baseline levels at seven days.1'2'3,4 Stewart et a15 found

that the first four to seven days after initial wire placement are the most critical for the

patient in terms of general discomfort. Sergl et al6 found that patients adapt to new

appliances within seven days after appliance insertion. From these studies it can be

concluded that the first seven days after archwire insertion is a crucial time for the

patient's adaptation to appliances and the period in which most orthodontic pain is

experienced.

Past studies have examined the differences in the pain response between different

modalities of treatment. Stewart et a15 observed that subjects with fixed appliances had

more problems with comfort, tension, pressure, tightness, pain and sensitivity than did

subjects with removable appliances. He found that the functional appliances disturbed

speech and swallowing more than fixed appliances. Sergl et al7'8 corroborated these

results in two separate studies. He found that patients treated with fixed appliances









reported more pain and discomfort than did patients wearing removable plates, while

patients treated with functional or removable appliances reported more problems with

impaired speech, swallowing, and feeling of oral constraint than patients treated with

fixed appliances. These studies suggest that fixed appliances have more of an impact on

the patient's pain response during the initial stages of treatment than do removable

appliances, while removable appliances have more of an effect on functional response

variables such as speech and swallowing.

Over the past decade Invisalign has emerged as a popular new treatment

modality. The technology and fabrication process have been described elsewhere.9

While the impact-related effects for fixed appliances have been studied, no studies have

evaluated the effect of Invisalign treatment on the patient. Patients who elect to be

treated with Invisalign are seeking an appliance that is less obtrusive in their everyday

lives. These patients often incur a greater treatment fee in hopes that the appliance will

have less negative impact on their quality of life. In order for the patient and clinician to

make more informed decisions regarding treatment modality, studies are needed to

evaluate the differences between Invisalign and fixed appliance therapy in their impacts

on patients' quality of life.

To that end, the objective of this study was to evaluate the relationship between

modality of treatment, Invisalign or fixed appliances, and the various quality of life

effects experienced during the first seven days of orthodontic treatment.















MATERIALS AND METHODS

A prospective, longitudinal study involving 60 adult orthodontic patients was

completed using a daily diary to measure the various treatment impacts. Patients

accepted into the study were required to be at least 18 years of age, in good general

health, and received treatment in both the upper and lower dental arches. The fixed

appliances group was treated with wires and brackets only. Premolar and incisor

extraction cases were acceptable. The study was approved by the Institutional Review

Board, and participants completed a written informed consent form.

The study sample was largely representative of adult patients seen in private

orthodontic offices and consisted of 33 Invisalign patients and 27 patients treated with

pre-adjusted, fixed appliances [Table 1]. Seventy-two percent of the subjects were

female, with each treatment group containing similar numbers of females. Most of the

subjects had at least some level of college education. Sixty-four percent of the patients

used in this study were drawn from private practices located in Florida, Arizona,

Kentucky and Texas. The remaining patients were drawn from the University of Florida

Orthodontic Clinics. The mean pretreatment age of the Invisalign subjects was 38 years

(range= 19.5-64.1) and 28 years (range= 18-53) for the fixed appliance subjects.

A daily diary form [see appendix] was used to measure the effect of appliance type

on the subjects' quality of life. The daily diary has been shown to be a more valid

instrument for recording pain than those which rely on retrospective pain memory.10

The diary was composed three main sections: 1) 13 items measuring functional,









psychosocial, and pain-related treatment impacts using a five-point Likert scale; 2) one

pain item using a visual analog scale; 3) one item asking what (if any) pain medications

were taken. Data about subjects' sociodemographic characteristics were also collected.

The first diary section described above was adapted from the well-validated

Geriatric Oral Health Assessment Index (GOHAI)11 which was originally designed to

measure patient-reported oral function problems involving physical function,

psychosocial function, pain and discomfort. The questions were modified to address

impacts relevant to orthodontic treatment. The responses to the first 13 questions were

combined in order to give an overall impact score for each patient at each time point.

