Evaluation and Comparison of Acceleration of Tooth Movement Using Platelet-Rich Plasma (PRP) and Photobiomodulation (PBM) With Clear Orthodontic Appliances (Aligners): A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Rate of clinical tooth movement via intraoral digital scans
研究概览
简要总结
This study compares the effectiveness of two adjunct therapies- photobiomodulation (low-level laser therapy) (PBM) and localized platelet-rich plasma (PRP) injections in accelerating orthodontic tooth movement. Participants receiving clear aligner therapy will be randomly assigned to one of three groups: clear aligners with PBM, clear aligners with PRP, or clear aligners alone (control group). The goal is to evaluate the efficiency, tooth movement tracking and safety.
详细描述
This randomized controlled clinical trial evaluates the acceleration orthodontic tooth movement using two adjunct biological stimulation modalities in patients under going clear aligners therapy participant are allocated into three groups:
- Clear aligner + photobiomodulation (PBM) : receives low-level laser therapy at specific intervals to stimulate cellular turnover and bone remodeling
- Clear aligner +platelet-rich plasma (PRP) :receives localized autologous injections in the target tooth movement area to facilitate biological response
- Clear aligners alone: (control group )receiving standard clear aligners treatment without additional interventions.
Outcomes will be evaluated periodically using digital intra-oral scanning to measure tracking, accuracy, rate of orthodontic tooth movement, and soft tissue - periodontal health throughout the active treatment period.
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)
盲法说明
This is a single-blind study. the outcome assessor and data analyst are blinded to group allocations. blinding the clinician and participants was not feasible due to the nature of PRP and photobiomodulation application.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18- 25 years requiring clear aligner therapy
- •good oral hygiene and health periodontal status
- •full permanent dentition (excluding third molars)
- •willingness to comply with clear aligner wear schedules and follow -up visits.
排除标准
- •history of previous orthodontic treatment
- •Systemic diseases or conditions affecting bone metabolism
- •Ongoing pharmacological treatment able to influence orthodontic movement (e.g. prostaglandin inhibitors or biphosphonates)
- •Active periodontal disease or poor oral hygiene
- •history of photosensitivity or diseases triggered by light exposure
- •contraindication to PRP blood extraction
研究组 & 干预措施
Clear Aligner + Plasma Injection
under a reduced wear-time framework
干预措施: Platelet Rich Plasma (PRP) injection (Biological)
Clear Aligner + Plasma Injection
under a reduced wear-time framework
干预措施: clear aligner(12-hour wear protocol) (Device)
Clear Aligner + Photobiomodulation
under a reduced wear-time framework.
干预措施: photobiomodulation (PBM) Therapy (Device)
Clear Aligner + Photobiomodulation
under a reduced wear-time framework.
干预措施: clear aligner(12-hour wear protocol) (Device)
Clear Aligner Control Group
without any accelerator intervention
干预措施: Clear aligner(22-hour wear protocol) (Device)
结局指标
主要结局
Rate of clinical tooth movement via intraoral digital scans
时间窗: Every 4 weeks from baseline up to 6 months
Quantitative measurement of cumulative linear displacement and dental crown movement (in millimeters) calculated after every 2- aligners sequence (every 4 weeks) measurement will be obtained using digital intra-oral scan superimposed across all three study groups.
次要结局
- Root apex displacement(Baseline and 6 months)
- Patient-Reported Pain Level(At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.)
- Root resorption(Baseline and 6 months)
- Peri-tooth alveolar bone density(Baseline and 6 months)
研究者
Arij Lutf Abdulrhman Abdul Majid
PhD student
Sana'a University