Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

Completed · Phase 4 · Has a placebo group

Conditions studied: Malocclusion

In brief

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.

Key facts

Study ID

NCT01962012

Run by

OrthoAccel Technologies Inc.

People needed

46

Starts

2013-10-01

Expected to finish

2016-05-01

Last updated by the study team

2016-09-28

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• University of Florida, Department of Orthodontics — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

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