The impact score is a reflection of the patient's overall reported quality of life. A higher

impact score signifies fewer reported impacts while a low score signifies a negative

response. These first 13 questions were also broken down into three sub-categories for

analysis: 1) functional impacts (questions a, b, c, d); 2) pain-related impacts (questions e,

h, 1, m); and 3) psycho-social impacts (questions f, g, i, j, k). The visual analog scale

was used as an additional measure of pain experience. The visual analog scale has been

shown to be a valid instrument for measuring orthodontic pain.12 Pain medication

information was recorded in order to test for any possible interactions with the

orthodontic treatment effect.

Subjects completed a baseline, pretreatment diary form immediately before initial

fixed appliances were placed or aligners were delivered. Pretreatment models and

demographic data were collected at this appointment. Treatment related information such

as archwire size and type (for the fixed group), whether extractions were done, and which

teeth were extracted was recorded at this appointment. The patient was then sent home






5


with a study packet which included instructions to complete identical diary forms for

seven consecutive days. At the end of the seven day period the study packet was mailed

back to the principal investigator in a pre-addressed envelope.















STATISTICAL ANALYSIS

Repeated measure mixed models were used to evaluate differences due to treatment

group, day in treatment, baseline outcome measures, and treatment group by day

interaction. The following variables were evaluated for their effect on the above

mentioned models: sex, age, previous treatment, income, education and use of pain

medication. The primary outcome measures evaluated in the models were overall and

category-impact scores, and pain scores as recorded on a visual analog scale. Baseline

demographic differences were evaluated using chi-square and Wilcoxon rank sum tests.

Significance level was set at p<0.05. Standard error is illustrated in each figure.

Pretreatment models were scored by the same investigator using the PAR

index.13,14 Pretreatment models were collected in order to compare the initial severity of

malocclusion between the Invisalign and fixed appliance groups. One investigator was

calibrated to a gold-standard for the PAR index using ten separate stone models. Once

this investigator was calibrated to stone models, he then was trained in using the PAR

index on Orthocad (digital) and Invisalign Clincheck (digital) models. All Invisalign

patients' models were in Clincheck format, while all fixed appliance patients' were in

stone or Orthocad format. In order to test for measurement reproducibility between

formats, one investigator scored three sets of 10 identical models. One set of models was

stone, one OrthoCad and one Invisalign Clincheck. The reliability estimates between

each format were all > 0.95. These findings are in agreement with those of






7


Quimby et a115 who found the accuracy of measurements between two anatomical points

on digital models to be equal to that made on stone models.
















RESULTS

Sample Characteristics

Pretreatment models were obtained in order to compare the groups for the severity

of their initial malocclusion. As table 1 illustrates, both the Invisalign and the fixed

appliance groups had a similar severity of malocclusion as rated by the PAR Index.

Table 1: Pretreatment PAR Scores
PAR Score Significance

Invisalign 20.04 9.56
NS
Fixed Appliances 20.46 7.67

a= .05

There was no significant difference between groups in gender composition, racial

composition, level of education, self-reported health status or reports of prior orthodontic

treatment (Table 2). Although not reaching statistical significance at p=0.06, more

Invisalign patients reported seeking treatment 'to improve my appearance,' while more

fixed appliance patients reported seeing treatment 'because my dentist referred me.' The

Invisalign group was significantly older and had higher incomes than the fixed appliance

group.

Overall Impact Scores

Figure 1 illustrates the overall impact scores for the two groups during the first

week of treatment. The overall pattern of impact for both groups is an initial decrease in









quality of life followed by a return to baseline levels. The overall impact scores of the

Invisalign and fixed appliance groups were not significantly different at baseline. The

groups differed in their reported impact scores beginning on day 1 and continuing

through day seven. At each of these time points, the fixed appliance group reported

significantly lower impact scores with p<0.0001. In addition, the impact scores at each

time point, independent of treatment group, are each statistically different from each

other at p<0.0001.

The overall impact score progression from baseline levels for each group was

different. The Invisalign group reported a negative overall impact on their daily lives

from day 1-3, but from days 4-7 reported an increase in quality of life compared with

baseline levels. The fixed appliance group reported a drastic initial drop in quality of life

at day 1. From days 2-7 the overall quality of life scores for the fixed group improved

but never reached baseline levels indicating an overall negative impact for all seven days.

