Comparison of the Efficacy of Single and Double Puncture Arthrocentesis in Treatment of Temporomandibular Joint Disc Displacement Without Reduction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)
研究概览
简要总结
The aim of the present study was to compare the treatment efficacy of single puncture arthrocentesis (SPA) and double puncture arthrocentesis (DPA) techniques in Temporomandibular joint (TMJ) disc displacement without reduction (DDwoR).
详细描述
Study sample consisted of 36 patients with DDwoR. 18 patients received SPA procedure and included in SPA group. The other 18 patients received DPA procedure and included in DPA group.
Double puncture arthrocentesis technique:
Posterior puncture method was used as described by Alkan and Etoz. for DPA. A straight line was drawn with a marker pen along the skin from the middle portion of the auricular tragus to the lateral chantus. The first puncture point was marked 10 mm anterior and 2 mm inferior to the tragus and the second 7 mm anterior and 2 mm inferior to the tragus. After local anesthesia, upper joint cavity was irrigated with 200 mL of Lactated Ringer's (RL) solution by inserting two 21- gauge needle. At the end of the procedure, after withdrawn of one of the needles, 1 mL of sodium hyaluronate (SH) was injected into the upper TMJ compartment through the other needle.
Single Puncture Arthrocentesis Technique:
SPA was performed with one needle (SPA Type-1 according to Senturk and Cambazoglu). The first reference point in DPA was used as the needle entry point fort he SPA. With this technique, the inflow and outflow of solution were provided through the same cannula and lumen of one 21-gauge needle as described by Guarda-Nardini et al. The joint was irrigated with 200 mL of RL solution under high pressure. At the end of the procedure1 mL of SH was injected through the needle.
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
- 21 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Temporomandibular joint (TMJ) disc displacement without reduction.
- •Restricted mouth opening
- •Exclusion criteria:
- •History of systemic disease effecting TMJ.
- •History of previous TMJ surgery
排除标准
- 未提供
结局指标
主要结局
The Rate of Pain on Function (PoF) assessed by Numerical Rating Scale (NRS)
时间窗: at 6th month (t4)
Patients rated their pain on function (pain during chewing or speaking etc.) on a Numeric Rating Scale (NRS) (0-10 where 0 is no pain and 10 is the worst pain imaginable)
The measurement of pain-free maximum mouth opening (MMO) in millimeters
时间窗: at 6th month (t4)
Pain-free MMO was measured as the distance between the incisal edges of the upper and lower incisors while patient's mouth is open as possible without any assistance and without pain. Three measurements were performed, and their average is recorded.
次要结局
- Measurement of the easiness of the procedure to the operator by using Visual Analog Scale (VAS)(at 1st day (At the end of the procedure))
- The rate of treatment tolerability assessed by 5-point Likert-type scale(6th month)
- Rate of perceived effectiveness of the treatment by using 5-point Likert-type scale(at 6th month)
- Measurement of Lateral Movement of the mandible towards the affected Temporomandibular joint (TMJ) in millimeters(at 6th month (t4))
- The rate of pain at rest (PaR) assessed by Numerical Rating Scale (NRS)(at 6th month (t4))
- Measurement of Duration of the Procedure in Minutes(at 1st day (At the end of the procedure))
- The rate of chewing efficiency by using Visual Analog Scale (VAS)(at 6th month (t4))
- Measurement of Lateral Movement of the mandible away from the affected Temporomandibular joint (TMJ) in millimeters(at 6th month (t4))
- Measurement of protrusive movement of the mandible in millimeters(at 6th month (t4))
研究者
Fatih TASKESEN
Head of Dept. Oral and Maxillofacial Surgery
Erzincan University