Mina Katchooi1, Bobby Cohanim2, Sandra Tai3, Burcu Bayirli2, Charles Spiekerman4, Greg Huang2. 1. Department of Orthodontics, University of Washington, Seattle, Wash. Electronic address: katchmi@uw.edu. 2. Department of Orthodontics, University of Washington, Seattle, Wash. 3. Department of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada. 4. Department of Biostatistics, University of Washington, Seattle, Wash.
Abstract
INTRODUCTION:Supplemental vibration has been reported to accelerate orthodontic tooth movement and reduce discomfort. Our purpose was to investigate the effects of AcceleDent on Invisalign treatment. This randomized clinical trial was carried out in 2 orthodontic private practices with a 1:1 allocation ratio. METHODS:Adult patients who were beginning their orthodontic treatment were randomly allocated to either an active (A) or a sham (B) AcceleDent Aura device (OrthoAccel Technologies, Inc. Houston, TX). All patients were placed on a 1-week aligner change regimen, and fit was evaluated every 3 weeks. The outcomes were the ability to complete the initial set of aligners and the incisor irregularity measurements for those who completed their regimen of aligners. In addition, aligner compliance, pain levels, and oral health-related quality of life data were gathered from questionnaires. The subjects, investigators, and assessors were all blinded to the treatment arms. RESULTS:Twenty-seven subjects were randomized into 2 groups (A and B), 1 subject discontinued treatment, and 13 subjects were analyzed in each group. The Fisher exact test showed no significant difference in completion rates between the 2 groups (group A, 77%; group B, 85%; P = 1). Independent-sample t tests showed no significant difference between the final irregularity index or change in irregularity index between the 2 groups. Compliance was similar in both groups. The Wilcoxon rank sum test showed minimal differences in pain levels. Quality of life responses were similar in both groups. No serious harm was observed. CONCLUSIONS: We found no evidence that the AcceleDent Aura device impacts the ability to complete a series of aligners with a 1-week change regimen or the final alignment achieved in adult patients. It also had no significant effect on the reduction of orthodontic pain or oral health-related quality of life parameters when used with Invisalign.
RCT Entities:
INTRODUCTION: Supplemental vibration has been reported to accelerate orthodontic tooth movement and reduce discomfort. Our purpose was to investigate the effects of AcceleDent on Invisalign treatment. This randomized clinical trial was carried out in 2 orthodontic private practices with a 1:1 allocation ratio. METHODS: Adult patients who were beginning their orthodontic treatment were randomly allocated to either an active (A) or a sham (B) AcceleDent Aura device (OrthoAccel Technologies, Inc. Houston, TX). All patients were placed on a 1-week aligner change regimen, and fit was evaluated every 3 weeks. The outcomes were the ability to complete the initial set of aligners and the incisor irregularity measurements for those who completed their regimen of aligners. In addition, aligner compliance, pain levels, and oral health-related quality of life data were gathered from questionnaires. The subjects, investigators, and assessors were all blinded to the treatment arms. RESULTS: Twenty-seven subjects were randomized into 2 groups (A and B), 1 subject discontinued treatment, and 13 subjects were analyzed in each group. The Fisher exact test showed no significant difference in completion rates between the 2 groups (group A, 77%; group B, 85%; P = 1). Independent-sample t tests showed no significant difference between the final irregularity index or change in irregularity index between the 2 groups. Compliance was similar in both groups. The Wilcoxon rank sum test showed minimal differences in pain levels. Quality of life responses were similar in both groups. No serious harm was observed. CONCLUSIONS: We found no evidence that the AcceleDent Aura device impacts the ability to complete a series of aligners with a 1-week change regimen or the final alignment achieved in adult patients. It also had no significant effect on the reduction of orthodontic pain or oral health-related quality of life parameters when used with Invisalign.
Authors: Giovanna Perrotti; Alessandro Carrafiello; Ornella Rossi; Lorena Karanxha; Giulia Baccaglione; Massimo Del Fabbro Journal: Int J Environ Res Public Health Date: 2022-05-09 Impact factor: 4.614