Adolescent patients' experience with the Carriere distalizer appliance
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- Ruby Stanley
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1 C.F. Hamilton*, H. Saltaji**, C. B. Preston***, C. Flores-Mir****, S. Tabbaa***** Keywords Class II malocclusion; Fixed functional appliances; Orthodontics. *Private Practice, Milford, Massachusetts, USA **School of Dentistry, University of Alberta, Edmonton, Canada ***School of Dental Medicine, State University of New York at Buffalo, Buffalo, USA ****Division of Orthodontics, School of Dentistry, University of Alberta, Edmonton, Canada *****School of Dental Medicine, State University of New York at Buffalo, Buffalo, USA Adolescent patients' experience with the distalizer appliance abstract Aim To examine adolescent patients experience with the Distalizer Appliance (CDA) and compare it with that of the Fatigue Resistant Device (FFRD). Materials and methods A survey was administered to 42 patients treated with the CDA and 7 patients treated with the FFRD. Amount of time required to become accustomed to the appliance, how many patients experienced side effects as well as the degree of discomfort were explored. Results The overall experience with the device was significantly better for the CDA group than for the FFRD group. Both groups felt that delivery and removal of the appliance was quick and easy, the appliance was noticeable to some extent, and the majority became accustomed to it within two weeks with a maximum of one month. In general, associated discomfort and effects on daily life and activities were less for the CDA group than for the FFRD group. Side effects decreased over time for both groups, often more so for the CDA group. The major side effects experienced by the CDA group were difficulty eating and sore teeth, and these improved significantly over time. Soreness from the appliance rubbing on the cheek or lip was significantly less for the CDA group. Conclusion The CDA appears to be more comfortable, offers a more positive overall experience, and has fewer negative comfort-related side effects compared to FFRD. Introduction The treatment of patients with Class II malocclusions represents a significant percentage of cases treated in an orthodontic office. According to the National Health and Nutrition Estimates Survey III, 55.1% of the population aged years have a Class II malocclusion [Proffit et al., 1998]. Moreover, approximately 9% of all Class II Division 1 malocclusions have rotated maxillary molars to some degree, resulting in an increased clinical appearance of a Class II relationship [Lamons and Holmes, 1961; Henry, 1956]. Current orthodontic methods utilized for Class II correction include fixed or removable intra-maxillary appliances, fixed or removable inter-maxillary appliances, extraction protocols, and surgical repositioning techniques. A category of intermaxillary appliances frequently used in growing patients is referred to as the functional appliance (fixed or removable). Fixed functional appliances can be further divided into flexible fixed functional appliances, rigid fixed functional appliances and hybrid fixed functional appliances (e.g., the Fatigue Resistant Device, FFRD) which are a combination of both flexible and rigid forms [Ritto and Ferreira, ]. More recently the Distalizer Appliance (CDA) has been introduced with qualities similar to the flexible fixed functional appliance group [, 4]. The CDA may be used for treatment in growing and non-growing patients and has shown to be more effective in treating nonextraction Class II malocclusion cases [Rodriguez, 11]. One of the major factors for a successful orthodontic treatment is patient acceptance of the orthodontic procedures being used. Evaluation of patient experiences during orthodontic treatment will allow clinicians to better select a modality of treatment that will be best accepted by their patients. Currently, there is no published data to assess patient experiences with the CDA. Therefore, the overall goal of this study was to examine patients perception of the CDA via survey. A supplementary objective of this study was to compare current results to those of a similar survey previously developed and used by the authors to assess patients experience with the FFRD, another Class II functional appliance [Bowman et al., 12]. Clinicians using CDA or FFRD may find this information useful in preparing a patient who will be treated using either one of these devices. Materials and methods Informed consent was obtained from the participants European Journal of Paediatric Dentistry vol. 14/
