Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06774196
Enrollment
120
Registered
2025-01-14
Start date
2025-03-05
Completion date
2025-03-05
Last updated
2025-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders, Chronic Pain, Anxiety Disorders

Keywords

Temporomandibular Disorders, Temporomandibular Joint, Cognitive Behavioral Therapy

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.

Interventions

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

BEHAVIORALBehavioral Therapy Group

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

Sponsors

King Khalid University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain IntensityBaseline, 8 weeks post-treatment, and 6-month follow-upAssesses changes in self-reported pain levels with scores ranging from 0 (no pain) to 10 (worst pain)levels (0 = no pain, 10 = worst pain)
Psychological Distress (Anxiety)Baseline, 8 weeks post-treatment, and 6-month follow-upMeasures depression levels with a score based on the frequency and severity of symptoms.
Psychological Distress (Depression)Baseline, 8 weeks post-treatment, and 6-month follow-upMeasures depression levels with a score based on the frequency and severity of symptoms.

Secondary

MeasureTime frameDescription
Maximum Mouth OpeningBaseline, 8 weeks post-treatment, and 6-month follow-upMeasures the maximum distance (in millimeters) between the upper and lower front teeth during maximum voluntary opening.
Long-Term Symptom Relief6-month follow-upSustained improvement in pain, jaw function, and psychological distress over time, assessed using VAS, GAD-7, PHQ-9, and TDI scores.
Jaw Range of MotionBaseline, 8 weeks post-treatment, and 6-month follow-upAssesses the range of motion of the jaw through physical examination, measuring angular movement in degrees.
Pain-Related DisabilityBaseline, 8 weeks post-treatment, and 6-month follow-upAssessed using the TMD Pain Disability Index (TDI) to evaluate the impact of pain on daily activities and quality of life

Countries

Saudi Arabia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026