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

King Khalid University

Status: Completed

Conditions: Temporomandibular Joint Disorders; Chronic Pain; Anxiety Disorders

Treatments: Behavioral: Behavioral Therapy Group; Procedure: Standard Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT06774196

ECM#2024-3196

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Behavioral Therapy Group

Experimental group

Description:

Participants receiving behavioral therapy (Cognitive Behavioral Therapy, relaxation techniques, and biofeedback).

Treatment:

Behavioral: Behavioral Therapy Group

Standard Care Group

Active Comparator group

Description:

Participants will receive standard care, consisting of pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy.

Treatment:

Procedure: Standard Care Group