RANDOMIZED CONTROLLED TRIAL
Assessment of the changes in arch perimeter and irregularity in the mandibular arch during initial alignment with the AcceleDent Aura appliance vs no appliance in adolescents: A single-blind randomized clinical trial Peter Milesa and Elizabeth Fisherb Caloundra and Brisbane, Queensland, Australia Introduction: The purpose of this 2-arm parallel trial was to assess the effects of the AcceleDent Aura (OrthoAccel Technologies, Houston, Tex) appliance on the increase in mandibular anterior arch perimeter, the reduction in mandibular arch irregularity, and the amount of discomfort during initial alignment of the mandibular arch with fixed appliances. Methods: Forty Class II adolescent patients with full fixed appliances and treated with maxillary premolar extractions and no extractions in the mandibular arch participated in this randomized clinical trial. They were recruited in a private practice and treated by 1 clinician. Randomization to either a no-appliance group or the AcceleDent Aura appliance group was accomplished with permuted blocks of 10 patients with the allocations concealed in opaque, sealed envelopes. Both the operator and the outcome assessor were blinded, but it was not feasible to blind the patients. Discomfort was recorded during the first week of treatment. Mandibular anterior arch perimeter and anterior irregularity were measured from plaster models taken at the start of treatment and after 5, 8, and 10 weeks. Results: No patients were lost to followup, and no data were missing. There was no difference in anterior arch perimeter at the start of treatment (P 5 0.85; median, 0.6 mm; 95% confidence interval [CI], 1.6, 11.8 mm) or at any other time point (5 weeks: P 5 0.84; median, 0.2 mm; 95% CI, 1.6, 11.2 mm; 8 weeks: P 5 0.56; median, 0.3 mm; 95% CI, 1.6, 10.7 mm; 10 weeks: P 5 0.67; median, 0.1 mm; 95% CI, 1.5, 11.1 mm). There was also no difference between groups for incisor irregularity (P 5 0.46; median, 0.5 mm; 95% CI, 2.2, 12.8 mm; P 5 0.80; median, 0.0 mm; 95% CI, 1.0, 11.1 mm; P 5 0.70; median, 0.1 mm; 95% CI, 0.7, 10.8 mm; P 5 0.65; median, 0.2 mm; 95% CI, 0.6, 10.6 mm). No difference was detected at any time during the first week for discomfort (baseline: P 5 0.84; median, 1.5 mm; 95% CI, 15.9, 19.8 mm; 6 hours: P 5 0.96; median, 0.3 mm; 95% CI, 23.5, 121.8 mm; 1 day: P, 0.75; median, 3.5 mm; 95% CI, 27.1, 126.9 mm; 3 days: P 5 0.98; median, 0.6 mm; 95% CI, 20.6, 120.0; 7 days: P 5 0.57; median, 0.5 mm; 95% CI, 5.0, 15.3 mm). However, significantly fewer participants in the AcceleDent Aura group used analgesics at day 1 (P 5 \0.01). Conclusions: The AcceleDent Aura appliance had no effect compared with no appliance on increasing anterior arch perimeter, or reducing irregularity or perceived discomfort during initial alignment with fixed appliances, although more subjects used painkillers at 24 hours in the no-appliance group. Registration: This trial was not registered. Protocol: The protocol was not published before trial commencement. Funding: A special research grant was obtained from the Australian Society of Orthodontists Foundation for Research and Education to purchase the AcceleDent Aura appliances and fund the statistical analysis. (Am J Orthod Dentofacial Orthop 2016;150:928-36)
a
Private practice, Caloundra, Queensland, Australia. Private practice, Brisbane, Queensland, Australia. All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest, and none were reported. Address correspondence to: Peter Miles, 10 Mayes Ave, Caloundra, QLD 4551, Australia; e-mail,
[email protected]. b
928
Submitted, January 2016; revised and accepted, July 2016. 0889-5406/$36.00 Ó 2016 by the American Association of Orthodontists. All rights reserved. http://dx.doi.org/10.1016/j.ajodo.2016.07.016
Miles and Fisher
W
ith the risks of orthodontic treatment such as root resorption and demineralization, it is not surprising that clinicians are looking for ways to decrease orthodontic treatment times to reduce these risks for their patients. Treatment times can vary widely but often involve 2 or more years in fixed appliances.1,2 However, with patients wanting significantly shorter treatments of only 6 to 12 months, this places significant pressure on orthodontic providers and companies to find ways to accelerate treatment.3 Treatment time depends on the rate of tooth movement, which in turn depends on the rate of alveolar remodeling. Therefore, it may be possible to increase the rate of tooth movement by accelerating the biologic response of the periodontal ligament and alveolar bone.4 Although the exact mechanism of alveolar remodeling is not completely understood, there are 2 main hypotheses: (1) piezoelectricity generated within the alveolar bone, and (2) pressure-tension within the periodontal ligament.5 With piezoelectricity, orthodontic forces bending alveolar bone generate an electrical charge that in turn induces an osteogenic response.6 Shapiro et al7 suggested that these orthodontic forces should not be