Subcomponent Impact Scores

Figure 2, Figure 3, and Figure 4 illustrate the impact scores for the two groups

when the survey questions were subcategorized into functional, psycho-social, and pain-

related subcomponents. For all three subcomponents, beginning at day one and

extending through day seven, the Invisalign treatment group reported less negative

impact than the fixed group at each time point with p<0.002. Also, the impact scores at

each time point, independent of treatment group, were statistically different from each

other.

For the functional subcomponent (Figure 2), both groups reported a negative effect

on function at day one with the fixed appliance group reporting a much more drastic drop

in function. By day seven in the Invisalign group's functional impact scores had









returned almost back to baseline levels, whereas the fixed appliance group's function was

well below baseline levels. Analysis of the functional subcomponent questions also

showed that patients' baseline impact scores has an effect on their impact scores from

days one through seven at a significance level of p=0.047.

For the psycho-social subcomponent (Figure 3), the fixed appliance group reported

a drop in psycho-social well-being on days one through three compared with baseline

levels, while the Invisalign group reported an increase beginning at day one and

continuing through day seven. The fixed group's psycho-social impact scores returned to

baseline levels at day five and showed a slight increase at day seven.

For the pain-related subcomponent (Figure 4), the fixed group reported a sharp

increase in discomfort at day one and a gradual decline in discomfort from days two

through seven. The fixed group's pain reports never improved to baseline levels,

indicating an overall negative impact of pain for all seven days. The Invisalign group

reported an increase in discomfort at days one and two, returned to baseline level at day

three, and reported an improvement over baseline levels from days four through seven.

Visual Analog Scale Pain Reports

Figure 5 illustrates the pain reports of the two groups during the first week of

treatment as recorded on a visual analog scale. At baseline there was no difference in

pain reports between the groups. From days one through seven the fixed appliance

patients reported significantly more pain than the Invisalign patients with p<0.0001.

Independent of treatment group, the pain reports at each time point were significantly

different from each other with p<0.0001. The overall pain progression is an initial

increase in pain at day one followed by a gradual return to near baseline levels over days

two through seven. The Invisalign group's pain level returned to baseline at day five,









and decreased slightly below baseline levels at days six and seven. The fixed appliance

group's pain reports do not return to baseline levels by day seven, indicating an overall

negative pain experience during the first week of treatment.

Pain Medication

Figure 6 illustrates how the groups differed in their pain medication intake during

the study period. Patients reported using only over-the-counter pain medications.

Examples of medications taken were Advil, Tylenol, Ibuprofen, Motrin, and Aleve. At

baseline there was no difference between the groups in pain medications reports. At day

one, the difference between groups approached significance with the fixed appliance

group taking more pain medication. On days two and three the fixed appliance group

took more pain medication with p<0.006. From days four through seven there was no

difference between the groups.

Influence of Covariates

The influence of the following variables were evaluated for their impact on the

outcome measures: gender, age, income, education, intake of pain medication and

previous orthodontic treatment. Sex, age, income and the intake of pain medication

during treatment were shown to effect the overall impact score over the study period at a

significance level of p<0.03. The results showed that the following characteristics were

associated with lower quality of life scores during the study period: female gender,

younger age, lower income and pain medication intake during the study period.

Archwire Size

For the fixed appliance group, the effect of the archwire size on patients' overall

impact scores and pain reports on the visual analog scale was evaluated. The .012"

archwires were grouped with the .014" wires, and the .016" wires were grouped with the









.018" wires. Forty-four percent of the archwires were .014", and 37 percent of the

archwires were .016". Archwire size with material type was not evaluated since there

were too many combinations of size and type for analysis. Archwire material type was

not evaluated since the sample sizes of the two groups were not balanced. Sixty-seven

percent of the archwires were nickel titanium, and 33 percent were copper nickel

titanium.

Statistics for the influence of archwire size are not shown here. These results are

observational as this study was not designed to test for archwire size. The patients with

smaller archwires reported less overall impact on their quality of lives beginning at day

one and continuing through day seven. The shape of the curves for each group mirror

each other through the entire week, with the larger archwire group reporting a lower

quality of life. The pain reports as recorded on a visual analog revealed that patients with

larger archwires reported higher levels of pain from day one through day five.










