Evaluation of Hyaluronic Acid and I-PRF Mixture for Intra-articular Injection Following Arthrocentesis in The Management of TMJ Reducible Disc Displacement: A Four Arm Comparative Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Intensity of pain
研究概览
简要总结
The aim of this study is to evaluate the efficacy of hyaluronic acid and I-PRF mixture for intra-articular injection following arthrocentesis in the management of TMJ reducible disc displacement.
详细描述
The purpose of this four-arm comparative clinical trial is to evaluate the efficacy of a combined intra-articular injection of Hyaluronic Acid (HA) and Injectable Platelet-Rich Fibrin (i-PRF) following arthrocentesi in patients suffering from temporomandibular joint (TMJ) reducible disc displacement.
All eligible participants will undergo standard TMJ arthrocentesis using Ringer's lactate solution to flush out inflammatory mediators and disrupt intra-articular adhesions.
Patients will be randomly assigned to one of four treatment protocols to compare therapeutic outcomes:
Group I: Arthrocentesis alone (Control). Group II: Arthrocentesis followed by intra-articular injection of Hyaluronic Acid only.
Group III: Arthrocentesis followed by intra-articular injection of a Hyaluronic Acid and Betamethasone mixture.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 45 years.
- •Patients with disc displacement with reduction in any of the TMJs.
- •arthralgia.
- •Limited unassisted mouth opening.
- •Co-operative patients.
排除标准
- •Patients with previous history of TMJ minimally invasive interventions.
- •Patients with autoimmune or connective tissue diseases affecting the joints.
- •Patients with neurological disorders.
- •Patients with a history of condylar fractures or ankylosis.
- •Patients with psychological problems.
- •Patients receiving non-steroidal anti-inflammatory drugs within 48 hours preoperatively, or systemic use of corticosteroids within 2 weeks.
- •Patients on anticoagulants, suffering from platelet function disorders or fibrinogen deficiency.
- •Patients with moderate to severe myogenic pain.
研究组 & 干预措施
Group II: Arthrocentesis followed by hyaluronic acid injection
干预措施: Arthrocentesis followed by hyaluronic acid injection (Procedure)
Group III: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture
干预措施: Arthrocentesis followed by injection of hyaluronic acid and betamethasone mixture (Procedure)
Group IV: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture
干预措施: Arthrocentesis followed by injection of hyaluronic acid and I-PRF mixture (Procedure)
Group I: Arthrocentesis only
干预措施: 18 joints that receive arthrocentesis using 100 ml of ringer lactate solution (Procedure)
结局指标
主要结局
Intensity of pain
时间窗: preoperative, one week, one month, 3 months and 6 months
Pain intensity will be evaluated subjectively using Numeric Rating Scale from zero to 10 zero indicates no pain at all 10 indicates the worst pain ever
Maximum interincisal opening, lateral and protrusive movements
时间窗: preoperative, one week, one month, 3 months and 6 months
1. Maximum interincisal opening: the distance in millimeters between the incisal edges of the central incisors in vertical direction at maximum pain free mouth opening, measured using a caliper. 2. Range of lateral and protrusive movements: the distance in millimeters between the upper and lower midlines in horizontal direction on lateral and protrusive movements, measured using a caliper.
次要结局
- Clicking(preoperative, one week, one month, 3 months and 6 months)