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Search / Trial NCT01962012

Effect of AcceleDent® Aura on Orthodontic Tooth Movement With Aligners

Launched by ORTHOACCEL TECHNOLOGIES INC. · Oct 9, 2013

Trial Information

Current as of May 10, 2025

Completed

Keywords

Orthodontic Orthodontic Treatment Accelerated Tooth Movement Malocclusion Device Accele Dent Aura Clear Aligners

ClinConnect Summary

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 subjec...

Gender

ALL

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.

About Orthoaccel Technologies Inc.

OrthoAccel Technologies Inc. is a leading innovator in orthodontic technology, dedicated to enhancing patient care and treatment outcomes through advanced dental solutions. The company specializes in the development and commercialization of devices that accelerate orthodontic treatment, with a focus on improving efficiency and patient comfort. By leveraging cutting-edge research and engineering, OrthoAccel aims to transform the orthodontic landscape, providing practitioners with tools that streamline processes and enhance the overall patient experience. Committed to clinical excellence, the company actively engages in clinical trials to validate the efficacy and safety of its products, ensuring they meet the highest standards of dental practice.

Locations

Gainesville, Florida, United States

Patients applied

0 patients applied

Trial Officials

Timothy T Wheeler, DMD, PhD

Principal Investigator

University of Florida

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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