continuous, since the piezoelectric charges are created only when stress is applied and released. A vibrational appliance may therefore be suitable for initiating these stress-induced charges because forces could be applied and released at a rapid rate. Early research involving vibrational appliances and orthodontic tooth movement in animal models demonstrated promising results.8-10 With Wistar rats, approximately 15% more tooth movement was achieved in 21 days using resonance vibration for 8 minutes per day (on days 0, 7, and 14), when compared with a control group with only static forces.9 Vibrational force applied to Macaca fuscata monkeys for 1.5 hours per day over 3 weeks was reported to be 1.3 to 1.4 times faster (about 25%-30%) than loading a static force.10 This could be considered clinically significant if it is found in humans. In a case report involving a pulsating force with headgear, greater movement of the pulsed tooth was reported when compared with the control tooth.7 The authors of a later case series stated that they achieved “promising rates of tooth movement” by having patients use a vibrational appliance for 20 minutes per day.11 Another study reported 2 to 3 mm of movement per month in both arches by measuring the reduction in Little's irregularity index.12 However, these studies had low-quality evidence because they lacked control groups and had only small sample sizes. A retrospective study examining the rate of leveling and alignment in the mandibular arch of nonextraction subjects reported a
929
30% increase in the rate of movement using the AcceleDent (OrthoAccel Technologies, Houston, Tex) appliance (30 Hz; 0.2 N, or about 20 g).13 However, the lack of blinding and the retrospective nature of the study meant that the results should be interpreted with caution. In contrast, a prospective randomized clinical trial (RCT) using the Tooth Masseuse appliance (111 Hz; 0.06 N, or about 6 g) reported no difference in the rate of mandibular arch initial alignment in nonextraction subjects or in their reported discomfort.14 More recently, an RCT compared the use of the AcceleDent appliance during initial alignment with fixed appliances in the mandibular arch of patients having mandibular premolar extractions.15 The authors found no evidence that vibration increased the rate of tooth movement or reduced the time required to achieve final alignment. Therefore, there seems to be some disagreement about any effect of vibration between the previous retrospective trials and the prospective RCTs. See Supplemental Materials for a short video presentation about this study. SPECIFIC OBJECTIVES OR HYPOTHESES
The primary purpose of this study was to assess the amount of tooth movement by measuring the anterior arch perimeter and irregularity index during initial alignment in the mandibular arch when using the AcceleDent Aura appliance (OrthoAccel Technologies) in adolescent orthodontic patients. A secondary outcome was to assess the amount of discomfort and the use of analgesics during the first week of treatment. The null hypothesis was that the AcceleDent Aura appliance does not increase the rate of movement as measured by the irregularity index or the anterior arch perimeter in the mandibular arch or decrease pain during initial alignment. MATERIAL AND METHODS Trial design and any changes after trial commencement
This was a single-center, randomized clinical trial with a 1:1 allocation. No changes occurred during the trial. Participants, eligibility criteria, and settings
Ethical approval was obtained from the University of Queensland Dental Sciences Research Ethics Committee (project number 1315), Brisbane, Australia, and written informed consent was obtained from all patients and parents. A special research grant was obtained from the Australian Society of Orthodontists Foundation for Research and Education to purchase the AcceleDent Aura appliances and to fund the statistical analysis. Patients who met the selection criteria were prospectively recruited from the private orthodontic clinic of the first
American Journal of Orthodontics and Dentofacial Orthopedics
December 2016 Vol 150 Issue 6
Miles and Fisher
930
author (P.M.). Eligibility for inclusion consisted of (1) children up to age 16, (2) a fully erupted dentition from first molar forward, (3) erupted or erupting second molars, (4) no missing or previously extracted permanent teeth, (5) undergoing comprehensive orthodontic treatment with full fixed appliances, and (6) a Class II malocclusion requiring extraction of 2 maxillary premolars but no mandibular extractions.
Alginate impressions of the mandibular anterior teeth were taken at 4 time points: at the start of treatment and at 5, 8, and 10 weeks to allow for comparisons of the amount of movement over the study period.14 The initial archwire was retied at the 5-week appointment, but no adjustment or retying was undertaken at 8 weeks. Identification numbers were assigned to the models before measurement to ensure blinding of the model assessor.
