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

K

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)

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

Trial contacts and locations

1

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Central trial contact

Sunil Kumar Vaddamanu, MDS

Data sourced from clinicaltrials.gov

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