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

April 15, 2025 updated by: Sunil Kumar Vaddamanu, King Khalid University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioral Therapy Group
Participants receiving behavioral therapy (Cognitive Behavioral Therapy, relaxation techniques, and biofeedback).
Behavioral: Behavioral Therapy Group
Includes Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback.
Active Comparator: Standard Care Group
Participants will receive standard care, consisting of pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy.
Procedure: Standard Care Group
Includes pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity
Time Frame: 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)
Baseline, 8 weeks post-treatment, and 6-month follow-up
Psychological Distress (Anxiety)
Time Frame: Baseline, 8 weeks post-treatment, and 6-month follow-up
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)
Time Frame: Baseline, 8 weeks post-treatment, and 6-month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Mouth Opening
Time Frame: 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.
Baseline, 8 weeks post-treatment, and 6-month follow-up
Jaw Range of Motion
Time Frame: 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.
Baseline, 8 weeks post-treatment, and 6-month follow-up
Pain-Related Disability
Time Frame: 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
Baseline, 8 weeks post-treatment, and 6-month follow-up
Long-Term Symptom Relief
Time Frame: 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.
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Khalid University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2025

Primary Completion (Actual)

March 5, 2025

Study Completion (Actual)

March 5, 2025

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 8, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

April 18, 2025

Last Update Submitted That Met QC Criteria

April 15, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECM#2024-3196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual Participant Data (IPD) from this study will not be shared with other researchers. This decision is based on the need to protect participant privacy and confidentiality, as well as the sensitive nature of the data collected, including psychological and health-related information. Although the study results will be shared in aggregated and anonymized formats through publications and presentations, no raw or identifiable participant data will be disclosed to external parties. This approach ensures compliance with ethical guidelines and data protection regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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