2 Hamilton C.F. et al. Question P-value Q6: I was given a complete description of the appliance before wearing it Q7: When I first saw it, the appliance looked scary/ overwhelming * Q8: The appointment the was placed was quick and easy Q9: I was given instructions for wear and care of the appliance * Q: How noticeable was the (not your braces, if you have braces) to friends and family? *statistically significant, P<.5 table 1 Mean responses for Questions 6 through. Scale legend: 1=strongly dis, 2=dis, 3=neutral, 4=, 5=strongly fig. 1 Distribution of Question 7 compared to group. parents, and assent was obtained from the participants in accordance with the procedures and protocols of the University at Buffalo Children and Youth Institutional Review Board. The subjects for this study were selected from patients treated at the University at Buffalo Department of Orthodontics and two other New York private orthodontic practices. The subjects varied in age from 11 to 17 years old. Subjects older than 18 years were excluded as the content of the survey was intended for school-age patients, and to coincide with the protocol. Subjects had to have been treated or currently be treated with the CDA in order to be eligible to complete the survey. Subjects were included regardless of whether or not the appliance was unilateral or bilateral, location of the tooth pads/stainless steel arm, ethnicity, and gender. Moreover, no patient s treatment plan was modified to result in inclusion in this study. Subjects meeting the inclusion criteria were identified and asked to complete the survey. Participation was voluntary, confidential and no compensation was provided. No identifying information was included in the survey. After the child and their parents d to participate in the study, the survey was completed and the subject was asked to seal it in a provided stamped envelope and to mail it directly to the Orthodontic Department at the University at Buffalo. The survey utilized for this study was a previously developed survey by the authors to examine patients experiences with the FFRD [Bowman et al., 12]. Adjustments were made to the survey in an attempt to make questions more clear and to address the different aspects of the CDA design. At the end of the data collection period, all responses were collected by the principal investigator and subjected to statistical analysis. All statistical analyses were performed using the SPSS (IBM, Armonk, NY) for Windows. The statistical methods of comparison for the survey responses utilized the Student's t test. Results from this survey were also compared to those for the survey conducted for patients treated with the FFRD [Bowman et al., 12]. For comparisons between studies the two independent samples procedure was used, while for comparisons within a study the paired samples procedure was used. 4 dis For other categorical variables, such as sex, the Chisquare contingency table analysis was used. An alpha of.5 was considered statistically significant. Results Q7. When I first saw it, the appliance looked scary/overwhelming Dis Forty-two surveys were collected. From them, one respondent chose not to disclose his/her gender, age, and date of appliance placement. A total of 26 females and 15 males responded. There were a slightly greater percentage of female subjects than male, which was also true of the subjects in the FFRD group (58% female and 42% male). However, the difference in the ratio of females to males between groups was not statistically significant (P=.5731). The mean age was 13.9 ± 1.3 years. The results of questions 6 through for the CDA group along with the corresponding results from the FFRD group are seen in Table 1. The initial reaction to the appearance of the CDA was mostly positive (Fig. 1). Most subjects (85.3%) felt that CDA delivery was simple (Fig. 2), with a slightly greater percentage of subjects in the FFRD group responded more negatively (Table 1). All subjects felt they were given sufficient home care instructions for the CDA, with the CDA group showed a greater ment that instructions were given compared to the FFRD group. Most patients found the appliance to be somewhat or a little noticeable (Fig. 3), and results for the FFRD group were similar and no statistically significant differences were found (Table 1). 2 European Journal of Paediatric Dentistry vol. 14/3-13
