Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by OrthoAccel Technologies Inc.
Sponsor:
Collaborator:
University of Florida
Information provided by (Responsible Party):
OrthoAccel Technologies Inc.
ClinicalTrials.gov Identifier:
NCT01962012
First received: October 8, 2013
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Malocclusion
Device: AcceleDent Aura
Device: Sham Device
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

Further study details as provided by OrthoAccel Technologies Inc.:

Primary Outcome Measures:
  • Rate of Orthodontic Tooth Movement (mm/week) [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain (Visual Analog Scale) [ Time Frame: 3 Days After Receiving New Aligner ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: October 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AcceleDent Aura
AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.
Device: AcceleDent Aura
Sham Comparator: Sham Device
Sham devices will look identical to active devices but will not deliver vibration to the patient.
Device: Sham 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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962012

Locations
United States, Florida
University of Florida, Department of Orthodontics Recruiting
Gainesville, Florida, United States, 32610
Contact: Vicki Mayo    352-273-5695    VMAYO@dental.ufl.edu   
Principal Investigator: Timothy T Wheeler, DMD, PhD         
Sponsors and Collaborators
OrthoAccel Technologies Inc.
University of Florida
Investigators
Principal Investigator: Timothy T Wheeler, DMD, PhD University of Florida
  More Information

No publications provided

Responsible Party: OrthoAccel Technologies Inc.
ClinicalTrials.gov Identifier: NCT01962012     History of Changes
Other Study ID Numbers: OA-03
Study First Received: October 8, 2013
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by OrthoAccel Technologies Inc.:
Orthodontic
Orthodontic Treatment
Accelerated Tooth Movement
Malocclusion
Device
AcceleDent Aura
Clear Aligners

Additional relevant MeSH terms:
Malocclusion
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 18, 2014