Sample size calculation
A power analysis based on the arch perimeter data from an unpublished study from the University of Texas Health Science Center at San Antonio (means, 1.32 mm per week [SD, 1] vs 2.71 mm per week [SD, 1.42]) indicated that a sample size of 17 subjects per group (n 5 34) would be required to have 90% power at P 5 0.05.16 We decided to enroll 20 subjects per group (n 5 40) to allow for approximately 10% dropouts from the study sample. Randomization (random number generation, allocation concealment, implementation)
Randomization was performed using permuted blocks of 10 randomly generated numbers with the random generation function in Excel (Microsoft, Redmond, Wash); the numbers were sealed in opaque envelopes and shuffled by a staff member. A clinical assistant opened an envelope for the group assignment after a patient's brackets were bonded and gave routine instructions in a closed consultation room to ensure that the operator (P.M.) was blinded. Blinding
Patients were aware of their treatment group. The operator was blinded to the group assignment, and the model assessor (E.F.) was blinded to the treatment group and the model time point. Interventions
Each eligible patient was randomly assigned to either a group using the AcceleDent Aura appliance for 20 minutes per day or a group that received no appliance. All patients were indirectly bonded with conventional 0.018-in slot, MBT prescription brackets (Victory Series; 3M Unitek, Monrovia, Calif) on all mandibular teeth and the maxillary premolars and molars, whereas the maxillary incisors and canines were bonded with MBT equivalent prescription self-ligating In-Ovation C ceramic brackets (GAC International, Bohemia, NY). The archwires were identical in the 2 groups during the 10-week experimental period: a 0.014-in M5 Heaters thermal nickel-titanium wire (G&H Wire, Franklin, Ind).
December 2016 Vol 150 Issue 6
Outcomes (primary and secondary) and any changes after trial commencement
The main outcome of the study was the change in mandibular anterior arch perimeter over the 10 weeks of the trial. The secondary outcomes were the change in the mandibular arch irregularity index over the 10 weeks and the amounts of discomfort and analgesic use during the first week of the trial. The arch perimeter was measured from the distal contact of the mandibular canines and then to the labiolingual centers of each tooth (canine to canine) according to the unpublished study from the University of Texas Health Science Center at San Antonio.16 Little's irregularity index17 was measured using a digital caliper between each contact from mandibular canine to canine (5 contacts) and summed to give the score for the arch. Patients assigned to the appliance group were asked to bring their AcceleDent Aura appliance for staff to record their daily usage, which the appliance recorded over the 10-week study interval. Since compliance with the appliance can vary and could potentially affect its efficacy, a subset of “good compliers” was assessed separately. The patients who used the appliance 75% of the time or more were considered to comply well with the appliance. A discomfort score chart was used to evaluate the pain levels experienced by each patient. The patient was instructed to record the level of discomfort at 5 time points (T0, baseline; T1, 6-8 hours later; T2, at 24 hours; T3, at 3 days; and T4, at 7 days) by placing a mark on a 100-mm visual analog scale with the left side (0) being “totally pain free,” and the extreme right (100 mm) being “worst pain ever.”18 Patients were also asked to avoid analgesics containing ibuprofen because it can slow the rate of tooth movement; if pain medications were required, they could use those containing acetaminophen.19 The same person (E.F.) blinded to the patient group measured the visual analog scale data using a digital caliper (150 mm, 500-171-20 Absolute Digimatic; Mitutoyo, Kawasaki, Japan) to the nearest 0.1 mm (caliper error, 60.02 mm). The caliper tips were closed, and the instrument rezeroed for each measurement. There were no changes to the outcome measures after trial commencement.
American Journal of Orthodontics and Dentofacial Orthopedics
Miles and Fisher
931
Patients asked to participate (N = 45)
Declined to participate (N = 5)
Assessed for eligibility
Enrolment (N = 40)
Subject assignment
Experimental group randomized (N = 20)
Control group - randomized (N = 20)
Analyzed (N = 20)
Analyzed (N = 20)
Fig. CONSORT diagram showing the flow of subjects in the study. Parents of 5 subjects declined to allow their children to participate because the parents believed the children would not comply if assigned the appliance or would not have time to comply. All subjects, once assigned, completed the trial with no lost data. Interim analyses and stopping guidelines
Not applicable. Statistical analysis (primary and secondary outcomes, subgroup analyses)
The arch perimeter, irregularity index, and visual analog scale data were assessed using median regression, and the use of analgesics was compared using a chi-square test. To assess the reliability of measuring these data, 10 randomly selected baseline models of subjects were measured again after a 2-week interval. There were mean differences between measurements of 0.07 mm in arch perimeter, 0.10 mm for the irregularity
index, and 0.05 mm for the visual analog scale. The intraclass correlation coefficients were 0.98, 1.00, and 1.00, respectively, indicating excellent measurement agreement. All analyses were conducted using Stata software (versions 12.1 and 14; StataCorp, College Station, Tex).
