Clinical Trial: Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

Brief Summary: 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.

Detailed Summary:

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.

Sponsor: OrthoAccel Technologies Inc.

Current Primary Outcome: Rate of Orthodontic Tooth Movement (mm/week) [ Time Frame: 12 Weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Pain (Visual Analog Scale) [ Time Frame: 3 Days After Receiving New Aligner ]

Original Secondary Outcome: Same as current

Information By: OrthoAccel Technologies Inc.

Dates:
Date Received: October 8, 2013
Date Started: October 2013
Date Completion:
Last Updated: September 27, 2016
Last Verified: September 2016