Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery

NCT03794726 | Not Yet Recruiting

• 2 other identifiers: IRB-300002013UAB-Perio
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Malocclusion

Keywords

Orthodontic tooth movement; Molar protraction; Periodontally accelerated osteogenic orthodontics; Patient-centered outcomes

Outcome Measures

Primary Outcomes (2)

• Linear millimeters of molar tooth movement

  Compare the clinical linear molar tooth movement over a 3 month time frame (Baseline to 3 months) between two groups receiving orthodontic therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO).

  From baseline to 3months

• Tooth angulation as measured radiographically

  Compare the radiographic mesial inclination of the molar to be protracted over a 3-month time frame (Baseline to 3 months) between two groups receiving orthodontics therapy alone or in combination with periodontally accelerated osteogenic orthodontics (PAOO).

  From baseline to 3months

Secondary Outcomes (9)

• Periodontal probing depth

  From baseline to 3months

• Periodontal clinical attachment level

  From baseline to 3months

• Periodontal width of keratinized tissue

  From baseline to 3months

• Periodontal width of attached tissue

  From baseline to 3months

• Practitioner-assessed treatment outcomes

  From baseline to 3months

Study Arms (2)

Orthodontic Molar Protraction

ACTIVE COMPARATOR

Molar protraction using orthodontic tooth movement alone

Procedure: Orthodontic Molar Protraction

Orthodontic Molar Protraction and PAOO

EXPERIMENTAL

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

Procedure: Orthodontic Molar Protraction and PAOO

Interventions

Orthodontic Molar Protraction and PAOO PROCEDURE

Molar Protraction with Orthodontic Tooth Movement and Adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO) Surgery was performed on all study sites in this arm in coordination with standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.

Orthodontic Molar Protraction and PAOO

Orthodontic Molar Protraction PROCEDURE

Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.

Orthodontic Molar Protraction

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Maria L Geisinger, DDS,MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria L. Geisinger, DDS,MS

CONTACT

996-7011; mlgdds@uab.edu

Sarah Startley

CONTACT

205-975-8711

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: January 7, 2019
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 20, 2026

Record last verified: 2026-03