Clinical trial NCT06774196: Integrating Behavioral Therapy in the Management of Temporomandibular Disorders: A Comprehensive Evaluation Using DC/TMD Axis II Criteria
Official title: Integrating Behavioral Therapy in the Management of Temporomandibular Disorders: A Comprehensive Evaluation Using DC/TMD Axis II Criteria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporomandibular Joint Disorders
Chronic Pain
Anxiety Disorders
Keywords: Temporomandibular Disorders
Temporomandibular Joint
Cognitive Behavioral Therapy
Lead sponsor: King Khalid University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pain Intensity
timeFrame: Baseline, 8 weeks post-treatment, and 6-month follow-up
measure: Psychological Distress (Anxiety)
timeFrame: Baseline, 8 weeks post-treatment, and 6-month follow-up
measure: Psychological Distress (Depression)
timeFrame: Baseline, 8 weeks post-treatment, and 6-month follow-up
Secondary outcomes:
measure: Maximum Mouth Opening
timeFrame: Baseline, 8 weeks post-treatment, and 6-month follow-up
measure: Jaw Range of Motion
timeFrame: Baseline, 8 weeks post-treatment, and 6-month follow-up
measure: Pain-Related Disability
timeFrame: Baseline, 8 weeks post-treatment, and 6-month follow-up
measure: Long-Term Symptom Relief
timeFrame: 6-month follow-up
Other outcomes:
Locations:
city: Abha
country: Saudi Arabia
facility: King Khalid University
Study officials:
References: