Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery (PAOO)

The University of Alabama at Birmingham

Status: Begins enrollment this month

Conditions: Malocclusion

Treatments: Procedure: Orthodontic Molar Protraction and PAOO; Procedure: Orthodontic Molar Protraction

Study type: Interventional

Funder types: Other

Identifiers

NCT03794726

UAB-Perio (Other Identifier)

IRB-300002013

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Orthodontic Molar Protraction

Active Comparator group

Description:

Molar protraction using orthodontic tooth movement alone

Treatment:

Procedure: Orthodontic Molar Protraction

Orthodontic Molar Protraction and PAOO

Experimental group

Description:

Molar protraction using orthodontic tooth movement and adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO)

Treatment:

Procedure: Orthodontic Molar Protraction and PAOO