Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

NCT01962012 | Completed Phase 4

• 1 other identifier: OA-03
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion

Keywords

Orthodontic; Orthodontic Treatment; Accelerated Tooth Movement; Malocclusion; Device; AcceleDent Aura; Clear Aligners

Outcome Measures

Primary Outcomes (1)

• Rate of Orthodontic Tooth Movement (mm/week)

  12 Weeks

Secondary Outcomes (1)

• Pain (Visual Analog Scale)

  3 Days After Receiving New Aligner

Study Arms (2)

AcceleDent Aura

EXPERIMENTAL

AcceleDent Aura device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.

Device: AcceleDent Aura

Sham Device

SHAM COMPARATOR

Sham devices will look identical to active devices but will not deliver vibration to the patient.

Device: Sham Device

Interventions

AcceleDent Aura DEVICE

AcceleDent Aura

Sham Device DEVICE

Sham Device

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OrthoAccel Technologies Inc.: lead
• University of Florida: collaborator

Study Sites (1)

University of Florida, Department of Orthodontics

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Timothy T Wheeler, DMD, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2013
• First Posted: October 14, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: May 1, 2016
• Last Updated: September 28, 2016

Record last verified: 2016-09

Locations

US (1)