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

NCT ID: NCT06948682

Last Updated: 2025-05-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2025-04-12

Brief Summary

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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.

Detailed Description

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Conditions

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Degenerative Joint Disease TMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

Occlusal Splint and Bite Correction Therapy

Intervention Type 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.

Routine TMJ Care (Medication Only)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Conventional TMJ Therapy

Intervention Type 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.

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.

Group Type NO_INTERVENTION

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.

Intervention Type DEVICE

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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King Khalid University

OTHER

Sponsor Role lead

Responsible Party

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Sunil Kumar Vaddamanu

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Khalid University

Abhā, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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ECC#2024-08

Identifier Type: -

Identifier Source: org_study_id

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