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

Fujian Medical University

Status: Invitation-only

Conditions: Temporomandibular Disorder (TMD)

Treatments: Procedure: Repositioning splint therapy with jaw position determined by ai-assisted virtual patient; Procedure: Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator; Procedure: Repositioning splint therapy with jaw position determined by mechanical articulator

Study type: Interventional

Funder types: Other

Identifiers

NCT07090772

2025ECSS057

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 13 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

receive repositioning splint therapy with jaw position determined by mechanical articulator

Experimental group

Description:

Participants will receive repositioning splint therapy with jaw position determined by mechanical articulator method for 3-6 months.

Treatment:

Procedure: Repositioning splint therapy with jaw position determined by mechanical articulator

receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator

Experimental group

Description:

Participants will receive repositioning splint therapy with jaw position determined by ai-assisted virtual articulator.

Treatment:

Procedure: Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator

receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient

Experimental group

Description:

Participants will receive repositioning splint therapy with jaw position determined by ai-assisted virtual patient

Treatment:

Procedure: Repositioning splint therapy with jaw position determined by ai-assisted virtual patient