Evaluation of Computer-guided Visco Supplementation in the Management of Internal Derangement of Temporomandibular Joint (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in TMJ dysfunction
研究概览
简要总结
Background: The intra-articular injection is considered the first line of minimally invasive treatment in TMJ-ID patients who do not respond to conservative treatment. Image-guided puncture technique has emerged to add safety, reliability, convenience, and decrease the need for correcting the puncture point.
Aim of the study: To evaluate the feasibility and clinical outcomes of computer-guided superior joint space injection of sodium hyaluronate in the treatment of temporomandibular joint disorder (TMJ-ID) compared with conventional injection
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
- None
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 diagnosed with internal derangement according to Wilkins stage I and II.
- •Patients who would not respond to conservative treatment as a first line of treatment.
排除标准
- •Patients with Wilkins stage III, IV, V.
- •History of mandibular fracture.
- •Lactating, pregnant or planning pregnancy women.
- •Known hypersensitivity to hyaluronic acid or clear biocompatible photopolymer resin.
研究组 & 干预措施
Study Group
干预措施: Computer guided sodium hyaluronate injections (Other)
Control
干预措施: conventional sodiumhyaluronate injections (Other)
结局指标
主要结局
Change in TMJ dysfunction
时间窗: Baseline, 1 month, and 3 months
A modified version of Helkimo's clinical dysfunction index (Di) is be calculated to assess the TMJ dysfunction as follows: * Maximum unassisted mouth opening range: Opening range will be determined by asking the patient to gently open mouth and measure the distance between upper and lower central incisors. * Mandibular deviation during opening: Patients will be asked to open mouth gently and deviation will be noted between maxillary and mandibular midline, score 0 - if \<2 mm, score 1 - if 2-5 mm, and score 5 - if \>5 mm
change in pain score
时间窗: Baseline,1 months, and 3 months
Pain level was determined by the patient's self-assessment using a visual analog scale (VAS) from zero to 10 ("0" is pain-free and "10" is severe intolerable pain).
次要结局
- Duration of operation(Baseline)
- Number of Needle Relocation(Baseline)
研究者
Hams Hamed Abdelrahman
Assistant Lecturer of Dental Public Health and biostatistical consultant
Alexandria University