RESULTS Participant flow (include flow diagram, early stopping, and time periods)
A CONSORT diagram is shown in the Figure, demonstrating that all 40 patients completed this part of the
American Journal of Orthodontics and Dentofacial Orthopedics
December 2016 Vol 150 Issue 6
Miles and Fisher
932
Table I. Baseline characteristics of patients in each
group Characteristic Age (y), mean (SD) Sex Female Male
Total (n 5 40) 12.8 (1.3)
AcceleDent (n 5 20) 12.7 (1.2)
No appliance (n 5 20) 13.0 (1.5)
26 14
14 6
12 8
P 5 0.96; T2: P 5 0.75; T3: P 5 0.98; T4: P 5 0.57) or for the good compliers (T0: P 5 0.65; T1: P 5 0.89; T2: P 5 0.55; T3: P 5 0.96; T4: P 5 0.67). Analgesic use is reported in Table VIII and demonstrates no difference except at 24 hours when there was significantly less use of painkillers in the AcceleDent Aura group (T0: P 5 1.00; T1: P 5 0.72: T2: P 5 \0.01; T3: P 5 0.43; T4: P 5 0.15). Similarly, Table IX shows no significant difference with the good compliers except at 24 hours (T0: P 5 0.64; T1: P 5 0.45; T2: P 5 0.02; T3: P 5 0.45; T4: P 5 0.22).
study. They were recruited between May 2014 and June 2015, with the final set of impressions taken in September 2015.
Harms
Baseline data (include baseline table)
No negative outcomes were reported by any subject during the trial.
Information regarding age and sex are reported in Table I. The total sample had an age range of 10.5 to 15.6 years. Numbers analyzed for each outcome, estimation and precision, subgroup analyses
No impressions were missing for any time point, all 40 visual analog scale discomfort charts were returned, and data for measuring compliance were recorded from all appliances, so no data were missing. The median arch perimeter measurements and the 95% CI of the differences between the medians for all time points are shown in Table II, and those for the irregularity index are shown in Table III. The median arch perimeter data are shown in Table II, and there was no difference between the groups at any time point (Baseline: P 5 0.85; 5 weeks: P 5 0.84; 8 weeks: P 5 0.56; 10 weeks, P 5 0.67). Similarly, the median irregularity index for all time points is shown in Table III, and no significant difference between the 2 groups was noted at any time point (baseline: P 5 0.46; 5 weeks: P 5 0.80; 8 weeks: P 5 0.70; 10 weeks: P 5 0.65). The compliance data indicated a median usage of 79%, ranging from 27% to 100% (mean, 73.8%; SD, 21.7). The data for the good compliers ($75% usage; 14 subjects, or 70% of the AcceleDent Aura group) for arch perimeter are shown in Table IV, and those for the irregularity index are in Table V. The statistical analysis again indicated no significant difference at any time point for arch perimeter (Baseline: P 5 0.81; 5 weeks: P 5 0.97; 8 weeks: P 5 0.71; 10 weeks: P 5 0.89) or for the irregularity index (Baseline: P 5 0.21; 5 weeks: P 5 0.96; 8 weeks: P 5 0.92; 10 weeks: P 5 0.83) in the good compliers. Table VI shows the discomfort data for all subjects, and Table VII shows the data for the good compliers. For all time points, no difference was recorded for discomfort between the groups (T0: P 5 0.84; T1:
December 2016 Vol 150 Issue 6
DISCUSSION Main findings in the context of the evidence, interpretation
Claims of faster treatment have been made in the past by manufacturers of various self-ligating brackets, with early retrospective evidence supporting these claims.20,21 However, the ensuing prospective trials, later systematic reviews, and meta-analyses found no differences compared with conventional brackets and modes of ligation.1,22-26 Despite this evidence, some claims of shorter treatments persist, and it has been stated that this can potentially place orthodontists at risk of liability for breach of contract.27 Bracket designs and archwires only have an effect on the mechanical application of force to the dentition and not a direct effect on a patient's biology. Other techniques that target a patient's biology are available. These include more invasive techniques such as periodontally accelerated osteogenic orthodontics and corticision.28,29 Although patients may be willing to pay up to 20% more for faster treatment, they are also less willing (only 11%-34%) to have these invasive procedures done.3 Alternative and lessinvasive options have also been proposed, including low-level laser therapy,30 low-level light therapy (OrthoPulse LED; Biolux Research, Vancouver, British Columbia, Canada),31 and microvibration such as AcceleDent.12 These less-invasive options are more appealing, with 50% to 61% of patients willing to pay for and undergo treatment with a vibrating appliance.3 However, this was based on the premise that the appliance delivers what it claims. This prospective randomized clinical trial was designed to be similar to a previous trial involving the Tooth Masseuse appliance to evaluate the amount of alignment that had taken place during the first 10 weeks of the initial alignment stage of treatment in nonextraction subjects.