3 Patient Experiences with the Appliance Q8. The appointment the appliance was placed was quick and easy Q. How noticeable was the appliance to friends and family? dis Dis Very noticeable Somewhat A little fig. 2 Distribution of Question 8 compared to group. fig. 3 Distribution of Question compared to group. Generally, subjects reported wearing rubber bands as instructed by their doctor (Fig. 4, 5). Subjects were asked to evaluate the initial effect of the CDA on numerous functions at the time of placement. Eating appeared to bear the greatest negative impact as 54.8% felt that after initial placement of the appliance eating worsened (Table 2). Mean responses for sleeping (P=.384) and appearance (P=.338) were found to be significantly more negative for the FFRD group compared to the CDA group (Table 4). Subjects were also asked to evaluate the same functions at the current time, the same day the questionnaire was completed. The majority of subjects reported functions to be the same (Table 2). When asked about the side effects, the majority of subjects were affected by the following in order of most to least affected: sore teeth, difficulty opening wide, sore jaw, difficulty keeping the appliance clean, and soreness on the lip/cheek associated with rubbing (Table 3). Also, there was a significant difference between the two appliance groups at insertion for soreness from rubbing and drooling (Table 5). At the time they completed the questionnaire, the majority of all subjects reported they were not affected by the previously described side effects at the current point in time (Table 5). The questionnaire also examined how the CDA initially may have affected daily life. Initially, % of subjects reported the appliance had no effect on school work and getting along with family and friends. For participation in music, 89.5% reported no change while.5% reported it was slightly worse. Regarding participation in sports, 97.5% reported no change while participation was slightly worse for 2.5% of subjects. A statistically significant difference was seen only for participation in sports (P=.66), indicating it was worse for the FFRD group (Table 6). Subjects were also asked to evaluate aspects of daily life at the current point in time. All subjects reported no change in schoolwork and getting along with friends. 2.4% of Question Much improved Improved Same Slightly worse Much worse Total Q13: WHEN YOU FIRST GOT THE CARRIERE compared to BEFORE you had it, how much have the following things changed? Speech (.%) 1 (2.4%) 35 (83.3%) 6 (14.3%) (.%) 42 Eating (.%) 2 (4.8%) 17 (4.5%) 19 (45.2%) 4 (9.5%) 42 Drinking (.%) 1 (2.4%) 41 (97.6%) (.%) (.%) 42 Sleeping (.%) (.%) 35 (83.3%) 6 (14.3%) 1 (2.4%) 42 Appearance 4 (9.5%) 4 (9.5%) 27 (64.3%) 6 (14.3%) 1 (2.4%) 42 I am teased 1 (2.4%) 2 (4.8%) 38 (9.5%) (.%) 1 (2.4%) 42 17: NOW, ONCE YOU ARE USED TO THE CARRIERE compared to BEFORE you had it, how much have the following things changed? Speech 1 (2.4%) 2 (4.9%) 37 (9.2%) 1 (2.4%) (.%) 41 Eating 1 (2.4%) 4 (9.8%) 32 (78.%) 4 (9.8%) (.%) 41 Drinking 1 (2.4%) (.%) 4 (97.6%) (.%) (.%) 41 Sleeping (.%) 2 (4.9%) 37 (9.2%) 2 (4.9%) (.%) 41 Appearance 3 (7.3%) 7 (17.1%) 28 (68.3%) 2 (4.9%) 1 (2.4%) 41 I am teased 1 (2.4%) 2 (4.9%) 37 (9.2%) (.%) 1 (2.4%) 41 table 2 s to questions 13 and 1. European Journal of Paediatric Dentistry vol. 14/
4 Hamilton C.F. et al. Question Not at all A little A lot Total Q14: WHEN YOU FIRST GOT THE CARRIERE compared to BEFORE you had it, how much have the following things changed? Sore teeth 3 (7.1%) 27 (64.3%) 12 (28.6%) 42 Sore jaw 15 (35.7%) (47.6%) 7 (16.7%) 42 Soreness on lip/cheek from rubbing (47.6%) 19 (45.2%) 3 (7.1%) 42 Feeling embarrassed 39 (92.9%) 2 (4.8%) 1 (2.4%) 42 Drooling 36 (85.7%) 6 (14.3%) (.%) 42 Difficult to open wide/yawn 14 (33.3%) 23 (54.8%) 5 (11.9%) 42 Keeping clean is a pain (47.6%) 18 (42.9%) 4 (9.5%) 42 18: NOW, ONCE YOU ARE USED TO THE CARRIERE compared to BEFORE you had it, how much has the following affected you? Sore teeth 26 (63.4%) 14 (34.1%) 1 (2.4%) 41 Sore jaw 32 (78%) 8 (19.5%) 1 (2.4%) 41 Soreness on lip/cheek from rubbing 28 (68.3%) 11 (26.2%) 2 (4.9%) 41 Feeling embarrassed 39 (95.1%) 1 (2.4%) 1 (2.4%) 41 Drooling 4 (97.6%) 1 (2.4%) (.%) 41 Difficult to open wide/yawn 21 (51.2%) 18 (43.9%) 2 (4.9%) 41 Keeping clean is a pain 24 (58.5%) 15 (36.6%) 2 (4.9%) 41 table 3 s to questions 14 and Q11. I wore/wear my elastic rubber bands for the amount of time instructed by my doctor 5 Q12. Wearing the elastic rubber bands is/was easy Dis dis Dis dis fig. 4 Distribution of Question 11. fig. 5 Distribution of Question 12. Question 13 Question 17 Q13/17: Mean change from initial to current time points P-value P-value P-value a. Speech change? * b. Eating change? *.66* c. Drinking change? d. Sleeping change? * *.