Effect of Platelet Concentration in Platelet-Rich Plasma on Prolotherapy Outcomes in Temporomandibular Joint Subluxation: A Double-Blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- TMJ Pain on Function
研究概览
简要总结
This study is about a treatment for a jaw condition called temporomandibular joint (TMJ) subluxation. In this condition, the jaw can move too far forward during mouth opening, which may cause repeated jaw locking and problems with normal function.
The treatment being studied is platelet-rich plasma (PRP) injections. PRP is made from a person's own blood and may help improve joint stability and reduce symptoms.
In this study, 40 adults with TMJ subluxation were randomly assigned to receive PRP with either a lower or higher platelet concentration. Each participant received 2 injections, given 2 weeks apart.
The study measured jaw pain, how often locking happened, mouth opening, and joint clicking before treatment, after 6 months, and after 5 years.
The goal of this study is to find out whether the amount of platelets in PRP changes how well this treatment works.
详细描述
This prospective, double-blinded, parallel-group randomized clinical trial was conducted to evaluate whether platelet concentration influences the clinical efficacy of platelet-rich plasma (PRP) prolotherapy in the management of temporomandibular joint (TMJ) subluxation. TMJ subluxation is characterized by recurrent episodes of excessive anterior translation of the mandibular condyle beyond the articular eminence, often resulting in transient jaw locking and functional impairment.
A total of 40 adult patients (≥18 years) diagnosed with TMJ subluxation according to the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD), supported by imaging evidence, were enrolled and randomly allocated in a 1:1 ratio into two groups: low-concentration PRP (L-PRP) and high-concentration PRP (H-PRP). PRP was prepared using standardized centrifugation protocols (1,500 rpm for L-PRP and 3,200 rpm for H-PRP). All participants received two intra-articular and pericapsular injections separated by a 2-week interval.
The primary outcomes were TMJ pain on function, assessed using a visual analog scale (VAS), and frequency of joint locking (episodes/day). Secondary outcomes included maximal mouth opening (MMO, mm) and presence of joint clicking. Outcomes were assessed at baseline, 6 months, and 5 years following treatment.
The study aimed to determine whether variations in platelet concentration affect clinical outcomes of PRP prolotherapy and to provide evidence for optimizing PRP preparation protocols in the management of TMJ subluxation.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors were blinded to group allocation. The clinician performing the intervention was not blinded due to the nature of the procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged ≥ 18 years -
排除标准
- •patients aged < 18 years
研究组 & 干预措施
Low Platelet Concentration PRP (L-PRP)
Patients received prolotherapy using platelet-rich plasma with low platelet concentration.
干预措施: Low Platelet Concentration PRP (L-PRP) (Procedure)
High Platelet Concentration PRP (H-PRP)
Patients received prolotherapy using platelet-rich plasma with high platelet concentration.
干预措施: High Platelet Concentration PRP (L-PRP) (Procedure)
结局指标
主要结局
TMJ Pain on Function
时间窗: Baseline, 6 months, and 5 years
Pain during jaw function measured using a visual analog scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates worst pain.
Frequency of TMJ locking
时间窗: Baseline, 6 months, and 5 years
Frequency of locking, expressed as number of episodes per day
次要结局
- Maximum mouth opening (MMO)(Baseline, 6 months, and 5 years)
- Presence of joint clicking(Baseline, 6 months, and 5 years)
研究者
radwan saleh algabri
Assistant Professor of Prosthodontics
IBB University