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临床试验/NCT06758479
NCT06758479已完成不适用

Correlations Between Disc Position and the Key Clinical Outcomes in TMD Patients: Cross-sectional Study

King Khalid University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年12月26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
100
试验地点
1
主要终点
Pain Severity

研究概览

简要总结

This study aims to explore the relationship between the position of the temporomandibular joint (TMJ) disc and key clinical outcomes in patients with temporomandibular disorders (TMD). TMD is a condition that can cause pain, difficulty in jaw movement, and reduced quality of life. The research examines how disc displacement, as seen on MRI scans, correlates with pain levels, jaw function, and overall well-being. By better understanding these connections, the study seeks to provide insights that could improve the diagnosis and management of TMD, enhancing patient care and outcomes. This observational study involves non-invasive clinical and imaging assessments of TMD patients.

详细描述

This observational, cross-sectional study investigates the correlation between temporomandibular joint (TMJ) disc position and clinical outcomes in patients diagnosed with temporomandibular disorders (TMD). TMD encompasses conditions causing pain, jaw dysfunction, and diminished quality of life. The study evaluates disc displacement using magnetic resonance imaging (MRI) and measures clinical outcomes such as pain severity (Visual Analog Scale), functional limitations (Helkimo Index), and quality of life (Oral Health Impact Profile-14).

Participants include 100 individuals aged 18-65 with clinically confirmed TMD. Data collection involves clinical evaluations and MRI imaging to classify disc displacement into categories such as normal, with reduction, and without reduction. Statistical analyses, including correlation and regression, identify relationships between disc position and outcomes while accounting for confounding factors.

The findings aim to improve understanding of the pathophysiology of TMD and guide diagnostic and therapeutic strategies for better patient outcomes. The study adheres to ethical guidelines, ensuring informed consent and patient confidentiality.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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 between 18 and 65 years.
  • Diagnosed with temporomandibular disorders (TMD) based on clinical examination and imaging (MRI).
  • Presence of at least one of the following symptoms:
  • Restricted jaw movement
  • Clicking sounds in the temporomandibular joint (TMJ)
  • No history of recent jaw or facial trauma.
  • No systemic diseases affecting the TMJ or musculoskeletal system (e.g., rheumatoid arthritis).
  • Able to provide informed consent.

排除标准

  • History of major jaw or facial trauma within the last six months.
  • Systemic conditions that might affect TMJ function, such as autoimmune diseases or bone disorders.
  • Previous TMJ surgery or other major interventions.
  • Pregnant or lactating women.
  • Inability to undergo MRI due to contraindications (e.g., metal implants, pacemakers).
  • Severe malocclusion or other dental/medical conditions interfering with TMD diagnosis.

结局指标

主要结局

Pain Severity

时间窗: Measured at the time of enrollment.

Pain severity will be assessed using the Visual Analog Scale (VAS), considering the patient's average pain experienced over the past month.

次要结局

  • Functional Limitations(Measured at the time of enrollment)

研究者

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

Sunil Kumar Vaddamanu

Dr

King Khalid University

研究点 (1)

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