Malocclusion Clinical Trial
— PAOOOfficial 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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | December 30, 2026 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Alabama at Birmingham |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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). | From baseline to 3months | |
Secondary | 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). | From baseline to 3months | |
Secondary | 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). | From baseline to 3months | |
Secondary | 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). | From baseline to 3months | |
Secondary | 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. | From baseline to 3months | |
Secondary | 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. | From baseline to 3months | |
Secondary | 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. | From baseline to 3months | |
Secondary | 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. | From baseline to 3months | |
Secondary | 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. | From baseline to 3months |
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