A Phase 4 interventional study of AcceleDent Aura and Sham Device in Malocclusion, sponsored by OrthoAccel Technologies Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-28.
Sponsored by OrthoAccel Technologies Inc. · Phase 4, Interventional, and Treatment
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.
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.
457 studies on the registry are indexed under Malocclusion; 89 are open to participants now.
This study's enrollment of 46 is above the median of 36 across 372 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →OrthoAccel Technologies Inc. is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Device: AcceleDent Aura
Sham devices will look identical to active devices but will not deliver vibration to the patient.
Device: Sham Device
Rate of Orthodontic Tooth Movement (mm/week)
Time frame: 12 Weeks
Pain (Visual Analog Scale)
Time frame: 3 Days After Receiving New Aligner
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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OrthoAccel Technologies Inc.