Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners|
- Rate of Orthodontic Tooth Movement (mm/week) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Pain (Visual Analog Scale) [ Time Frame: 3 Days After Receiving New Aligner ] [ Designated as safety issue: No ]
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Experimental: AcceleDent Aura
AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
|Device: AcceleDent Aura|
Sham Comparator: Sham Device
Sham devices will look identical to active devices but will not deliver vibration to the patient.
|Device: Sham Device|
There are many variables that can affect the rate of tooth movement. Preliminary data showed that the rate of tooth movement may be affected by variables such as age, sex, as well as alveolar bone levels, tooth root length and alveolar bone quality. The purpose of this study is to examine the amount of tooth movement achieved over time between subjects undergoing aligner treatment using a pulsation device known as AcceleDent® Aura with those not using the device.
A preliminary validation pilot study will be done to calibrate all staff on study procedures. The pilot will consist of 3 subjects using the active AcceleDent® Aura device and 3 using the sham control AcceleDent® Aura device for 4 weeks. Study staff will be calibrated for all study procedures.
The primary study will be a prospective, single-center, randomized crossover clinical trial comparing two groups of subjects with 40 participants. Subjects will be randomized to groups that will receive aligner treatment while using either an active AcceleDent® Aura device or a sham control AcceleDent® Aura device for the first 6 weeks of the study. After 6 weeks, groups will cross-over and switch devices, and tooth movement will be followed for another 6 weeks. Patients will be blinded as to which device they are using. Amount of tooth movement per week, pain perception, and change in gingival crevicular fluid biomarkers will be outcomes assessed. Device safety evaluation to be performed will include adverse events and clinical examination findings including pulp vitality testing and periodontal probe results.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01962012
|United States, Florida|
|University of Florida, Department of Orthodontics||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Vicki Mayo 352-273-5695 VMAYO@dental.ufl.edu|
|Principal Investigator: Timothy T Wheeler, DMD, PhD|
|Principal Investigator:||Timothy T Wheeler, DMD, PhD||University of Florida|