Acceleration of Tooth Movement Using PRP and Photobiomodulation With Clear Aligners
2026年8月26日 更新者：Arij Lutf Abdulrhman Abdul Majid、Sana'a University
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
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.
研究概览
地位
尚未招聘
条件
详细说明
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.
研究类型
介入性
注册 (估计的)
42
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Naela M Al-mogahed, Prof
- 电话号码：+967777962002
- 邮箱：almogahed2000@yahoo.com
学习地点
-
-
Sanaa Governorate
-
Sanaa、Sanaa Governorate、也门、009671
- Faculty of Dentistry Sanaa university
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Clear Aligner + Photobiomodulation
under a reduced wear-time framework.
|
extra-oral application of photobiomodulation (PBM) Therapy to the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement
Clear aligner worn for 22-hour on the first day of each aligner stage, followed by a daily wear duration of 12-hour per day for the remaining period in combination with acceleration modalities
|
|
实验性的：Clear Aligner + Plasma Injection
under a reduced wear-time framework
|
Clear aligner worn for 22-hour on the first day of each aligner stage, followed by a daily wear duration of 12-hour per day for the remaining period in combination with acceleration modalities
local submucosal injection of Autologous Platelet Rich Plasma (PRP) into the targeted alveolar site to evaluate its clinical effectiveness in accelerating orthodontic tooth movement
|
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有源比较器：Clear Aligner Control Group
without any accelerator intervention
|
Clear aligners worn for the standard conventional duration of 22-hour per day without additional acceleration interventions
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rate of clinical tooth movement via intraoral digital scans
大体时间：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.
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Every 4 weeks from baseline up to 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Root apex displacement
大体时间：Baseline and 6 months
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Assessment of root apex displacement in millimeters using CBCT superimposition
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Baseline and 6 months
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Patient-Reported Pain Level
大体时间：At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.
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Pain intensity is evaluated using the Visual Analog Scale from 0 to 10, where 0 indicates no pain and 10 represents the worst possible pain.
Higher scores indicate worse pain.
|
At baseline, 24 hours, 48 hours, day 3, day 7 and day at aligner change up to 6 months.
|
|
Root resorption
大体时间：Baseline and 6 months
|
Assessment of root resorption in millimeters using CBCT superimposition
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Baseline and 6 months
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Peri-tooth alveolar bone density
大体时间：Baseline and 6 months
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Assessment of peri-tooth alveolar bone density changes in Hounsfield Unit (HU) using CBCT superimposition.
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Baseline and 6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Arij L Abdulmajid, MSc、Sanaa University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年9月1日
初级完成 (估计的)
2027年4月1日
研究完成 (估计的)
2027年5月1日
研究注册日期
首次提交
2026年8月17日
首先提交符合 QC 标准的
2026年8月26日
首次发布 (实际的)
2026年8月31日
研究记录更新
最后更新发布 (实际的)
2026年8月31日
上次提交的符合 QC 标准的更新
2026年8月26日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.