American Journal of Orthodontics and Dentofacial Orthopedics
Miles and Fisher
933
Table II. Anterior arch perimeter: medians and 95% confidence intervals of the differences between the appliance and
control group medians for all subjects Time point Baseline 5 weeks 8 weeks 10 weeks
AcceleDent 37.1 mm 37.1 mm 37.6 mm 37.7 mm
P value 0.85 0.84 0.56 0.67
No appliance 36.5 mm 37.3 mm 37.9 mm 37.8 mm
Difference of medians (95% CI) 0.6 mm ( 1.6, 11.8 mm) 0.2 mm ( 1.6, 11.2 mm) 0.3 mm ( 1.6, 10.7 mm) 0.1 mm ( 1.5, 11.1 mm)
Table III. Little's irregularity index: medians and 95% confidence intervals of the differences between the appliance
and control group medians for all subjects Time point Baseline 5 weeks 8 weeks 10 weeks
AcceleDent 3.9 mm 2.0 mm 1.8 mm 1.7 mm
P value 0.46 0.80 0.70 0.65
No appliance 4.4 mm 2.0 mm 1.7 mm 1.5 mm
Difference of medians (95% CI) 0.5 mm ( 2.2, 12.8 mm) 0.0 mm ( 1.0, 11.1 mm) 0.1 mm ( 0.7, 10.8 mm) 0.2 mm ( 0.6, 10.6 mm)
Table IV. Anterior arch perimeter: medians and 95% confidence intervals of the differences between the appliance
and control group medians for good compliers Time point Baseline 5 weeks 8 weeks 10 weeks
AcceleDent 37.6 mm 37.2 mm 37.7 mm 37.9 mm
P value 0.81 0.97 0.71 0.89
No appliance 36.5 mm 37.3 mm 37.9 mm 37.8 mm
Difference of medians (95% CI) 1.1 mm ( 0.7, 12.7 mm) 0.1 mm ( 1.6, 11.4 mm) 0.2 mm ( 1.6, 11.3 mm) 0.1 mm ( 1.5, 11.7 mm)
Table V. Little's irregularity index: medians and 95% confidence intervals of the differences between the appliance
and control group medians for good compliers Time point Baseline 5 weeks 8 weeks 10 weeks
AcceleDent 3.0 mm 2.0 mm 1.7 mm 1.5 mm
P value 0.21 0.96 0.92 0.83
No appliance 4.4 mm 2.0 mm 1.7 mm 1.5 mm
In our trial, we found no statistical or clinical difference between the controls and the AcceleDent Aura users in the mandibular arch; this agrees with the Tooth Masseuse trial. It also agrees with an RCT evaluating the mandibular arch's initial and final alignments in extraction patients.15 This is at odds with the initial case report with headgear.7 However, the headgear study used different force levels applied at different time points. The graph shown in that study indicated an accelerated rate of movement with the pulsed force line becoming steeper and deviating away from the control line. However, when the control side had a higher force applied later, the slope of the control line then became parallel to the experimental side, suggesting that the change was more related to the
Difference of medians (95% CI) 1.4 mm ( 3.6, 11.2 mm) 0.0 mm ( 1.1, 11.2 mm) 0.0 mm ( 0.7, 10.8 mm) 0.0 mm ( 0.6, 10.6 mm)
timing of the higher force application rather than to the use of a pulsed force. Later studies in humans were retrospective trials with their inherent limitations, including lack of blinding and potentially greater risk of bias.12,13 One of these studies lacked a control group for comparison and concluded that the rates of tooth movement were accelerated with use of the device.12 However, movement was measured as a change in the irregularity index, and the time frame of this change was not stipulated. The authors stated that a 3-mm-per-month movement was achieved in the maxillary arch, but a 3.8-mm-per-month rate of change in irregularity has been reported by others using conventional brackets without vibration.14 The
American Journal of Orthodontics and Dentofacial Orthopedics
December 2016 Vol 150 Issue 6
Miles and Fisher
934
Table VI. Discomfort visual analog scale: medians and 95% confidence intervals of the differences between the appli-
ance and control group medians for all subjects Time point Baseline 6 hours 24 hours 3 days 7 days
AcceleDent 8.0 mm 46.3 mm 50.5 mm 21.5 mm 2.6 mm
No appliance 9.5 mm 46.0 mm 54.0 mm 22.1 mm 2.1 mm
P value 0.84 0.96 0.75 0.98 0.57
Difference of medians (95% CI) 1.5 mm ( 15.9, 19.8 mm) 0.3 mm ( 23.5, 121.8 mm) 3.5 mm ( 27.1, 126.9 mm) 0.6 mm ( 20.6, 120.0 mm) 0.5 mm ( 5.0, 15.3 mm)
Table VII. Discomfort visual analog scale: medians and 95% confidence intervals of the differences between the
