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

NCT06774196 | Completed DMC

• 1 other identifier: ECM#2024-3196
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Temporomandibular Disorders; Temporomandibular Joint; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (3)

• Pain Intensity

  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)

  Baseline, 8 weeks post-treatment, and 6-month follow-up

• Psychological Distress (Anxiety)

  Measures depression levels with a score based on the frequency and severity of symptoms.

  Baseline, 8 weeks post-treatment, and 6-month follow-up

• Psychological Distress (Depression)

  Measures depression levels with a score based on the frequency and severity of symptoms.

  Baseline, 8 weeks post-treatment, and 6-month follow-up

Secondary Outcomes (4)

• 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

Study Arms (2)

Behavioral Therapy Group

EXPERIMENTAL

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

Behavioral: Behavioral Therapy Group

Standard Care Group

ACTIVE COMPARATOR

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

Procedure: Standard Care Group

Interventions

Behavioral Therapy Group BEHAVIORAL

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

Behavioral Therapy Group

Standard Care Group PROCEDURE

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

Standard Care Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Khalid University: lead

Study Sites (1)

King Khalid University

Abhā, Saudi Arabia

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Chronic Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 14, 2025
• Study Start: March 5, 2025
• Primary Completion: March 5, 2025
• Study Completion: March 5, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)