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临床试验/NCT07750483
NCT07750483已完成不适用

Efficacy of Intra-Articular Hyaluronic Acid Combination Injections for Temporomandibular Joint Internal Derangement: A Clinical and MRI Based Randomized Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Joint Clicking

研究概览

简要总结

This randomized controlled clinical trial aims to compare the clinical and magnetic resonance imaging (MRI) outcomes of three intra-articular injection protocols for the treatment of temporomandibular joint (TMJ) internal derangement with reduction. Sixty patients who remain symptomatic despite conservative therapy will be randomly assigned to receive hyaluronic acid combined with platelet-rich plasma (PRP), tenoxicam, or corticosteroid. Clinical outcomes including pain intensity, maximum mouth opening, and joint clicking, together with MRI findings, will be evaluated over a 6-month follow-up period.

详细描述

Temporomandibular joint (TMJ) internal derangement is a common disorder associated with pain, joint sounds, and limitation of mandibular function. Although conservative treatment is considered the first-line therapy, some patients continue to experience persistent symptoms requiring minimally invasive intervention.

Hyaluronic acid (HA) is widely used for intra-articular injection because of its lubricating and anti-inflammatory properties. Platelet-rich plasma (PRP) has demonstrated regenerative potential through the release of growth factors that may promote tissue healing. Corticosteroids provide potent anti-inflammatory effects but may adversely affect cartilage with repeated use, whereas tenoxicam is a long-acting nonsteroidal anti-inflammatory drug with favorable analgesic and anti-inflammatory properties.

This prospective randomized controlled clinical trial will compare three treatment protocols:

Hyaluronic acid combined with tenoxicam Hyaluronic acid combined with platelet-rich plasma Hyaluronic acid combined with corticosteroid

Sixty patients diagnosed with TMJ internal derangement with reduction confirmed by MRI and unresponsive to conservative treatment will be randomly allocated in a 1:1:1 ratio to one of the three intervention groups. Clinical assessments will include pain intensity using the Visual Analog Scale (VAS), maximum mouth opening (MMO), and joint clicking at baseline, 1 week, 1 month, 3 months, and 6 months. MRI examinations will be performed at baseline and 6 months to evaluate structural changes within the joint

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 45 years. TMJ internal derangement with reduction confirmed by MRI. Early or intermediate disease according to Wilkes classification. Painful TMJ with clicking, with or without limited mouth opening. Persistent symptoms despite conservative treatment. Able and willing to provide informed consent and attend follow-up visits.

排除标准

  • nflammatory or connective tissue disorders. Previous TMJ surgery. Neurological disorders. Previous TMJ injection within the last 6 months. Fibrous or bony ankylosis/adhesion. Internal derangement without reduction. Psychological disorders affecting study participation.

研究组 & 干预措施

Hyaluronic Acid + Tenoxicam

Experimental

Participants receive a single intra-articular injection of hyaluronic acid combined with tenoxicam into the affected temporomandibular joint.

干预措施: intraarticular injection in TMJ (Procedure)

Hyaluronic Acid + Platelet-Rich Plasma (PRP)

Experimental

Single intra-articular injection of hyaluronic acid combined with autologous platelet-rich plasma.

干预措施: intraarticular injection in TMJ (Procedure)

hyaluronic acid combined with corticosteroid.

Experimental

Single intra-articular injection of hyaluronic acid combined with corticosteroid.

干预措施: intraarticular injection in TMJ (Procedure)

结局指标

主要结局

Joint Clicking

时间窗: Baseline, 1 week, 1 month, 3 months, and 6 months

Presence or absence of TMJ clicking will be recorded during mandibular movement.

MRI Evaluation

时间窗: Baseline and 6 months

Magnetic resonance imaging will assess changes in disc position, joint morphology, and other structural characteristics following treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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