Exploring the Relationship Between Occlusion and Degenerative TMJ Disorders: A Comparative Clinical Study
NCT ID: NCT06948682
Last Updated: 2025-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
150 participants
INTERVENTIONAL
2025-01-10
2025-04-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
Yes
Sponsors
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King Khalid University
OTHER
Responsible Party
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Sunil Kumar Vaddamanu
Assistant Professor
Locations
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King Khalid University
Abhā, , Saudi Arabia
Countries
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Other Identifiers
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ECC#2024-08
Identifier Type: -
Identifier Source: org_study_id
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