- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01962012
Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida, Department of Orthodontics
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females between and including the ages of 18 and 40 yo desiring orthodontic treatment that could be completed within two years of treatment with either fixed appliances or aligner treatment. Subjects may have had previous orthodontic procedures.
- Adult dentition with all upper front teeth present and any premolar and molar combination in the upper posterior of two teeth on each side.
- At least one upper maxillary central incisor that is positioned to allow anterio-posterior (AP) movement (crown tipping only) of 1.98 mm.
- Normal pulp vitality and healthy periodontal tissues as determined by intraoral exam.
- Good health as determined by medical history.
- Willingness and ability to comply with study procedures, attend study visits, and complete the study.
- The ability to understand and sign a written informed consent form, which must be signed prior to initiation of study procedures.
Exclusion Criteria:
- Severe malocclusions that would take longer than 2 years of treatment or require surgical intervention.
- Significant periodontal disease (> 3mm pocket depth or >1 mm of recession on upper anterior teeth).
- Active caries not under care of either a dentist or periodontist.
- Chronic daily use of any non-steroidal anti-inflammatory medication, estrogen, calcitonin, or corticosteroids.
- History of use or current use of any bisphosphonate medication or other medication for treatment of osteoporosis.
- Current smoker (must not have smoked in the last 6 months).
- Women may not be pregnant. Negative urine pregnancy tests prior to exposure to cone beam imaging is required to verify pregnancy status.
- Any condition or use of medication which in the opinion of the investigator interferes with the biology of tooth movement.
- Any condition which in the opinion of the investigator results in increased risk to the subject.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: AcceleDent Aura
AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
|
|
SHAM_COMPARATOR: Sham Device
Sham devices will look identical to active devices but will not deliver vibration to the patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Rate of Orthodontic Tooth Movement (mm/week)
Time Frame: 12 Weeks
|
12 Weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain (Visual Analog Scale)
Time Frame: 3 Days After Receiving New Aligner
|
3 Days After Receiving New Aligner
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Timothy T Wheeler, DMD, PhD, University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OA-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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