Integrating Behavioral Therapy in the Management of Temporomandibular Disorders: A Comprehensive Evaluation Using DC/TMD Axis II Criteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Pain Intensity
研究概览
简要总结
This study evaluates the efficacy of behavioral therapy, including Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback, in managing Temporomandibular Disorders (TMD). It aims to address both the physical and psychological aspects of TMD, focusing on pain reduction, improved jaw function, and alleviating psychological distress such as anxiety and depression. Participants are randomized into two groups: an intervention group receiving behavioral therapy and a control group receiving standard care. Outcomes will be assessed using validated tools to measure pain intensity, jaw function, and psychological well-being at baseline, post-treatment, and at a 6-month follow-up. This research seeks to establish the role of behavioral therapy as a key component in the comprehensive management of TMD.
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
- 是
入选标准
- •Adults aged 18-65 years.
- •Diagnosed with Temporomandibular Disorders (TMD) based on DC/TMD Axis I and Axis II criteria.
- •Presenting with symptoms such as jaw pain, limited jaw movement, or psychosocial distress (anxiety, depression).
- •Willing and able to provide informed consent.
- •Able to comply with the study protocol and attend all follow-up visits.
排除标准
- •Severe systemic diseases or other neurological conditions that could interfere with treatment or outcomes.
- •History of psychiatric disorders unrelated to TMD, such as schizophrenia or bipolar d disorder.
- •Pregnant or lactating women.
- •Use of medications or treatments within the past month that could influence study outcomes (e.g., corticosteroids, strong analgesics).
- •Individuals with severe dental or maxillofacial conditions requiring immediate surgical intervention.
- •Non-compliance with previous medical advice or treatment for TMD. Participants unable to understand or follow the study procedures due to language barriers or cognitive impairments.
结局指标
主要结局
Pain Intensity
时间窗: Baseline, 8 weeks post-treatment, and 6-month follow-up
Assesses changes in self-reported pain levels with scores ranging from 0 (no pain) to 10 (worst pain)levels (0 = no pain, 10 = worst pain)
Psychological Distress (Anxiety)
时间窗: Baseline, 8 weeks post-treatment, and 6-month follow-up
Measures depression levels with a score based on the frequency and severity of symptoms.
Psychological Distress (Depression)
时间窗: Baseline, 8 weeks post-treatment, and 6-month follow-up
Measures depression levels with a score based on the frequency and severity of symptoms.
次要结局
- Maximum Mouth Opening(Baseline, 8 weeks post-treatment, and 6-month follow-up)
- Jaw Range of Motion(Baseline, 8 weeks post-treatment, and 6-month follow-up)
- Pain-Related Disability(Baseline, 8 weeks post-treatment, and 6-month follow-up)
- Long-Term Symptom Relief(6-month follow-up)
研究者
Sunil Kumar Vaddamanu
Assistant Professor
King Khalid University