appliance and control group medians for good compliers Time point Baseline 6 hours 24 hours 3 days 7 days
AcceleDent 11.5 mm 46.3 mm 43.6 mm 24.5 mm 2.3 mm
No appliance 9.5 mm 46.0 mm 54.0 mm 22.1 mm 2.1 mm
Table VIII. Users of analgesics for all subjects Time point Baseline 6 hours 24 hours 3 days 7 days
AcceleDent (%) 7 (35) 14 (70) 12 (60) 3 (15) 0 (0)
No appliance (%) 7 (35) 15 (75) 19 (95) 4 (20) 1 (5)
Chi-square P 5 1.00 P 5 0.72 P \0.01* P 5 0.68 P 5 0.31
*P \0.05
Table IX. Users of analgesics for the good compliers Time point Baseline 6 hours 24 hours 3 days 7 days
AcceleDent (%) 6 (43) 12 (86) 9 (64) 2 (14) 0 (0)
No appliance (%) 7 (35) 15 (75) 19 (95) 4 (20) 1 (5)
Chi-square P 5 0.64 P 5 0.45 P 5 0.02* P 5 0.67 P 5 0.40
*P \0.05
unpublished AcceleDent trial reported a 106% improvement in the rate of change in arch perimeter per week,16 whereas we found no difference in the arch perimeter. However, the AcceleDent trial started with a sample of 45 subjects and only reported data for 14 subjects, of whom only 5 used the appliance, so the rationale for this apparent selection bias is unknown. For these reasons, the results of that unreported study should be viewed with caution.
December 2016 Vol 150 Issue 6
P value 0.65 0.89 0.55 0.96 0.67
Difference of medians (95% CI) 2.0 mm ( 15.0, 120.1 mm) 0.3 mm ( 25.2, 123.6 mm) 10.4 mm ( 32.2, 132.1 mm) 2.4 mm ( 19.2, 130.3 mm) 0.2 mm ( 5.2, 15.4 mm)
For the appliance to have any potential effect, it needs to be used as directed or at least mostly so. The AcceleDent appliance records the daily usage data by the patient. This is extremely useful for giving feedback to patients to encourage use of the appliance and also for measuring the usage and any effect of compliance on the rate of movement. In a previous RCT, the timers in the appliances were found to be unreliable, resulting in incomplete sets of data, and so the data were not used.15 However, those authors used an older model of the appliance that may have been a factor as well as a longer period (approximately 33 weeks) than our trial in which no data were lost during the 10-week period. A previous study over 6 months found that patients subjectively reported 80% usage, but the appliance recorded only a 67% compliance rate.12 In our study, the median compliance rate measured by the appliance was 79% over 10 weeks; this compares favorably. This assumes that the patients did in fact wear the appliance rather than just turning it on without placing it in their mouths.15 However, this can occur in any setting and is part of a real-world trial. When we evaluated the good compliers using the appliance 75% of the time or more, there was still no difference detected, so the poorer users did not affect the overall finding of no difference between the groups. Vibration has also been suggested to reduce the discomfort during the initial alignment stage of orthodontic treatment.32 The authors of that study found a significant difference between Tooth Masseuse users and nonusers at various time points from 2 hours to
American Journal of Orthodontics and Dentofacial Orthopedics
Miles and Fisher
935
3 days after bracket placement. However, there was no baseline measure to rule out any difference in baseline discomfort ratings, so there is the chance that those using the appliance exhibited a placebo effect. In contrast, another previous study of the Tooth Masseuse found no significant difference in discomfort levels at any time point during the first week of treatment.14 We found no difference in discomfort at any time point, but there was significantly less use of analgesics in the appliance group at day 1 but at no other time point. A recent RCT of the AcceleDent Aura appliance concluded that the appliance lowered the scores for overall pain and biting pain during the 4-month study period.33 That study had a larger sample that could account for the more significant results compared with our trial. However, like the current trial, it lacked a sham appliance, and the sole purpose of that trial was to evaluate pain, so a placebo effect could have been involved.
