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

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ClinicalTrials.gov Identifier: NCT03794726
Recruitment Status : Not yet recruiting
First Posted : January 7, 2019
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham

Study Description
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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 Intervention/treatment Phase
Malocclusion Procedure: Orthodontic Molar Protraction and PAOO Procedure: Orthodontic Molar Protraction Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
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.
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : December 30, 2023
Estimated Study Completion Date : December 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Orthodontic Molar Protraction
Molar protraction using orthodontic tooth movement alone
 Procedure: Orthodontic Molar Protraction
Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
Experimental: Orthodontic Molar Protraction and PAOO
Molar protraction using orthodontic tooth movement and adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO)
 Procedure: Orthodontic Molar Protraction and PAOO
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.


Outcome Measures
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Primary Outcome Measures :
  1. Linear millimeters of molar tooth movement [ Time Frame: From baseline to 3months ]
    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).

  2. Tooth angulation as measured radiographically [ Time Frame: From baseline to 3months ]
    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).


Secondary Outcome Measures :
  1. Periodontal probing depth [ Time Frame: From baseline to 3months ]
    Compare the periodontal probing depth (PD) at six sites per tooth at treated teeth 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).

  2. Periodontal clinical attachment level [ Time Frame: From baseline to 3months ]
    Compare the clinical attachment level (CAL) at six sites per tooth at treated teeth 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).

  3. Periodontal width of keratinized tissue [ Time Frame: From baseline to 3months ]
    Compare the width of keratinized tissue (KT) at up to two sites per tooth at treated teeth 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).

  4. Periodontal width of attached tissue [ Time Frame: From baseline to 3months ]
    Compare the width of attached tissue at up to two sites per tooth at treated teeth 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).

  5. Practitioner-assessed treatment outcomes [ Time Frame: From baseline to 3months ]
    Compare the practitioner-assessed esthetic outcomes using the pink esthetic score (PES) (Belser et al., 2009) 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). This score is a grid which assesses mesial and distal papilla fill on a 0-2 scale, curvature of facial gingiva on a 0-2 scale, level of facial gingiva on a 0-2 scale, and root convexity/soft tissue color and contour on a 0-2 scale for an overall maximum assessment of 10 for esthetics. A 10 score would be considered ideal esthetics and a 0 would be considered least desirable. Each individual component of the PES is summed to provide the ultimate PES score.

  6. Patient-assessed esthetic outcomes [ Time Frame: From baseline to 3months ]
    Compare the patient-assessed satisfaction with esthetic outcomes 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) using a visual analog scale from 0-100mm to determine the patients' assessment of their esthetic outcome.

  7. Patient centered post-operative discomfort assessment [ Time Frame: From baseline to 3months ]
    Compare treatment discomfort 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) using a visual analog scale from 0-100mm to determine the patients' assessment of the post-operative discomfort.

  8. Patient centered global treatment satisfaction [ Time Frame: From baseline to 3months ]
    Compare treatment overall treatment satisfaction 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) using a visual analog scale from 0-100mm to determine the patients' assessment of the patient's global assessment of treatment outcomes.

  9. Patient centered alteration of daily activities assessment [ Time Frame: From baseline to 3months ]
    Compare assessment of post-treatment change in daily activities 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) using a visual analog scale from 0-100mm to determine the patients' assessment of the post-operative changes to daily activities.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03794726


Contacts
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Contact: Maria L. Geisinger, DDS,MS 996-7011 mlgdds@uab.edu
Contact: Sarah Startley 205-975-8711

Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Maria L Geisinger, DDS,MS University of Alabama at Birmingham
More Information
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Responsible Party: Maria L. Geisinger, DDS, MS, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03794726    
Other Study ID Numbers: PAOO
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham:
Orthodontic tooth movement
Molar protraction
Periodontally accelerated osteogenic orthodontics
Patient-centered outcomes
Additional relevant MeSH terms:
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Malocclusion
Tooth Diseases
Stomatognathic Diseases