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Completed

NCT Number: NCT06774196

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Khalid University

Abhā, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral Therapy Group

Behavioral

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

Standard Care Group

Procedure

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

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

  4. 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.

Sponsors and collaborators

Lead sponsor

King Khalid University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 14, 2025
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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