Clinical trial NCT06948682: Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study
Official title: Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Degenerative Joint Disease
TMD
Keywords: TMD
Occlusal therapy
Degenerative joint disease
Pain management
Biomechanical stress
Lead sponsor: King Khalid University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study involves three separate groups of participants receiving different interventions:

Group 1: Occlusal treatment

Group 2: Conventional therapy

Group 3: Standard management (control)

Each participant is assigned to one group only and continues in that group throughout the study. This design is characteristic of a parallel assignment, where participants in different groups receive different interventions simultaneously.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in TMJ Pain Intensity (VAS Score)
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Jaw Function (Jaw Function Limitation Scale - JFLS)
timeFrame: Baseline, 3 months, and 6 months
measure: Radiographic Changes in TMJ Structure
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Abha
country: Saudi Arabia
facility: King Khalid University
Study officials:
References: