Injection of Liquid Phase Concentrated Growth Factor Versus Conventional Arthrocentesis in Management of Temporomandibular Disc Displacement: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Assess and comparing the pain of both groups
研究概览
简要总结
This study aims to rigorously assess the effectiveness of LPCGF in the management of internal disc displacement in patients with TMD through a randomized clinical trial. By comparing LPCGF therapy with conventional arthrocentesis, this research looks to provide robust evidence on the efficacy, safety, and potential role of (LPCGF) as an alternative therapeutic choice for IDD.
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)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Adults aged 18-45 years.
- •Patients scored as (ASA I).9
- •Presence of complete or nearly complete set of natural dentition with Angle class I occlusion.
- •Diagnosed with unilateral involvement of disc displacement, according to the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).10
- •Symptoms include one or more of the following: pain, joint sounds, and limited mandibular movement (Maximum Mouth Opening< 40mm)
- •No prior surgical intervention for TMD.
- •Patient's willingness to participate and follow the study protocol.
排除标准
- •1. TMJ pathology related to mechanical deformities
- •Psychiatric problems or presence of systemic diseases that may affect healing (e.g., uncontrolled diabetes, autoimmune disorders, hematologic or neurologic disorders, inflammatory or connective tissue disorders as well as rheumatological or previous infectious diseases, head and neck cancer).
- •Patient unwilling or has contraindication to MRI
- •Previous injections or surgical interventions of the TMJ.
- •Concurrent use of anticoagulants or anti-inflammatory medications within the last 30 days.
- •Pregnant or breastfeeding women.
- •History of trauma or infection in the TMJ region.
- •Allergy to local anesthetics or other components used in the study.
- •Patients diagnosed with (Disc Displacement with reduction with no pain or limited mandibular movements).
研究组 & 干预措施
Group A
16 patients have anterior disc displacement with or without reduction will be treated with injection of liquid phase concentrated growth factor
干预措施: Liquid Phase Concentrated Growth Factor (Procedure)
Group B
16 patients have anterior disc displacement with or without reduction will be treated with conventional arthrocentesis
干预措施: Conventional arthrocentesis (Procedure)
结局指标
主要结局
Assess and comparing the pain of both groups
时间窗: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
measured using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst pain)
Assess and comparing the mouth opening of both groups
时间窗: Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.
measured in millimeters (Maximum inter-incisal opening measured by the distance in millimeters between the incisal edges of the upper and lower central incisors in vertical direction at maximum pain free mouth opening) by using caliper. and comparing the results of both groups
次要结局
- Joint sounds(Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.)
- Mandibular deviation during mouth opening.(Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.)
- Lateral and protrusive movements(Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention)
- tenderness on palpation(Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.)
- TMD symptoms(Assessed at baseline (before treatment),1week, 1 month, 3 months, and 6 months after the intervention.)
研究者
Mohamed Ali Habib
Teaching assistant
Horus University