were, and the results reflect real-world use of the appliance with compliance similar to another report.12 It would therefore be expected to have generalizability to other adolescent subjects with fixed appliances for a Class II malocclusion involving 2 maxillary premolar extractions.
Limitations
4.
The sample size for this study was calculated to require 17 subjects per group, and 20 were enrolled. Since only 14 of the 20 subjects were considered to be good compliers ($75% usage), then the study could have been underpowered because of poor compliance. Future trials should consider this. In this trial, the greatest differences between the median irregularity index were only 0.5 and 0.6 mm in arch perimeter at T0 in the 2 groups, so a larger sample would not have changed the clinical significance of this finding. Our subjects were not blinded to use of the appliance. This would not be expected to have any significant effect on the amount of change in arch perimeter or the irregularity index but could possibly influence the reporting of discomfort or analgesic use because of the potential placebo effect. This was not the primary outcome of this trial, but ideally future trials evaluating discomfort and analgesic use would use a sham appliance group. Generalizability
Because the patients were indirectly bonded, the maxillary premolar extractions were done after bracket placement during the 10 weeks of this trial. The extractions were performed in the maxillary arch, and the measurements were of the mandibular arch, so there was no risk of a regional acceleratory phenomenon. However, there was a potential for a systemic acceleratory phenomenon that could influence the amount of movement during the study period. Since this protocol occurred in both groups, it would not have influenced any difference between the groups. Although the subjects were not blinded, the clinician (P.M.) and the assessor (E.F.)
CONCLUSIONS
1.
2.
3.
The AcceleDent Aura appliance had no effect on the rate of change in the anterior arch perimeter during initial alignment in the mandibular arch of adolescent subjects. The appliance had no significant effect on the rate of change in irregularity in the mandibular arch of adolescent subjects. The level of discomfort was not affected by use of the AcceleDent Aura appliance in adolescent subjects. Significantly fewer subjects in the AcceleDent Aura group used analgesics at day 1 (P \0.01).
SUPPLEMENTARY DATA
Supplementary data related to this article can be found online at http://dx.doi.org/10.1016/j.ajodo. 2016.07.016. REFERENCES 1. Songra G, Clover M, Atack NE, Ewings P, Sherriff M, Sandy JR, et al. Comparative assessment of alignment efficiency and space closure of active and passive self-ligating vs conventional appliances in adolescents: a single-center randomized controlled trial. Am J Orthod Dentofacial Orthop 2014;145:569-78. 2. Fink DF, Smith RJ. The duration of orthodontic treatment. Am J Orthod Dentofacial Orthop 1992;102:45-51. 3. Uribe F, Padala S, Allareddy V, Nanda R. Patients', parents', and orthodontists' perceptions of the need for and costs of additional procedures to reduce treatment time. Am J Orthod Dentofacial Orthop 2014;145(Suppl):S65-73. 4. Krishnan V, Davidovitch Z. Cellular, molecular, and tissue-level reactions to orthodontic force. Am J Orthod Dentofacial Orthop 2006;129:469.e1-32. 5. Proffit WR. Contemporary orthodontics. 4th ed. St Louis: Mosby; 2007. p. 331-8. 6. Grimm FM. Bone bending, a feature of orthodontic tooth movement. Am J Orthod 1972;62:384-93. 7. Shapiro E, Roeber FW, Klempner LS. Orthodontic movement using pulsating force-induced piezoelectricity. Am J Orthod 1979;76: 59-66. 8. Darendeliler MA, Zea A, Shen G, Zoellner H. Effects of pulsed electromagnetic field vibration on tooth movement induced by magnetic and mechanical forces: a preliminary study. Aust Dent J 2007;52:282-7. 9. Nishimura M, Chiba M, Ohashi T, Sato M, Shimizu Y, Igarashi K, et al. Periodontal tissue activation by vibration: intermittent stimulation by resonance vibration accelerates experimental tooth
American Journal of Orthodontics and Dentofacial Orthopedics
December 2016 Vol 150 Issue 6
Miles and Fisher
936
10.
11. 12.
13. 14.
15.
16.
