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

NCT ID: NCT06774196

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-05
• Study Completion Date: 2025-03-05

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.

Conditions

Temporomandibular Joint Disorders; Chronic Pain; Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Behavioral Therapy Group

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

Group Type: EXPERIMENTAL

Behavioral Therapy Group

Intervention Type: BEHAVIORAL

Includes Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback.

Standard Care Group

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

Group Type: ACTIVE_COMPARATOR

Standard Care Group

Intervention Type: PROCEDURE

Includes pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy interventions

Interventions

Behavioral Therapy Group

Includes Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback.

Intervention Type: BEHAVIORAL

Standard Care Group

Includes pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy interventions

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Khalid University

OTHER

Sponsor Role: lead

Responsible Party

Sunil Kumar Vaddamanu

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

King Khalid University

Abhā, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

ECM#2024-3196

Identifier Type: -

Identifier Source: org_study_id