Evaluation of Anterior Repositioning Guided Splint Combined With or Without Injectable Platelet-rich Fibrin in Treatment of TMJ Internal Derangement.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Maximum mouth opening
研究概览
简要总结
The study aims to evaluate clinically and radiographically the effectiveness of arthrocentesis and injection of I-PRF with wearing ARS in comparison to arthrocentesis and ARS only.
详细描述
The patient will be seated at a 45° angle with the head turned toward the unaffected side. After preparing and disinfecting the target site with betadine, two points will be marked over the affected joint. Local anesthesia will be administered to block the auriculotemporal nerve. Using 19-gauge needles, the superior joint space will be distended with 2-3 ml of Ringer's solution. Another needle will be inserted into the distended compartment near the articular eminence to facilitate solution flow. Lactated Ringer's solution, connected to one needle, will be infused with sufficient pressure (200 mL in 15-20 minutes) to release adhesions. Following the removal of one needle, 2 ml of injectable platelet-rich fibrin (PRF) will be injected into the superior joint space.
For the preparation of injectable PRF, 20 ml of the patient's blood will be drawn and divided into two 10 ml vaccutainers. After centrifugation, the obtained PRF will be aspirated into a 5 ml syringe, and 1.5 to 2 ml of PRF will be injected into the superior joint space.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18 years and older.
- •History of unilateral or bilateral disc displacement without reduction (DDwoR) of the temporomandibular joint (TMJ) confirmed by MRI.
- •Presence of TMJ pain and restricted maximum mouth opening.
- •No improvement with conservative treatment.
- •Absence of MRI contraindications.
排除标准
- •Patients having any systemic disease that could interfere with the TMJ treatment or assessment.
- •Patients having previous TMD treatment modalities or previous TMJ surgery.
- •Patients with a previous history of oral and or maxillofacial trauma.
- •Patients that are contraindicated to perform MRI.
- •Completely or partially edentulous patients were also excluded.
结局指标
主要结局
Maximum mouth opening
时间窗: First week, first month, third months, and sixth months
Maximum Mouth Opening was determined by measuring the distance between the incisal edges of the upper and lower incisors. In Millimeter (mm)
Pain score
时间窗: First week, first month, third months, and sixth months
Using Visual Analogue Scale (VAS)
次要结局
- Right and left lateral excursion(First week, first month, third months, and sixth months)
研究者
Mahmoud Mohammed Mahmoud Nasef
Demonstrator at the Department of oral and Maxillofacial Surgery
Al-Azhar University