The Effectiveness of Different Therapeutic Jaw Position Determining Methods in Repositioning Splint Therapy for Temporomandibular Joint Disk Displacement Without Reduction：A Randomized Controlled Clinical Trial

Not Applicable

• Conditions: Temporomandibular Disorder (TMD)

• Registration Number: NCT07090772
• Lead Sponsor: Fujian Medical University

Brief Summary

The goal of this clinical trial is to learn if different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction. The main questions it aims to answer are:

Does different therapeutic jaw position determining methods influence the efficacy of repositioning splint therapy for temporomandibular joint disk displacement without reduction? Researchers will compare the efficacy of repositioning splint therapy made with different therapeutic jaw position determining methods for temporomandibular joint disk displacement without reduction.

Participants will:

Take repositioning splint made with different therapeutic jaw position determining methods every day for 3-6 months.

Visit the clinic once every 3 weeks for checkups and tests.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study Start: 2025-07-20
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-27
• Last Update Submitted: 2025-07-27
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Primary Completion: 2026-08-20
• Study Completion: 2026-08-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Aged 13-50 years, with permanent dentition, possessing full autonomy in behavior and expression;
• Meeting the 2014 Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) diagnostic standards for irreducible temporomandibular joint disc displacement;
• MRI-confirmed unilateral irreducible disc displacement: At maximum intercuspation: Posterior band of disc located anterior to the 11:30 position, intermediate zone anterior to condyle; At maximum mouth opening: Intermediate zone remains anterior to condyle.

Exclusion Criteria

• Systemic diseases, psychiatric disorders, or impaired consciousness;
• Pain-only disorders without articular pathology signs;
• Mandibular hypoplasia, TMJ tumors, or prior TMJ trauma;
• History of definitive TMJ disorder treatment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Condylar position as assessed by CBCT measurements	3-6 months	Condylar position of the three groups will be assessed after each treatment based on the measurements of sagittal joint spaces (anterior/superior/posterior) on CBCT's cross-sectional views.
Condylar repositioning rate as assessed by CBCT measurements	3-6 months	Using Mimics software, post-treatment condylar positions were analyzed and measured. The proportions of affected-side condyles reposition to the Gelb 4/7 position were compared across the three therapeutic jaw position determination methods.

Secondary Outcome Measures

Name	Time	Method
Fricton index as assessed by comprehensive physical examination to participants	3-6 months	Fricton index consists of dysfunction index and palpation index, which can quantify mandibular function and movement, palpation of muscles and other indicators, and is widely used to evaluate the clinical efficacy of temporomandibular disorders.
Dysfunction index as assessed by by comprehensive physical examination to participants	3-6 months	Dysfunction index refers to the comprehensive Index that reflect temporomandibular joint tenderness and functioning problems.
Palpation index as assessed by by comprehensive physical examination to participants	3-6 months	Palpation index refers to the comprehensive index that reflect muscle tenderness problems.

Trial Locations

Locations (1)

Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China