Back to resultsEffect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
Primary Purpose
Malocclusion
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
AcceleDent Aura
Sham Device
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Orthodontic, Orthodontic Treatment, Accelerated Tooth Movement, Malocclusion, Device, AcceleDent Aura, Clear Aligners
Eligibility Criteria
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.
Sites / Locations
- University of Florida, Department of Orthodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
AcceleDent Aura
Sham Device
Arm Description
AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Sham devices will look identical to active devices but will not deliver vibration to the patient.
Outcomes
Primary Outcome Measures
Rate of Orthodontic Tooth Movement (mm/week)
Secondary Outcome Measures
Pain (Visual Analog Scale)
Full Information
NCT ID
NCT01962012
First Posted
October 8, 2013
Last Updated
September 27, 2016
Sponsor
OrthoAccel Technologies Inc.
Collaborators
University of Florida
1. Study Identification
Unique Protocol Identification Number
NCT01962012
Brief Title
Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
Official Title
Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
OrthoAccel Technologies Inc.
Collaborators
University of Florida
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion
Keywords
Orthodontic, Orthodontic Treatment, Accelerated Tooth Movement, Malocclusion, Device, AcceleDent Aura, Clear Aligners
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AcceleDent Aura
Arm Type
Experimental
Arm Description
AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Arm Title
Sham Device
Arm Type
Sham Comparator
Arm Description
Sham devices will look identical to active devices but will not deliver vibration to the patient.
Intervention Type
Device
Intervention Name(s)
AcceleDent Aura
Intervention Type
Device
Intervention Name(s)
Sham Device
Primary Outcome Measure Information:
Title
Rate of Orthodontic Tooth Movement (mm/week)
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
Pain (Visual Analog Scale)
Time Frame
3 Days After Receiving New Aligner
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy T Wheeler, DMD, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida, Department of Orthodontics
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners
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