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Accelerated Invisalign Therapy in Conjunction With Acceledent Aura

NCT02868554 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-01-27

Study results available
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Summary

Purpose:

The objective of this study is to investigate the effects of accelerated Invisalign and vibration therapy on rate of orthodontic tooth movement, activation of inflammation biomarkers as well as pain levels experienced by orthodontic patients during the initial 12 weeks of alignment.

Participants:

Up to 30 orthodontic patients of the University of North Carolina Orthodontic Residency Program will be recruited for this study. Patients older than 18 years old will be otherwise healthy subjects previously diagnosed with malocclusion.

Procedures (methods):

Each patient will be randomly allocated into either a control group or one of two intervention groups. Patients within the control group will receive standard Invisalign therapy without vibration. Patients within the intervention groups will receive accelerated Invisalign therapy with or without vibration. Patients receiving vibration therapy will utilize an AcceleDent Aura device which provides a light vibration at .25 Newtons (N) and 30 Hertz (Hz) frequency for twenty minutes daily. Three dimensional images of each subject's dentition will be recorded five times at 0 days, 4 days, 2 weeks, 6 weeks, and 12 weeks progress visits.

Conditions

  • Malocclusion

Interventions

DEVICE

AcceleDent Aura

Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.

DEVICE

Accelerated Invisalign therapy

Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.

Sponsors & Collaborators

  • OrthoAccel Technologies Inc.

    collaborator INDUSTRY

  • University of North Carolina, Chapel Hill

    lead OTHER

Principal Investigators

  • Ching C Ko, DDS, PhD · UNC Department of Orthodontics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2019-04-26
Completion
2019-04-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02868554 on ClinicalTrials.gov