17. 18.
19.
20. 21.
movement in rats. Am J Orthod Dentofacial Orthop 2008;133: 572-83. Shimizu Y. Movement of the lateral incisors of the Macaca fuscata as loaded by a vibrating force. Nihon Kyosei Shika Gakkai Zasshi 1986;45:56-72. Kau CH. A novel device in orthodontics. Aesthetic Dent Today 2009;3:42-3. Kau CH, Nguyen JT, English JD. The clinical evaluation of a novel cyclical force generating device in orthodontics. Orthod Pract 2010;1:1-4. Bowman SJ. The effect of vibration on the rate of leveling and alignment. J Clin Orthod 2014;48:678-88. Miles P, Smith H, Weyant R, Rinchuse DJ. The effects of a vibrational appliance on tooth movement and patient discomfort: a prospective randomised clinical trial. Aust Orthod J 2012;28: 213-8. Woodhouse NR, DiBiase AT, Johnson N, Slipper C, Grant J, Alsaleh M, et al. Supplemental vibrational force during orthodontic alignment: a randomized trial. J Dent Res 2015;94: 682-9. AcceleDent increases the rate of orthodontic tooth movement: results of a randomized controlled clinical trial. Available at: http:// AcceleDent.com/wp-content/uploads/2013/04/RCT.pdf. Accessed June 15, 2015. Little R. The irregularity index: a quantitative score of mandibular anterior alignment. Am J Orthod 1975;68:554-63. Duncan GH, Bushnell MC, Lavigne GJ. Comparison of verbal and visual analogue scales for measuring the intensity and unpleasantness of experimental pain. Pain 1989;37:295-303. Kehoe MJ, Cohen SM, Zarrinnia K, Cowan A. The effect of acetaminophen, ibuprofen, and misoprostol on prostaglandin E2 synthesis and the degree and rate of orthodontic tooth movement. Angle Orthod 1996;66:339-49. Harradine NW. Self-ligating brackets and treatment efficiency. Clin Orthod Res 2001;4:220-7. Eberting JJ, Straja SR, Tuncay OC. Treatment time, outcome, and patient satisfaction comparisons of Damon and conventional brackets. Clin Orthod Res 2001;4:228-34.
December 2016 Vol 150 Issue 6
22. Miles PG, Weyant RJ, Rustveld L. A clinical trial of Damon 2 vs conventional twin brackets during initial alignment. Angle Orthod 2006;76:480-5. 23. Scott P, DiBiase AT, Sherriff M, Cobourne MT. Alignment efficiency of Damon3 self-ligating and conventional orthodontic bracket systems: a randomized clinical trial. Am J Orthod Dentofacial Orthop 2008;134:470.e1-8. 24. Fleming PS, Johal A. Self-ligating brackets in orthodontics. A systematic review. Angle Orthod 2010;80:575-84. 25. Chen SS, Greenlee GM, Kim JE, Smith CL, Huang GJ. Systematic review of self-ligating brackets. Am J Orthod Dentofacial Orthop 2010;137:726.e1-18. 26. Papageorgiou SN, Konstantinides I, Papadopoulou K, Jager A, Bourauel C. Clinical effects of pre-adjusted orthodontic brackets: a systematic review and meta-analysis. Eur J Orthod 2014;36: 350-63. 27. Jerrold L. Accelerated orthodontics or accelerated liability? Am J Orthod Dentofacial Orthop 2014;145(Suppl 4):S148-51. 28. Wilcko MT, Wilcko WM, Bissada NF. An evidence-based analysis of periodontally accelerated orthodontic and osteogenic techniques: a synthesis of scientific perspectives. Semin Orthod 2008;14: 305-16. 29. Kim SJ, Park YG, Kang SG. Effects of corticision on paradental remodeling in orthodontic tooth movement. Angle Orthod 2009;79: 284-91. 30. Youssef M, Ashkar S, Hamade E, Gutknecht N, Lampert F, Mir M. The effect of low-level laser therapy during orthodontic movement: a preliminary study. Lasers Med Sci 2008;23:27-33. 31. Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, et al. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod 2013;14:30. 32. Marie SS, Powers M, Sheridan JJ. Vibratory stimulation as a method of reducing pain after orthodontic appliance adjustment. J Clin Orthod 2003;37:205-8. 33. Lobre WD, Callegari BJ, Gardner G, Marsh CM, Bush AC, Dunn WJ. Pain control in orthodontics using a micropulse vibration device: a randomized clinical trial. Angle Orthod 2016;86: 625-30.
American Journal of Orthodontics and Dentofacial Orthopedics
