Clinical trial NCT03794726: Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery
Official title: A Prospective, Randomized Clinical Trial to Compare Orthodontic Molar Protraction With and Without Adjunctive Periodontally Accelerated Osteogenic Orthodontic (PAOO) Surgery.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Malocclusion
Keywords: Orthodontic tooth movement
Molar protraction
Periodontally accelerated osteogenic orthodontics
Patient-centered outcomes
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Linear millimeters of molar tooth movement
timeFrame: From baseline to 3months
measure: Tooth angulation as measured radiographically
timeFrame: From baseline to 3months
Secondary outcomes:
measure: Periodontal probing depth
timeFrame: From baseline to 3months
measure: Periodontal clinical attachment level
timeFrame: From baseline to 3months
measure: Periodontal width of keratinized tissue
timeFrame: From baseline to 3months
measure: Periodontal width of attached tissue
timeFrame: From baseline to 3months
measure: Practitioner-assessed treatment outcomes
timeFrame: From baseline to 3months
measure: Patient-assessed esthetic outcomes
timeFrame: From baseline to 3months
measure: Patient centered post-operative discomfort assessment
timeFrame: From baseline to 3months
measure: Patient centered global treatment satisfaction
timeFrame: From baseline to 3months
measure: Patient centered alteration of daily activities assessment
timeFrame: From baseline to 3months
Other outcomes:
Locations:
Study officials:
affiliation: University of Alabama at Birmingham
name: Maria L Geisinger, DDS,MS
role: PRINCIPAL_INVESTIGATOR
References: