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

NCT06948682 | Completed DMC

• 1 other identifier: ECC#2024-08
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Joint Disease; TMD

Keywords

TMD; Occlusal therapy; Degenerative joint disease; Pain management; Biomechanical stress

Outcome Measures

Primary Outcomes (3)

• Change in TMJ Pain Intensity (VAS Score)

  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.

  Baseline, 3 months, and 6 months

• Change in Jaw Function (Jaw Function Limitation Scale - JFLS)

  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.

  Baseline, 3 months, and 6 months

• Radiographic Changes in TMJ Structure

  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.

  Baseline, 3 months, and 6 months

Study Arms (3)

Occlusal Treatment Group

EXPERIMENTAL

Participants in this group will receive occlusal treatment, including bite correction procedures and the use of occlusal splints, for a duration of 6 months. Monthly follow-ups will be conducted to monitor progress and make adjustments as needed.

Device: Occlusal Splint and Bite Correction Therapy; Other: Routine TMJ Care (Medication Only)

Conventional Treatment Group

ACTIVE COMPARATOR

Participants in this group will receive conventional TMJ therapy, including physical therapy, lifestyle modification counseling, and anti-inflammatory medications. Treatment is administered over 6 months with monthly clinical evaluations.

Other: Conventional TMJ Therapy

Standard Care Group

NO INTERVENTION

Participants in this group will receive routine TMJ care involving only analgesic or anti-inflammatory medication as needed. No occlusal or physical therapy will be provided. Follow-up is conducted monthly for 6 months to assess standard care outcomes.

Interventions

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.

Occlusal Treatment Group

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.

Conventional Treatment Group

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.

Occlusal Treatment Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• King Khalid University: lead

Study Sites (1)

King Khalid University

Abhā, Saudi Arabia

Location

MeSH Terms

Conditions

Joint Diseases; Agnosia

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 29, 2025
• Study Start: January 10, 2025
• Primary Completion: April 12, 2025
• Study Completion: April 12, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)