* e. Appearance change? * * f. Being teased change? *statistically significant, P<.5 table 4 Mean responses for Questions 13 and 17, and mean change from initial to current time points. Scale legend: 1=much worse, 2=slightly worse, 3=neutral, 4=improved, 5=much improved subjects reported getting along with family improved while 97.6% reported no change. For participation in music, 97.3% reported no change while 2.7% reported it was much improved. Regarding participation in sports, 95% reported no change while for 2.5% participation was slightly worse as well as improved. However, there were no significant differences between the two appliance groups at the current time point (Table 6). Subjects were asked to evaluate their ability to become accustomed to the CDA and their opinion regarding its effect on facial appearance (Fig. 6). 94.9% of subjects reported that they had gotten used to the. Of these subjects, all reported becoming accustomed to the appliance within 4 weeks; 81.1% reported 222 European Journal of Paediatric Dentistry vol. 14/3-13
5 Patient Experiences with the Appliance Question 14 Question 18 Q14/18: Mean change from initial to current time points P-value P-value P-value a. Sore teeth? * b. Sore jaw? * c. Soreness on lip/cheek from <.1* *.24* rubbing? d. Feeling embarrassed? e. Drooling? * *.12* f. Difficulty opening wide/ * yawn? g. Keeping appliance clean? * *statistically significant, P<.5 table 5 Mean responses for Questions 14 and 18, and mean change from initial to current time points. Question 15 Question 19 Q15/19: Mean change from initial to current time points P-value P-value P-value a. School work? b. Getting along with friends? c. Getting along with family? d. Participation in music? * e. Affect participation in * sports? *statistically significant, P<.5 table 6 Mean responses for Questions 15 and 19, and mean change from initial to current time points. becoming accustomed within 2 weeks. Breakage of the CDA causing an extra visit to the orthodontist for repair was reported by 14.3% or 6 subjects. Of the subjects who required extra visits to repair the CDA, 33.3% were bothered a little while 66.7% were not bothered at all. Overall experience with the CDA was reported to be good or really good for 88.1% of subjects compared to the FFRD group who reported 57%. This difference was statistically significant (P=.7). 5 4 Q. I enjoy seeing the difference the appliance made/has been making in my facial appearance Discussion This study evaluated patient s experience with the CDA. A comparison was made between this group and a similar group of 7 subjects treated with the FFRD. The clinician who uses these devices may find this information useful in preparing a patient who will be treated using one of these devices. Since the FFRD is a more commonly used appliance than the CDA, there was a larger patient base to be utilized and the major reason the sample sizes differed for these groups. A large majority of patients felt that they were given a complete description of the appliance, the appearance of the appliance was not upsetting, placement was quick and easy, and home care instructions were adequately provided. The CDA group felt significantly less overwhelmed by the appearance of the appliance dis Dis fig. 6 Distribution of Question compared to group. than did the FFRD group, and they felt significantly more well informed regarding home care when compared to the FFRD subjects. Affording sufficient information and expectations for an appliance may contribute to a patient feeling less anxious and having a more positive experience. This may contribute to the fact that the CDA group had a significantly more positive experience overall when compared to the FFRD group. For Question, responses varied regarding how noticeable subjects felt the CDA appeared. Subjects may have had the appliance bonded to either the upper European Journal of Paediatric Dentistry vol. 14/
6 Hamilton C.F. et al. canine or upper first premolar; the latter may be assumed to be less noticeable. The position of the upper arm was not controlled for in this study and should be in future studies. Anchorage for the mandibular arch was also not a controlled variable and multiple options are available as previously described. Some subjects may have had fully bonded lower appliances and these subjects may have judged their appearance assuming this as part of the appliance; however, the letter to the patient accompanying the questionnaire specifically asked the patient to only assess the appliance and not any part of their braces. These subjects could have potentially assessed the appliance as more noticeable as opposed to a subject wearing a lower Essix or another form of anchorage. An advantage of the CDA is that it is worn in the very beginning of treatment for several months when patient compliance is at its best [, 4]. Results from this questionnaire indicate that compliance for these patients rarely appears to be cumbersome. For the FFRD group, Class II rubber bands