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

Primary Purpose

Malocclusion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Orthodontic Molar Protraction and PAOO
Orthodontic Molar Protraction
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion focused on measuring Orthodontic tooth movement, Molar protraction, Periodontally accelerated osteogenic orthodontics, Patient-centered outcomes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Orthodontic Molar Protraction

    Orthodontic Molar Protraction and PAOO

    Arm Description

    Molar protraction using orthodontic tooth movement alone

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

    Outcomes

    Primary Outcome Measures

    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).
    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).

    Secondary Outcome Measures

    Periodontal probing depth
    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).
    Periodontal clinical attachment level
    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).
    Periodontal width of keratinized tissue
    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).
    Periodontal width of attached tissue
    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).
    Practitioner-assessed treatment outcomes
    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.
    Patient-assessed esthetic outcomes
    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.
    Patient centered post-operative discomfort assessment
    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.
    Patient centered global treatment satisfaction
    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.
    Patient centered alteration of daily activities assessment
    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.

    Full Information

    First Posted
    October 9, 2018
    Last Updated
    April 7, 2023
    Sponsor
    University of Alabama at Birmingham
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03794726
    Brief Title
    Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery
    Acronym
    PAOO
    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

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Alabama at Birmingham

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malocclusion
    Keywords
    Orthodontic tooth movement, Molar protraction, Periodontally accelerated osteogenic orthodontics, Patient-centered outcomes

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Orthodontic Molar Protraction
    Arm Type
    Active Comparator
    Arm Description
    Molar protraction using orthodontic tooth movement alone
    Arm Title
    Orthodontic Molar Protraction and PAOO
    Arm Type
    Experimental
    Arm Description
    Molar protraction using orthodontic tooth movement and adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO)
    Intervention Type
    Procedure
    Intervention Name(s)
    Orthodontic Molar Protraction and PAOO
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Orthodontic Molar Protraction
    Intervention Description
    Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
    Primary Outcome Measure Information:
    Title
    Linear millimeters of molar tooth movement
    Description
    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).
    Time Frame
    From baseline to 3months
    Title
    Tooth angulation as measured radiographically
    Description
    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).
    Time Frame
    From baseline to 3months
    Secondary Outcome Measure Information:
    Title
    Periodontal probing depth
    Description
    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).
    Time Frame
    From baseline to 3months
    Title
    Periodontal clinical attachment level
    Description
    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).
    Time Frame
    From baseline to 3months
    Title
    Periodontal width of keratinized tissue
    Description
    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).
    Time Frame
    From baseline to 3months
    Title
    Periodontal width of attached tissue
    Description
    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).
    Time Frame
    From baseline to 3months
    Title
    Practitioner-assessed treatment outcomes
    Description
    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.
    Time Frame
    From baseline to 3months
    Title
    Patient-assessed esthetic outcomes
    Description
    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.
    Time Frame
    From baseline to 3months
    Title
    Patient centered post-operative discomfort assessment
    Description
    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.
    Time Frame
    From baseline to 3months
    Title
    Patient centered global treatment satisfaction
    Description
    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.
    Time Frame
    From baseline to 3months
    Title
    Patient centered alteration of daily activities assessment
    Description
    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.
    Time Frame
    From baseline to 3months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    99 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria L. Geisinger, DDS,MS
    Phone
    996-7011
    Email
    mlgdds@uab.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sarah Startley
    Phone
    205-975-8711
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria L Geisinger, DDS,MS
    Organizational Affiliation
    University of Alabama at Birmingham
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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