The effect of supplemental vibration on orthodontic treatment with aligners - A Randomized Clinical Trial
MetadataShow full item record
Background: Supplemental vibration has been introduced to orthodontics to accelerate the rate of tooth movement and to reduce patient discomfort. Purpose: This study investigated the impact of the AcceleDent® device on Invisalign® treatment. Specifically, we wished to determine if using the AcceleDent® device allowed aligners to be changed with a one-week, rather than the usual two-week, regimen. Design: This 2-armed, randomized, triple-blinded, active-controlled clinical trial was carried out in 2 orthodontic practices in Seattle, WA and Vancouver, BC with a 1:1 allocation ratio. 26 adult subjects (12 male and 14 female, mean age=33) were randomly allocated to either an active or control AcceleDent® device. The control devices were exactly like the active devices, but the coupler that transmitted the force to the mouthpiece was removed. All patients were placed on a one-week regimen for changing aligners and were evaluated by their orthodontist every three weeks. If the fit was adequate, the patients would continue with treatment. If there was a lack of fit, based on pre-established guidelines, the patient would be considered a non-completer. The primary outcome compared the percentage of completers in the active and control groups. A secondary outcome measured the final incisor irregularity and the change in incisor irregularity for those who completed their regimen of aligners. Results: Fisher’s exact test showed no significant difference in completion rates between the two groups (Active = 77% completion, Control = 85% completion, p=.99). Independent-sample t-tests showed no significant difference between final incisor irregularity (p=0.75) or the change in incisor irregularity (p=0.74) between the two groups. Compliance with aligners and the AcceleDent® device were similar in both groups. Conclusions: This study found no evidence that AcceleDent® impacts the ability to complete a series of aligners with a one-week change regimen or the final alignment achieved in this adult patient. REGISTRATION: ClinicalTrials.gov Identifier: NCT02438280. This study was approved by the University of Washington Institutional Review Board (ID: 49073-D). FUNDING: This study was funded by OrthoAccel® Technologies.
- Dentistry