were typically used later in treatment for some subjects prior to FFRD delivery. Approximately half (53.8%) of these subjects found wearing the appliance to be easier than wearing rubber bands; however, since subjects are typically in treatment for a significantly greater amount of time before rubber band wear compared to CDA subjects, these subjects may experience a burn out feeling toward treatment contributing to their lack of compliance. All initial limitations improved over time, and means for eating, sleeping, and appearance were found to be significantly more positive for the CDA group compared to the FFRD group at the current time point. Significant improvements for eating, speech, and sleeping were found for the CDA group. If the practitioner can anticipate those aspects of daily life that may initially be difficult for patients, an explanation to the patient may reduce anxiety and limit negative reactions. For example, informing the patient that difficulty with eating may be experienced initially, but that it generally resolves after a short time may help the patient to accommodate. Also, the practitioner may suggest the patient attempt to sleep on his or her back to limit the discomfort while sleeping initially. Appearance was found to be more negative for the FFRD group, which may sway a practitioner to use the CDA over the if they feel this will increase patient acceptance of the treatment plan. All means, except for sore teeth, were more positive for the CDA group, indicating that side effects were less burdensome, both initially and after a period of time compared to the FFRD group. These results suggest the CDA to be a more comfortable appliance with less negative side effects compared to the FFRD for these populations. The CDA appears to cause far less trauma to the soft tissue due to rubbing, which may be a deciding factor when choosing an appropriate appliance for a patient, particularly a more sensitive patient. Moreover, for the CDA group, there was a significant improvement in participation in music. Therefore, it appears that although music suffered slightly with initial appliance placement, this side effect improved with time. The amount of time for patients to become accustomed to the CDA compared to the FFRD was on average less for the CDA group. However, this was not significant and both groups essentially became accustomed within one month. Stewart et al. [1997] examined discomfort with both fixed appliances and removable appliances and found that most discomfort associated with fixed appliances resolved within four to seven days, while problems with removable appliances including speech and swallowing continued for up to three months. Accommodation to the CDA and FFRD appears to be longer than that for fixed appliances yet shorter than that for removable appliances. Additionally, breakage reported for the CDA group was significantly less than that for the group, and breakage appeared to have a more negative impact on the group when it did occur. The apparently low breakage rate, however, may be a significant benefit of the CDA as it results in less emergency chair-time, lower cost, a shorter treatment period, and greater patient satisfaction. Conclusions Initial side effects most frequently reported for the CDA group were sore teeth followed by difficulty opening. However, both groups experienced a decrease in side effects over time. Breakage of the CDA group that resulted in an extra visit to the orthodontist was significantly lower than that reported by the FFRD group. Patients experience with the CDA may be more comfortable and positive with fewer negative side effects compared to the FFRD. References Bowman AC, Saltaji H, Flores-Mir C, Preston B, Tabbaa S. Patient Experiences with the Fatigue Resistant Device. Angle Orthod 13;83(3): L. A new Class II distalizer. J Clin Orthod 4;38: Henry RG. Relationship of the maxillary first permanent molar in normal occlusion and malocclusion: An intraoral study. Am J Orthod 1956;42: Lamons FF, Holmes CW. The problem of the rotated maxillary first permanent molar. Am J Orthod 1961;47: Proffit WR, Fields HW Jr, Moray LJ. Prevalence of malocclusion and orthodontic treatment need in the United States: estimates from the NHANES III survey. Int J Adult Orthodon Orthognath Surg 1998;13:97-6. Ritto AK, Ferreira AP. Fixed functional appliances--a classification. Funct Orthod ;17: Rodriguez HL. Unilateral application of the Distalizer. J Clin Orthod 11;45: Stewart FN, Kerr WJS, Taylor PJS. Appliance wear: the patient's point of view. The European Journal of Orthodontics 1997;19: European Journal of Paediatric Dentistry vol. 14/3-13
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