Table 2. Demographic Data


Gender
Male
Female


Age (years)


Race






Education





Income








Health Status


Mean SD


White
Black
Asian
Hispanic
Other


HS Graduate
Some College
College Graduate


Under $10,000
10,000-25,000
25,000-50,000
50,000-75,000
75,000-100,000
100,000+


Excellent
Very Good
Good
Fair
Poor


Reason Seeking Treatment
To improve appearance
Difficulty eating
Dental or facial pain
Dentist referral
Other


Invisalign
n (%)

11(33%)
22 (67%)


38.0312.40


24 (73%)
1 (3%)
2 (6%)
5 (15%)
1 (3%)


(0%)
(6%)
(24%)
(70%)


(6%)
(9%)
(15%)
(21%)
(9%)
(40%)


(64%)
(33%)
(3%)
(0%)
(0%)


(85%)
(0%)
(9%)
(3%)
(3%)


Previous Treatment


16 (48%)
17 (52%)


Fixed Appliances
n (%)


6 (22%)
21(78%)


28.189.00


13 (48%)
5 (18%)
1 (4%)
7 (26%)
1 (4%)


1 (4%)
2 (7%)
10 (37%)
14 (52%)


5 (19%)
4 (15%)
6 (22%)
6 (22%)
3 (11%)
3 (11%)


13 (48%)
11(41%)
3 (11%)
0 (0%)
0 (0%)


18 (67%)
0 (0%)
2 (7%)
7 (26%)
0 (0%)


9 (33%)
18 (67%)


Significance*

NS


p=0.002


NS





p=0.015








NS


NS**






NS


* a= .05
** Approached significance, p=0.06














65



60



55


50



45


Baseline Day 1 Day2 Day 3 Day 4 Day 5 Day 6 Day 7


Figure 1. Mean overall impact scores for Invisalign and fixed appliance groups. Higher
impact scores on the y-axis indicate a more positive quality of life. (* p<0.05)






24

22

20




I 16

t 14

12

10

8 -- Invisalign
-- Fixed

Baseline Day 1 Day2 Day 3 Day 4 Day 5 Day 6 Day 7






Figure 2. Mean functional subcomponent impact scores for Invisalign and fixed
appliance groups. (* p<0.05)











































Figure 3. Mean psychosocial subcomponent impact scores for Invisalign and fixed
appliance groups. (* p<0.05)


S20

18

16

14

_ 12

0 10


Baseline Day 1


Day2 Day 3 Day 4 Day 5 Day 6 Day 7


Figure 4. Mean pain-related subcomponent impact scores for Invisalign and fixed
appliance groups. (* p<0.05)


I iI

16

14

S12

10

8 -*- Invisalign
-- Fixed
Baseline Day 1 Day2 Day 3 Day 4 Day 5 Day 6 Day 7
Baseline Day 1 Day2 Day 3 Day 4 Day 5 Day 6 Day 7




















B a n Invisalign

// --, 1 --- Fixed







/ \ ^. i ----------


Figure 5. Mean pain scores as recorded on a visual analog scale for Invisalign and fixed
appliance groups. Higher values on the y-axis indicate more pain was
experienced. (* p<0.05)



80

70

60


50 -- Inisalign -

40-- -w-- Fixed--

-30




10
Ba-







Baseline Day 1 Day 2 Day3 Day 4 Day 5 Day 6 Day 7


Figure 6. Percentage of patients in Invisalign and fixed appliance groups who took pain
medication. (** p=0.06, p<0.05)


Baseline Day 1


Day2 Day 3 Day 4


Day 5 Day 6 Day 7















DISCUSSION

This study's objective was to evaluate how appliance type, Invisalign or fixed

appliances, can impact the patient's quality of life during the first seven days of

orthodontic treatment. A seven day diary was used to record the impact the appliance

had on the patient. The patient recorded the impact of the appliance as the impact was

being experienced. This daily record of impact assessment is seen as a more valid and

reliable measure when compared to retrospective response data which relies on patient

recall.16 Pretreatment models were scored using the PAR index in order to compare the

initial severity of malocclusion between the groups. The results revealed no significant

difference between the groups in their initial malocclusion as scored using the PAR index

(Table 2).

