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

May 4, 2025 updated by: Sunil Kumar Vaddamanu, King Khalid University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Occlusal Treatment Group
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
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.
Other: Routine TMJ Care (Medication Only)
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.
Active Comparator: Conventional Treatment Group
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
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.
No Intervention: Standard Care Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 3 months, and 6 months
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.
Baseline, 3 months, and 6 months
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.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Khalid University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Actual)

April 12, 2025

Study Completion (Actual)

April 12, 2025

Study Registration Dates

First Submitted

April 15, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

April 29, 2025

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECC#2024-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The individual participant data (IPD) will not be shared due to confidentiality concerns and institutional policies restricting the distribution of patient-level data. While aggregated data may be published in scientific reports, raw individual-level data will remain confidential to protect participant privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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