COMPARISON OF ARTHROCENTESIS, INJECTABLE PLATELET RICH FIBRIN AND COMBINATION OF THE TWO IN PATIENTS WITH UNILATERAL TEMPOROMANDIBULAR JOINT INTERNAL DERANGEMENT: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- evaluate and compare three different methods of management i.e., arthrocentesis, i-PRF injection, and a combination of the two in unilateral temporomandibular disorder in terms of TMJ pain relief, based on VAS scale evaluated after the 3rd month post intervention.
研究概览
简要总结
Temporomandibulardisorders appear to be common problem and have major impact in the quality ofthe life. Various management modalities such as splints, physiotherapy,arthrocentesis, intra-articular injections of agents like HA, PRP and i-PRF havebeen used for the relief of the symptoms primarily pain and reduced mouthopening. Arthrocentesisis minimal invasive procedure that can be performed without significantcomplications. The significant positive clinical outcomes, cost effectivenessand the minimal use of the armamentarium has increased its application inmanagement of TMD. The development of the i-PRF and the studies related toi-PRF in the patients with TMD showed significant positive effects in reductionof the symptoms. i-PRF canbe easily prepared and is obtained from the patient’s own blood with no significantintra-operative and post intervention complication such as allergic reactionsdue to the blood concentrate used. Hence, itseems logical to use i-PRF individually or arthrocentesis combined with i-PRF. Hence, the study is being conducted to compare thethree different modalities of management in the patients with temporomandibulardisorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: More than 18 years or less than or equal to 50 years.
- •Unilateral temporomandibular disorder (Wilkes II, III, IV) Painful TMD Occasional difficulty in mouth opening.
排除标准
- •Age18 or less and more than 50 Pregnant female Autoimmune diseases such as osteoarthritis and rheumatoid arthritis Patient allergic to local anaesthesia Patient in whom magnetic resonance imaging (MRI) is contraindicated Patient with history of TMJ surgery Patient with the congenital or developmental disorder of TMJ Benign or malignant TMJ lesions Patients refusing to attend all scheduled visits.
结局指标
主要结局
evaluate and compare three different methods of management i.e., arthrocentesis, i-PRF injection, and a combination of the two in unilateral temporomandibular disorder in terms of TMJ pain relief, based on VAS scale evaluated after the 3rd month post intervention.
时间窗: 10 th day ,1 month and 3 months
次要结局
- •To assess the change in maximum inter-incisal mouth opening(•To assess the change in lateral and protrusive movement)