An impact score was derived from the responses to the first section of the diary

form. This impact score is an indication of overall quality of life. The fixed appliance

group reported a significantly poorer quality of life than the Invisalign group beginning at

day one and continuing through day seven. A separate measure of pain experience was

recorded using a visual analog scale. The fixed appliance patients reported significantly

more pain than the Invisalign group beginning at day one and continuing through day

seven.

Since Invisalign is a new appliance type, no studies have evaluated its impact on

patients. Prior studies have looked at the impact of fixed appliances compared with

removable plates. Sergl et al16 and Steward et a119 found that fixed appliances caused









more discomfort for the patient than removable appliances. Sergl and Zentner20 also

found that appliances which take up minimal space in the mouth are the most readily

accepted by patients. These studies are consistent with the findings of this study. The

fact that Invisalign is removable likely adds substantially to the quality of life of the

patient. The patient is able to remove the appliance for eating and hygiene. The small

size of the Invisalign aligners and lack of sharp edges also likely adds substantially to the

quality of life of the patient compared with fixed appliances.

This study also found a significant time effect on the outcome measures. Patients

in both groups reported a peak in impact/pain at day one followed by a decrease to near

baseline levels at day seven (see Figures 1 and 5). This pain progression following the

initiation of treatment is well validated in the literature for fixed appliances.21'22'23'24 The

impact/pain progression of Invisalign treatment is similar to that which has been already

demonstrated for fixed appliances. From days one to seven the impact/pain progression

for the Invisalign and fixed appliances were similar in that pain levels peaked at 24 hours

and decreased to near baseline levels by day seven. The key difference is that at each

time point the fixed appliance patients experience a more intense decrease in quality of

life and a more intense increase in pain. In support of these findings, as Figure 6 shows,

both groups' pain medication intake peaked at day one and decreased to near baseline

levels by day seven. As would be expected, pain medication intake correlated with pain

report levels throughout the week. The curves in Figure 6 mirror the curves illustrated in

Figure 5. Both groups took more pain medication during the first three days of treatment

(when pain levels are highest), and the fixed appliance group (whose pain levels are

higher) took more pain medication than the Invisalign group during the first three days.









From days four through seven as both groups pain reports decreased, so did their pain

medication intake. Both groups' medication intake returned to near baseline levels by

day seven. These findings are in agreement with Erdinc and Dincer25 who also found a

correlation between pain intensity scores and consumption of pain medication during

orthodontic treatment.

In addition to looking at the overall quality of life impact, the functional, psycho-

social and pain-related impact of the two appliances were also evaluated (Figures 2-4).

For each of these quality of life categories, from day one through day seven, the fixed

appliance group reported more negative impact than the Invisalign group. These findings

are agreement with prior studies. Scheurer et a123 found that for fixed appliance patients

eating is the greatest challenge to quality of daily life. Oliver and Knapman26 found that

patients report pain caused by and the appearance of fixed appliances to be the major

discouraging factors during treatment. The esthetics, removability and small size of the

Invisalign appliance likely account for the functional and psycho-social differences

between the appliances. The pain-related category impact scores are in agreement with

the pain scores recorded on the visual analog scale. The two separate outcome measures

showed that the Invisalign group experienced less pain from days one through seven.

The two separate measures also illustrated a similar pain progression with pain peaking at

day one and gradually returning to baseline at day seven.

The statistical models also suggested that the patient's baseline reports in the

functional category could affect future reports. A patient's pretreatment functional ability

could be a predictor of functional ability during treatment. Future studies using larger

sample sizes could better evaluate the direction of effect the patient's baseline functional









reports have on future reports. In this study there was no statistical difference between

the groups' baseline functional impact reports, therefore any baseline effect should be

equally distributed between the groups.

For the fixed appliance patients, the effect of initial archwire size was also

evaluated. There was a trend towards patients starting treatment with larger archwires

reporting more negative impact on quality of life and more pain experienced. These

results conflict with those of prior studies that found no correlation between initial

archwire size and pain experience.1'25 Since this study was not designed to evaluate

archwire size effects, various combinations of archwire size and material were used on

the fixed appliance patients. The inability to standardize which archwire size and

material each subject received may explain why this study's findings conflict with the

literature.

