Degenerative Joint DiseaseTMJNCT06948682
Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study
A study testing Occlusal Splint and Bite Correction Therapy, Conventional TMJ Therapy and Routine TMJ Care (Medication Only) in people with Degenerative Joint Disease and TMD, run by King Khalid University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Joint Disease, TMD
- What is being tested?
- Occlusal Splint and Bite Correction Therapy, Conventional TMJ Therapy and Routine TMJ Care (Medication Only)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 10 Jan 2025to 12 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Degenerative Joint Disease, TMD
- Being tested
- Occlusal Splint and Bite Correction Therapy, Conventional TMJ Therapy, Routine TMJ Care (Medication Only)
- Keywords
- TMD, Occlusal therapy, Degenerative joint disease, Pain management, Biomechanical stress
- Medical subject headings
- Joint Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Occlusal Splint and Bite Correction TherapyDevice
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 TherapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start10 Jan 2025
- Primary completion12 Apr 2025
- Study completion12 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Kumar Vaddamanu, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948682
- Sponsor's protocol ID
- ECC#2024-08
- Acronym
- TMJ
- Status last verified
- May 2025
- First submitted
- 15 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT06948682
- Acronym / sponsor ID
- TMJ / ECC#2024-08
- Conditions
- Degenerative Joint Disease, TMD
- Keywords
- TMD, Occlusal therapy, Degenerative joint disease, Pain management, Biomechanical stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 12 Apr 2025 (actual)
- Study completion
- 12 Apr 2025 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Occlusal Treatment Group | Experimental | Device: Occlusal Splint and Bite Correction Therapy, Other: Routine TMJ Care (Medication Only)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. |
| Conventional Treatment Group | Active comparator | Other: Conventional TMJ TherapyParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Occlusal Splint and Bite Correction TherapyParticipants 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. | Device | Occlusal Treatment Group |
| Conventional TMJ TherapyParticipants 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. | Other | Conventional Treatment Group |
| 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. | Other | Occlusal Treatment Group |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Occlusal Splint and Bite Correction Therapy, Conventional TMJ Therapy and Routine TMJ Care (Medication Only) in people with Degenerative Joint Disease and TMD, run by King Khalid University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in TMJ Pain Intensity (VAS Score) (time frame: Baseline, 3 months, and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.