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

Launched by FUJIAN MEDICAL UNIVERSITY · Jul 27, 2025

Keywords

ClinConnect Summary

This study tests whether three different ways of setting the jaw position for a repositioning mouth splint affect how well the splint helps people with a specific jaw problem called temporomandibular joint (TMJ) disk displacement without reduction. Participants are randomly assigned to one of three groups: (1) jaw position determined by a mechanical articulator, (2) AI-assisted virtual articulator, or (3) AI-assisted virtual patient. All participants use the repositioning splint for 3–6 months, with clinic visits about every 3 weeks to check progress and do tests. The trial uses triple masking, meaning participants, care providers, and those measuring outcomes don’t know which method was used.

Who can join: people aged 13–50 with permanent teeth who meet the study’s diagnostic criteria and have MRI-confirmed unilateral irreducible disc displacement in one TMJ. Exclusions include serious systemic or psychiatric illness, pain-only disorders without joint pathology, jaw tumors or prior TMJ treatment, and other issues. The study is run by Fujian Medical University in China. It’s designed to compare three active approaches rather than a placebo, and its primary outcomes look at the position of the jaw joint after treatment using 3D imaging, while secondary outcomes assess jaw function and muscle tenderness over 3–6 months. About 45 participants are planned, with start in July 2025 and expected completion in August 2026; results are not yet available.

Gender

ALL

Eligibility criteria

• 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.