<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03794726</url>
  </required_header>
  <id_info>
    <org_study_id>PAOO</org_study_id>
    <nct_id>NCT03794726</nct_id>
  </id_info>
  <brief_title>Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery</brief_title>
  <acronym>PAOO</acronym>
  <official_title>A Prospective, Randomized Clinical Trial to Compare Orthodontic Molar Protraction With and Without Adjunctive Periodontally Accelerated Osteogenic Orthodontic (PAOO) Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare orthodontic molar protraction with and without adjunctive&#xD;
      periodontally accelerated osteogenic orthodontic (PAOO) surgery prior to orthodontic tooth&#xD;
      movement.&#xD;
&#xD;
      To the investigators' knowledge, this type of molar retraction in adult patients has not been&#xD;
      compared with and without the adjunctive use of PAOO for differences in clinical linear tooth&#xD;
      movement and patient centered outcomes (discomfort, change in daily activities, satisfaction&#xD;
      with esthetic outcomes) in a controlled study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research data and daily clinical observations reveal that molar protraction (forward&#xD;
      movement) in adult patients may be prolonged and ideal outcomes may not be achieved with&#xD;
      traditional orthodontic tooth movement. One method for enhancing orthodontic tooth movement&#xD;
      is the use of surgical access of the local site to initiate a regional tissue reaction to&#xD;
      induce trauma, which leads to a limited inflammatory healing process. This process is also&#xD;
      known as regional acceleratory phenomenon (RAP), which allows for more rapid bone turnover&#xD;
      and has been shown in other protocols to enhance orthodontic tooth movement. While PAOO has&#xD;
      been shown to rapidly increase tooth movement, to our knowledge, localized use of PAOO in&#xD;
      combination with molar protraction in adults has not been evaluated in a prospective trial&#xD;
      for differences in clinical outcomes (tooth movement time, adverse orthodontic outcomes,&#xD;
      periodontal and soft tissue defects) and patient-centered outcomes (pain, swelling, change in&#xD;
      daily activities, patient assessment of surgical benefit, and patient-assessed esthetics) in&#xD;
      a controlled study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">October 2023</start_date>
  <completion_date type="Anticipated">December 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Linear millimeters of molar tooth movement</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Tooth angulation as measured radiographically</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Periodontal probing depth</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal clinical attachment level</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal width of keratinized tissue</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periodontal width of attached tissue</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Practitioner-assessed treatment outcomes</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-assessed esthetic outcomes</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient centered post-operative discomfort assessment</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient centered global treatment satisfaction</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient centered alteration of daily activities assessment</measure>
    <time_frame>From baseline to 3months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Malocclusion</condition>
  <arm_group>
    <arm_group_label>Orthodontic Molar Protraction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Molar protraction using orthodontic tooth movement alone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Orthodontic Molar Protraction and PAOO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Molar protraction using orthodontic tooth movement and adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Orthodontic Molar Protraction and PAOO</intervention_name>
    <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.</description>
    <arm_group_label>Orthodontic Molar Protraction and PAOO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Orthodontic Molar Protraction</intervention_name>
    <description>Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.</description>
    <arm_group_label>Orthodontic Molar Protraction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  At least 18 years old&#xD;
&#xD;
          -  Must be a patient of the University of Alabama at Birmingham (UAB) Dental School&#xD;
&#xD;
          -  Able to read and understand informed consent document&#xD;
&#xD;
          -  One or more nonadjacent 1st or 2nd molar teeth that require protraction of ≥ 5 mm in&#xD;
             patients undergoing orthodontic tooth movement&#xD;
&#xD;
          -  Presence of periodontally healthy, non-carious neighboring teeth, healthy implants or&#xD;
             edentulous ridges on either side of the involved site(s)&#xD;
&#xD;
          -  No anticipated need for restorative care at the teeth to be treated during the study&#xD;
             period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Less than 18 years old&#xD;
&#xD;
          -  Smokers/tobacco users (&gt;10 cigarettes/day)&#xD;
&#xD;
          -  Patients with systemic pathologies or conditions contraindicating oral surgical&#xD;
             procedures or adversely affecting wound healing&#xD;
&#xD;
          -  Presence of active periodontal disease, caries, and/or periapical pathology at teeth&#xD;
             to be moved orthodontically&#xD;
&#xD;
          -  Previous orthodontic therapy involving molar protraction of teeth to be treated&#xD;
&#xD;
          -  Previous periodontal surgery at site(s) to be treated&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maria L Geisinger, DDS,MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Maria L. Geisinger, DDS,MS</last_name>
    <phone>996-7011</phone>
    <email>mlgdds@uab.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sarah Startley</last_name>
    <phone>205-975-8711</phone>
  </overall_contact_backup>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>October 9, 2018</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>April 7, 2023</last_update_submitted>
  <last_update_submitted_qc>April 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Maria L. Geisinger, DDS, MS</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Orthodontic tooth movement</keyword>
  <keyword>Molar protraction</keyword>
  <keyword>Periodontally accelerated osteogenic orthodontics</keyword>
  <keyword>Patient-centered outcomes</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Malocclusion</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03794726
org study id: PAOO
nct id: NCT03794726
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Linear millimeters of molar tooth movement
time frame: From baseline to 3months
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).
measure: Tooth angulation as measured radiographically
time frame: From baseline to 3months
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).
measure: Periodontal probing depth
time frame: From baseline to 3months
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).
measure: Periodontal clinical attachment level
time frame: From baseline to 3months
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).
measure: Periodontal width of keratinized tissue
time frame: From baseline to 3months
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).
measure: Periodontal width of attached tissue
time frame: From baseline to 3months
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).
measure: Practitioner-assessed treatment outcomes
time frame: From baseline to 3months
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.
measure: Patient-assessed esthetic outcomes
time frame: From baseline to 3months
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.
measure: Patient centered post-operative discomfort assessment
time frame: From baseline to 3months
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.
measure: Patient centered global treatment satisfaction
time frame: From baseline to 3months
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.
measure: Patient centered alteration of daily activities assessment
time frame: From baseline to 3months
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.
arm group label: Orthodontic Molar Protraction
arm group type: Active Comparator
description: Molar protraction using orthodontic tooth movement alone
arm group label: Orthodontic Molar Protraction and PAOO
arm group type: Experimental
description: Molar protraction using orthodontic tooth movement and adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO)
intervention type: Procedure
intervention name: Orthodontic Molar Protraction and PAOO
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.
arm group label: Orthodontic Molar Protraction and PAOO
intervention type: Procedure
intervention name: Orthodontic Molar Protraction
description: Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
arm group label: Orthodontic Molar Protraction
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maria L Geisinger, DDS,MS
role: Principal Investigator
affiliation: University of Alabama at Birmingham
last name: Maria L. Geisinger, DDS,MS
phone: 996-7011
email: mlgdds@uab.edu
last name: Sarah Startley
phone: 205-975-8711
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Maria L. Geisinger, DDS, MS
investigator title: Principal Investigator
mesh term: Malocclusion