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NCT03794726 | NOT YET RECRUITING | Malocclusion

Comparison of Orthodontic Molar Protraction with and Without Adjunctive Surgery
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Maria L. Geisinger, DDS, MS

Brief Summary:

This study will compare orthodontic molar protraction with and without adjunctive periodontally accelerated osteogenic orthodontic (PAOO) surgery prior to orthodontic tooth movement. To the investigators' knowledge, this type of molar retraction in adult patients has not been compared with and without the adjunctive use of PAOO for differences in clinical linear tooth movement and patient centered outcomes (discomfort, change in daily activities, satisfaction with esthetic outcomes) in a controlled study.

Condition or disease

Malocclusion

Intervention/treatment

Orthodontic Molar Protraction and PAOO

Orthodontic Molar Protraction

Phase

NA

Detailed Description:

Research data and daily clinical observations reveal that molar protraction (forward movement) in adult patients may be prolonged and ideal outcomes may not be achieved with traditional orthodontic tooth movement. One method for enhancing orthodontic tooth movement is the use of surgical access of the local site to initiate a regional tissue reaction to induce trauma, which leads to a limited inflammatory healing process. This process is also known as regional acceleratory phenomenon (RAP), which allows for more rapid bone turnover and has been shown in other protocols to enhance orthodontic tooth movement. While PAOO has been shown to rapidly increase tooth movement, to our knowledge, localized use of PAOO in combination with molar protraction in adults has not been evaluated in a prospective trial for differences in clinical outcomes (tooth movement time, adverse orthodontic outcomes, periodontal and soft tissue defects) and patient-centered outcomes (pain, swelling, change in daily activities, patient assessment of surgical benefit, and patient-assessed esthetics) in a controlled study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 40 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : A Prospective, Randomized Clinical Trial to Compare Orthodontic Molar Protraction with and Without Adjunctive Periodontally Accelerated Osteogenic Orthodontic (PAOO) Surgery.
Actual Study Start Date : 2025-01
Estimated Primary Completion Date : 2026-12-30
Estimated Study Completion Date : 2027-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * English speaking
  • * At least 18 years old
  • * Must be a patient of the University of Alabama at Birmingham (UAB) Dental School
  • * Able to read and understand informed consent document
  • * One or more nonadjacent 1st or 2nd molar teeth that require protraction of ≥ 5 mm in patients undergoing orthodontic tooth movement
  • * Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or edentulous ridges on either side of the involved site(s)
  • * No anticipated need for restorative care at the teeth to be treated during the study period.
Exclusion Criteria
  • * Non-English speaking
  • * Less than 18 years old
  • * Smokers/tobacco users (\>10 cigarettes/day)
  • * Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
  • * Presence of active periodontal disease, caries, and/or periapical pathology at teeth to be moved orthodontically
  • * Previous orthodontic therapy involving molar protraction of teeth to be treated
  • * Previous periodontal surgery at site(s) to be treated
Comparison of Orthodontic Molar Protraction with and Without Adjunctive Surgery

Location Details

NCT03794726

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