The treatment groups in this study were not balanced for all demographic

components. The treatment groups in the study differed in that the Invisalign group was

older and had higher incomes than the fixed appliance group (Table 1). In addition, the

statistical models used in this study suggest that female patients, younger patients and

lower income patients tend to report a poorer quality of life during treatment. The weight

that should be given to these covariate effects is questionable due to the small sample

sizes that were used to break down the data into the various covariate groups for analysis.

A larger study designed to test gender, age and income effects is needed to better evaluate

these factors.

No prior studies have related income to discomfort during orthodontic treatment.

With respect to age, Brown and Moerenhout17 found that adolescents, preadolescents and









adults varied in their pain reports during orthodontic treatment. The literature is

inconclusive as to how gender relates to orthodontic pain reports.2'4'18 The two treatment

groups in this study were well-balanced with respect to gender (Table 1). If age and/or

income do play a role in the impact outcome measures, the results of this study could

have been strengthened by more evenly distributing these variables between the groups.

The difficulty in balancing the groups for income is exacerbated by the fact that the

Invisalign treatment fee is often more expensive for patients due to a substantial lab fee

incurred by the doctor. This higher treatment fee may explain why the Invisalign group

had higher incomes and were older than the fixed appliance group. In addition, 78

percent of the Invisalign patients were drawn from a private practice setting, while only

44 percent of the fixed appliance patients came from a private practice. The remainder of

the patients were drawn from a university clinic setting. The heavier weighting of private

practice patients in the Invisalign group could account for the income differential

between the groups.

The groups also differed in their stated reason for seeking treatment. More

Invisalign patients reported seeking treatment to "improve my appearance," while more

of the fixed appliance patients reported seeking treatment "because my doctor referred

me." Different motivations for treatment between the groups could influence perceived

pain during treatment. If Invisalign patients are more motivated for treatment than the

fixed appliance group, they may perceive the negative impacts of treatment to be small

compared to the expected improvement in appearance. Sergl et al6 found that patients

with a higher internal locus of control and concern about their malocclusion perceived

lower levels of pain during orthodontic treatment.















CONCLUSIONS

The results of this study demonstrated a significant difference between Invisalign

and fixed appliance therapy in how they impact the patient during the first week of

treatment. The Invisalign patients' overall quality of life was much better than the fixed

appliance patients during this time period. Numerous factors influence the selection of an

appropriate orthodontic appliance for each patient. Both Invisalign and fixed appliances

have specific indications and contraindications for use. The results of this study supply

the practitioner as well as the patient with additional information that can be used when

choosing appliance type. This information could also be helpful in educating patients for

what to expect during their first week of treatment.

The following conclusions can be made:

1. Both Invisalign and fixed appliance groups reported a decrease in quality of

life after initiation of treatment. This decrease in quality of life peaked at

day one and returned to near baseline levels by day seven.

2. The fixed appliance group reported a more intense decrease in overall

quality of life and more a more intense increase in pain beginning at day

one and extending through day seven.

3. The fixed appliance group reported a more intense decrease in functional,

psycho-social and pain-related aspects of their daily lives.

4. Fixed appliance patients took more pain medication during the first three

days of treatment
















APPENDIX. EXAMPLE OF DAILY DIARY SURVEY

Instructions: Please complete the following survey about how your teeth or orthodontic appliances
(braces or aligners) have affected your life since you started treatment. 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:
a. did you limit the kinds or amounts of food
you eat because of problems with your
mouth, teeth, or orthodontic appliances?
b. did you have trouble biting or chewing any
kinds of food, such as firm meat or apples?
c. were you able to swallow comfortably?
d. did your teeth or orthodontic appliances
prevent you from speaking the way you
wanted?
e. were you able to eat anything without feeling
discomfort?
f did you limit contact with people because of
the condition of your teeth or orthodontic
appliances?
g. were you pleased or happy with the looks of
your teeth or orthodontic appliances?
h. did you use medication to relieve pain or
discomfort from around your mouth?
i. were you worried or concerned about the
problems with your teeth or orthodontic
appliances?
j. did you feel nervous or self-conscious
because of problems with your teeth or
orthodontic appliances?
k. did you feel uncomfortable eating in front of
people because of problems with your teeth
or orthodontic appliances?
1. were your teeth sensitive to hot, cold, or
sweets?

