A Prospective, Randomized Clinical Trial to Compare Orthodontic Molar Protraction With and Without Adjunctive Periodontally Accelerated Osteogenic Orthodontic (PAOO) Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Tooth angulation as measured radiographically
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Orthodontic Molar Protraction
Molar protraction using orthodontic tooth movement alone
干预措施: Orthodontic Molar Protraction (Procedure)
Orthodontic Molar Protraction and PAOO
Molar protraction using orthodontic tooth movement and adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO)
干预措施: Orthodontic Molar Protraction and PAOO (Procedure)
结局指标
主要结局
Tooth angulation as measured radiographically
时间窗: 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).
Linear millimeters of molar tooth movement
时间窗: 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).
次要结局
- Periodontal clinical attachment level(From baseline to 3months)
- Patient-assessed esthetic outcomes(From baseline to 3months)
- Periodontal width of keratinized tissue(From baseline to 3months)
- Practitioner-assessed treatment outcomes(From baseline to 3months)
- Periodontal probing depth(From baseline to 3months)
- Patient centered post-operative discomfort assessment(From baseline to 3months)
- Patient centered alteration of daily activities assessment(From baseline to 3months)
- Periodontal width of attached tissue(From baseline to 3months)
- Patient centered global treatment satisfaction(From baseline to 3months)
研究者
Maria L. Geisinger, DDS, MS
Principal Investigator
University of Alabama at Birmingham