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Completed

NCT Number: NCT06948682

Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study

The study "Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study" investigated the efficacy of occlusal therapy in managing degenerative temporomandibular joint (TMJ) disorders. Conducted over 6 months with 150 patients, it compared three groups: occlusal therapy (Group 1), conventional treatment (Group 2), and routine care (Group 3). Group 1 showed significant improvements, including a 65% pain reduction, 51% better jaw function, slower joint degeneration, 64% less muscle tension, 24% improved jaw mobility, and enhanced quality of life, outperforming the other groups. The findings support occlusal therapy's role in multidisciplinary TMJ management, though long-term studies are needed.

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Key information

Conditions

Degenerative Joint Disease Agnosia Joint Diseases Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms TMD

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 to 65 years

Clinical diagnosis of moderate to severe degenerative temporomandibular joint (TMJ) disorder, confirmed by:

Radiographic evidence (e.g., cartilage thinning, joint space narrowing)

Symptoms such as jaw pain, restricted jaw movement, or muscle tension

Ability to provide written informed consent

No recent trauma to the TMJ or oral structures

Exclusion criteria

Diagnosed rheumatoid arthritis or other autoimmune joint conditions

Serious cardiovascular, neurological, or systemic disorders

Pregnant women

Patients with contraindications for orthodontic procedures or occlusal splint use

History of TMJ surgery

Uncontrolled bruxism or other parafunctional habits that require alternative treatment strategies

Treatment and study plan

Occlusal Splint and Bite Correction Therapy

Device

Participants receive individualized occlusal therapy involving occlusal splint use and bite correction (if needed). The treatment is applied continuously over a 6-month period. Monthly follow-up visits are conducted to monitor symptoms, adjust therapy, and evaluate radiographic changes in the TMJ.

Conventional TMJ Therapy

Other

Participants undergo a 6-month conventional management program including pain medication (NSAIDs), physical therapy (jaw exercises, hot/cold therapy), and lifestyle guidance (diet modifications, stress reduction). Monthly clinical evaluations assess functional improvement and symptom reduction.

Routine TMJ Care (Medication Only)

Other

Participants receive standard pharmacological management for TMJ disorders (e.g., NSAIDs or analgesics) with no occlusal or physical therapy interventions. Follow-up assessments occur monthly for 6 months to monitor symptom progression and response to minimal intervention.

Primary outcomes

  1. Change in TMJ Pain Intensity (VAS Score)

    Time frame: Baseline, 3 months, and 6 months

    Assessment of temporomandibular joint pain using the Visual Analog Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). This outcome evaluates the effectiveness of occlusal treatment in reducing TMJ-related pain.

  2. Change in Jaw Function (Jaw Function Limitation Scale - JFLS)

    Time frame: Baseline, 3 months, and 6 months

    Measurement of jaw functionality using the JFLS, a patient-reported scale ranging from 0 (no limitation) to 20 (severe limitation). This assesses improvements in jaw movement and function following different interventions.

  3. Radiographic Changes in TMJ Structure

    Time frame: Baseline, 3 months, and 6 months

    Evaluation of TMJ degeneration using radiographic imaging (X-ray and MRI), including assessment of joint space narrowing, cartilage thinning, and subchondral bone changes. Quantitative imaging will compare structural changes across groups.

Sponsors and collaborators

Lead sponsor

King Khalid University

Other

Registry information

Acronym: TMJ

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 29, 2025
Registry last updated
May 7, 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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