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Search / Trial NCT02868554

Accelerated Invisalign Therapy in Conjunction With Acceledent Aura

Launched by UNIVERSITY OF NORTH CAROLINA, CHAPEL HILL · Aug 14, 2016

Trial Information

Current as of May 03, 2025

Completed

Keywords

ClinConnect Summary

Align Technology©, Inc. developed Invisalign® in 1997 to meet the esthetic demands of orthodontic patients and providers. Invisalign patients receive a series of computer-assisted designed stereolithic clear retainers to incrementally resolve their malocclusion. Invisalign® and other advances in orthodontic technology such as clear aligners, ceramic brackets and lingual braces offer options to address the esthetic demands of most orthodontic patients but duration of treatment continues to be one of the most challenging aspects of practice.

In 2008, OrthoAccel Technologies©, Inc. developed ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Males or females over the age of 18 years old desiring orthodontic treatment.
  • 2. Adult dentition with all upper and lower front teeth present and any premolar and molar combination in the upper posterior of two teeth on each side.
  • 3. Normal pulp vitality and healthy periodontal tissues as determined by intraoral exam.
  • 4. Good health as determined by medical history.
  • 5. Willingness and ability to comply with study procedures, attend study visits, and complete the study.
  • 6. The ability to understand and sign a written informed consent form, which must be signed prior to initiation of study procedures.
  • Exclusion Criteria:
  • 1. Patient under the age of 18 years old
  • 2. Women may not be pregnant. Negative urine pregnancy tests prior to exposure to cone beam imaging is required to verify pregnancy status.
  • 3. Patients diagnosed with systemic diseases such as diabetes, hypertension (high blood pressure), temporomandibular disorders (jaw disorders), or craniofacial syndromes.
  • 4. Severe malocclusions that would require adjunctive procedures other than Invisalign. These include impacted teeth, closure of extractions spaces.
  • 5. Significant periodontal disease (\> 4mm pocket depth or \>2 mm of recession on upper anterior teeth).
  • 6. Active caries not under care of either a dentist or periodontist.
  • 7. Chronic daily use of any non-steroidal anti-inflammatory medication, estrogen, calcitonin, or corticosteroids.
  • 8. History of use or current use of any bisphosphonate medication or other medication for treatment of osteoporosis.
  • 9. Current smoker (must not have smoked in the last 6 months).
  • 10. Failing to comply with research protocols

About University Of North Carolina, Chapel Hill

The University of North Carolina at Chapel Hill (UNC) is a leading research institution renowned for its commitment to advancing health and science through innovative clinical trials. With a robust infrastructure that supports multidisciplinary collaboration, UNC conducts cutting-edge research across various fields, including medicine, public health, and biomedical sciences. The university is dedicated to improving patient care and health outcomes by translating its research findings into practical applications. UNC’s clinical trials are designed to evaluate new therapies, interventions, and technologies, ensuring that they meet the highest ethical and scientific standards while fostering a culture of inclusivity and community engagement.

Locations

Chapel Hill, North Carolina, United States

Patients applied

0 patients applied

Trial Officials

Ching C Ko, DDS, PhD

Principal Investigator

UNC Department of Orthodontics

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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