MalocclusionPAOONCT03794726
Comparison of Orthodontic Molar Protraction With and Without Adjunctive Surgery
A study testing Orthodontic Molar Protraction and PAOO and Orthodontic Molar Protraction in people with Malocclusion, run by University of Alabama at Birmingham.
Trial summary
This study will compare orthodontic molar protraction with and without adjunctive periodontally accelerated osteogenic orthodontic (PAOO) surgery prior to orthodontic tooth movement. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Malocclusion
- What is being tested?
- Orthodontic Molar Protraction and PAOO and Orthodontic Molar Protraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to 30 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Sarah Startley contact
About this study
Official title: A Prospective, Randomized Clinical Trial to Compare Orthodontic Molar Protraction With and Without Adjunctive Periodontally Accelerated Osteogenic Orthodontic (PAOO) Surgery.
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.
Read the 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.
- Conditions
- Malocclusion
- Being tested
- Orthodontic Molar Protraction and PAOO, Orthodontic Molar Protraction
- Keywords
- Orthodontic tooth movement, Molar protraction, Periodontally accelerated osteogenic orthodontics, Patient-centered outcomes
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthodontic Molar Protraction and PAOOProcedure or surgery
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 ProtractionProcedure or surgery
Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
| Study group | Role | What they receive |
|---|---|---|
| Orthodontic Molar Protraction | Active comparator | Molar protraction using orthodontic tooth movement alone Receives: Procedure: Orthodontic Molar Protraction |
| Orthodontic Molar Protraction and PAOO | Experimental | Molar protraction using orthodontic tooth movement and adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO) Receives: Procedure: Orthodontic Molar Protraction and PAOO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: From baseline to 3months
Secondary outcomes (9)
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).
Measured: From baseline to 3months
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).
Measured: From baseline to 3months
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).
Measured: From baseline to 3months
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).
Measured: From baseline to 3months
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.
Measured: From baseline to 3months
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.
Measured: From baseline to 3months
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.
Measured: From baseline to 3months
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.
Measured: From baseline to 3months
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.
Measured: From baseline to 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study startJan 2027 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham
- Investigators
- Maria L Geisinger, DDS,MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794726
- Sponsor's protocol ID
- IRB-300002013
- Other IDs
- UAB-Perio
- Acronym
- PAOO
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2018
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Clinical Trial to Compare Orthodontic Molar Protraction With and Without Adjunctive Periodontally Accelerated Osteogenic Orthodontic (PAOO) Surgery.
- ClinicalTrials.gov ID
- NCT03794726
- Acronym / sponsor ID
- PAOO / IRB-300002013
- Conditions
- Malocclusion
- Keywords
- Orthodontic tooth movement, Molar protraction, Periodontally accelerated osteogenic orthodontics, Patient-centered outcomes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2029 (estimated)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontic Molar Protraction | Active comparator | Procedure: Orthodontic Molar ProtractionMolar protraction using orthodontic tooth movement alone |
| Orthodontic Molar Protraction and PAOO | Experimental | Procedure: Orthodontic Molar Protraction and PAOOMolar protraction using orthodontic tooth movement and adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO) |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orthodontic Molar Protraction and PAOOMolar 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. | Procedure or surgery | Orthodontic Molar Protraction and PAOO |
| Orthodontic Molar ProtractionStandard orthodontic molar protraction using traditional bands/brackets and orthodontic wires. | Procedure or surgery | Orthodontic Molar Protraction |
Primary outcome
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).
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).
9 secondary outcomes
Periodontal probing depth
Time frame: From baseline to 3months
Periodontal clinical attachment level
Time frame: From baseline to 3months
Periodontal width of keratinized tissue
Time frame: From baseline to 3months
Periodontal width of attached tissue
Time frame: From baseline to 3months
Practitioner-assessed treatment outcomes
Time frame: From baseline to 3months
Patient-assessed esthetic outcomes
Time frame: From baseline to 3months
Patient centered post-operative discomfort assessment
Time frame: From baseline to 3months
Patient centered global treatment satisfaction
Time frame: From baseline to 3months
Patient centered alteration of daily activities assessment
Time frame: From baseline to 3months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Startley contact
Maria L Geisinger, DDS,MS principal investigator
University of Alabama at Birmingham
Questions about this trial
What is this clinical trial studying?
A study testing Orthodontic Molar Protraction and PAOO and Orthodontic Molar Protraction in people with Malocclusion, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria L. Geisinger, DDS,MS (996-7011, mlgdds@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear millimeters of molar tooth movement (time frame: From baseline to 3months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.