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临床试验/NCT06948682
NCT06948682已完成不适用

Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study

King Khalid University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年1月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Change in TMJ Pain Intensity (VAS Score)

研究概览

简要总结

The study "Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study" investigated the efficacy of occlusal therapy in managing degenerative temporomandibular joint (TMJ) disorders. Conducted over 6 months with 150 patients, it compared three groups: occlusal therapy (Group 1), conventional treatment (Group 2), and routine care (Group 3). Group 1 showed significant improvements, including a 65% pain reduction, 51% better jaw function, slower joint degeneration, 64% less muscle tension, 24% improved jaw mobility, and enhanced quality of life, outperforming the other groups. The findings support occlusal therapy's role in multidisciplinary TMJ management, though long-term studies are needed.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 to 65 years
  • Clinical diagnosis of moderate to severe degenerative temporomandibular joint (TMJ) disorder, confirmed by:
  • Radiographic evidence (e.g., cartilage thinning, joint space narrowing)
  • Symptoms such as jaw pain, restricted jaw movement, or muscle tension
  • Ability to provide written informed consent
  • No recent trauma to the TMJ or oral structures

排除标准

  • Diagnosed rheumatoid arthritis or other autoimmune joint conditions
  • Serious cardiovascular, neurological, or systemic disorders
  • Pregnant women
  • Patients with contraindications for orthodontic procedures or occlusal splint use
  • History of TMJ surgery
  • Uncontrolled bruxism or other parafunctional habits that require alternative treatment strategies

结局指标

主要结局

Change in TMJ Pain Intensity (VAS Score)

时间窗: Baseline, 3 months, and 6 months

Assessment of temporomandibular joint pain using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). This outcome evaluates the effectiveness of occlusal treatment in reducing TMJ-related pain.

Change in Jaw Function (Jaw Function Limitation Scale - JFLS)

时间窗: Baseline, 3 months, and 6 months

Measurement of jaw functionality using the JFLS, a patient-reported scale ranging from 0 (no limitation) to 20 (severe limitation). This assesses improvements in jaw movement and function following different interventions.

Radiographic Changes in TMJ Structure

时间窗: Baseline, 3 months, and 6 months

Evaluation of TMJ degeneration using radiographic imaging (X-ray and MRI), including assessment of joint space narrowing, cartilage thinning, and subchondral bone changes. Quantitative imaging will compare structural changes across groups.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sunil Kumar Vaddamanu

Assistant Professor

King Khalid University

研究点 (1)

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