An interventional study of Occlusal Splint and Bite Correction Therapy and Conventional TMJ Therapy in Degenerative Joint Disease and TMD, sponsored by King Khalid University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-07.
Sponsored by King Khalid University · Not applicable, Interventional, and Treatment
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.
386 studies on the registry are indexed under Joint Diseases; 64 are open to participants now.
This study's enrollment of 150 is above the median of 102 across 251 interventional studies indexed under Joint Diseases.
Browse Joint Diseases studies →King Khalid University is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
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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
No recent trauma to the TMJ or oral structures
Exclusion Criteria:
Diagnosed rheumatoid arthritis or other joint conditions
Serious cardiovascular, neurological, or systemic disorders
Pregnant women
Patients with for orthodontic procedures or occlusal splint use
History of TMJ surgery
Uncontrolled bruxism or other parafunctional habits that require alternative treatment strategies
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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 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.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 3 months, and 6 months
Plan to share: No — 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.
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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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King Khalid University