Integrating Behavioral Therapy in the Management of Temporomandibular Disorders: A Comprehensive Evaluation Using DC/TMD Axis II Criteria

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders; Anxiety Disorders; Chronic Pain

• Registration Number: NCT06774196
• Lead Sponsor: King Khalid University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-01-14
• Study Start: 2025-03-05
• Primary Completion: 2025-03-05
• Study Completion: 2025-03-05
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Intensity	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)	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)	Baseline, 8 weeks post-treatment, and 6-month follow-up	Measures depression levels with a score based on the frequency and severity of symptoms.

Secondary Outcome Measures

Name	Time	Method
Maximum Mouth Opening	Baseline, 8 weeks post-treatment, and 6-month follow-up	Measures the maximum distance (in millimeters) between the upper and lower front teeth during maximum voluntary opening.
Jaw Range of Motion	Baseline, 8 weeks post-treatment, and 6-month follow-up	Assesses the range of motion of the jaw through physical examination, measuring angular movement in degrees.
Pain-Related Disability	Baseline, 8 weeks post-treatment, and 6-month follow-up	Assessed using the TMD Pain Disability Index (TDI) to evaluate the impact of pain on daily activities and quality of life
Long-Term Symptom Relief	6-month follow-up	Sustained improvement in pain, jaw function, and psychological distress over time, assessed using VAS, GAD-7, PHQ-9, and TDI scores.

Trial Locations

Locations (1)

King Khalid University; 🇸🇦 Abha, Saudi Arabia