Evaluation Of The Clinical Efficacy Of Liquid Platelet Rich Fibrin Application In Painful Temporomandibular Joint Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Visual Analog Scale improvement over time
研究概览
简要总结
This randomized clinical trial aims to evaluate the efficacy of liquid platelet-rich fibrin administration at different Wilkes stages.
详细描述
Thirty six patients with unilateral painful internal derangement (ID) (Wilkes' 3-4-5) were included. Patients were divided into 2 groups. In group 1 were treated with only artrosythesis. In group 2 were treated with artrosythesis and liquid platelet rich fibrin. In group 2, patients were injected with 1.5-2cc of liquid platelet-rich fibrin within the superior joint space at operation day. Pain and subjective dysfunction were recorded using a visual analog scale and Helkimo index at operation day and tenth day, one month later and 3 months later.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral internal temporomandibular disorder
- •localized temporomandibular joint pain
- •Scoring 3 and above in Wilke's classification.
排除标准
- •Autoimmune diseases
- •Significant mechanical obstruction that prevents mouth opening
- •Acute capsulitis,
- •Benign or malignant temporomandibular joint lesions
- •Neurological disorders,
- •Blood diseases and coagulation disorders
- •Patients with a history of allergies or anaphylactic shock.
结局指标
主要结局
Visual Analog Scale improvement over time
时间窗: operation time, tenth day, end of first month, end of third month
The patient gives his pain a value between 0-10. The patients' pain scores were recorded by using a 10 cm visual analog scale (VAS) from 0, which represents no pain, to 10, which represents the worst possible pain. Since lower scores represent better health, the amount of improvement between sessionsis calculated by subtracting the next score from the previous score.
Maximum incisal opening improvement over time
时间窗: operation time, tenth day, end of first month, end of third month
It is the vertical distance between the incisal teeth when the patient opens his mouth to the maximum. It is measured with the help of a caliper. Since higher scores represent better health, the amount of improvement between sessionsis calculated by subtracting the previous score from the next score.
Helkimo Clinical Dysfunction Score improvement over time
时间窗: operation time, tenth day, end of first month, end of third month
In the Helkimo Clinical Dysfunction Index, the maximum mandibular movement limits are measured vertically and laterally. In addition, TMJ function, muscle pain, TMJ region pain and mandibular motion pain are evaluated separately. After all these evaluations, all the scores given are summed up and a total dysfunction score is obtained. If this total score is 0, the dysfunction is completely healed. If the total score is between 1 and 4, mild dysfunction, between 5 and 9, moderate dysfunction, and between 10 and 25 severe dysfunction. Since lower scores represent better health, the amount of improvement between sessionsis calculated by subtracting the next score from the previous score.
次要结局
未报告次要终点
研究者
Burcu Gürsoytrak
Assistant Professor
Aydin Adnan Menderes University