m. did your orthodontic appliances cause
discomfort to your cheeks, lips, or tongue


Always Often Some-
times


Seldom Never


1 2 3 4 5


1 2 3 4 5

1 2 3 4 5


1 2 3 4 5

1 2 3 4 5


1 2 3 4 5

1 2 3 4 5


1 2 3 4 5


1 2 3 4 5


1 2 3 4 5


1 2 3 4 5









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


1. 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 1992; 102: 373-381.

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

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

4. 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-
357.

5. Stewart FN, Kerr JW, Taylor P. Appliance wear: the patient's point of view.
European Journal of Orthodontics 1997; 19: 377-382.

6. Sergl HG, Klages U, Zenter A. Pain and discomfort during orthodontic treatment:
causative factors and effects on compliance. American Journal of Orthodontics
1998; 114:684-690.

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

8. Sergl HG, Klages U, Zentner A. Functional and social discomfort during
orthodontic treatment-effects on compliance and prediction of patient's adaption
by personality variables. European Journal of Orthodontics 2000; 22:307-315.

9. Wong B. Invisalign A to Z. American Journal of Orthodontics and Dentofacial
Orthopedics 2002; 121(5):540-541.

10. Carp F, Carp A. The validity, reliability, and generalizability of diary data.
Experimental Aging Research 1981; 7(3):281-295.

11. Atchinson K, Dolan TA. Development of the geriatric oral health assessment
index. Journal of Dental Education 1990; 54: 680-687.









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

13. Buchanan IB. The evaluation and initial testing of an index to assess orthodontic
treatment standards: the PAR index. MSc Thesis, University of Manchester 1991.

14. Richmond S, Shaw WC, O'Brien KD, Buchanon IB, Jones R, Stephens CD,
Roberts CT, Andrews M. The development of the PAR index (Peer Assessment
Rating): reliability and validity. European Journal of Orthodontics 1992; 14: 125-
139.

15. Quimby M, Vig K, Rashid R, Firestone A. The accuracy and reliability of
measurements made on computer-based digital models. Angle Orthodontist 2004;
74(3): 298-303.

16. Carp F, Carp A. The validity, reliability, and generalizability of diary data.
Experimental Aging Research 1981; 7(3):281-295.

17. Brown FB, Moerenhout RG. The pain experience and psychological adjustment
to orthodontic treatment of preadolescents, adolescents, and adults. American
Journal of Orthodontics 1991; 100:349-355.

18. Jones ML. An investigation into the initial discomfort caused by placement of an
archwire. European Journal of Orthodontics 1984; 6:48-54.

19. Stewart FN, Kerr JW, Taylor P. Appliance wear: the patient's point of view.
European Journal of Orthodontics 1997; 19: 377-382.

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

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

22. Leavitt AH, King GJ, Ramsay DS, Jackson DL: A longitudinal evaluation of
pulpal pain during orthodontic tooth movement. Orthodontics and Craniofacial
Research 2002; 5: 29-37.

23. 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-
357.

24. 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 1992; 102: 373-381.






27


25. Erdinc A, Dincer B. Perception of pain during orthodontic treatment with fixed
appliances. European Journal of Orthodontics 2004; 26(1): 79-85.

26. Oliver RG, Knapman YM. Attitudes to orthodontic treatment. British Journal of
Orthodontics 1985; 12:179-18.















BIOGRAPHICAL SKETCH

Kevin Blaine Miller was born in Louisville, Kentucky, and was raised in

Spartanburg, South Carolina. In 1998, he received his Bachelor of Arts degree in

psychology with a minor in chemistry from Vanderbilt University in Nashville,

Tennessee. He was awarded membership into Phi Beta Kappa during his final year at

Vanderbilt. In 2002, he received his Doctor of Dental Medicine degree from the

University of Kentucky. Dr. Miller continued his education at the University of Florida

receiving his Master of Science degree with a certificate in orthodontics.