Clinical Trial

Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement

Completed
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Summary
This study evaluates a new, individualized treatment for adolescents with temporomandibular joint disorders (TMD) caused by bilateral, reducible disc displacement. Participants will undergo clinical and imaging examinations, including cone-beam CT (CBCT), MRI, and intraoral digital scanning to create three-dimensional models of the teeth and jaw. Based on these data, the study team will design and fabricate a personalized repositioning digital occlusal splint for each participant. Patients will be instructed on how to wear the splint and will return for regular follow-up visits to monitor symptoms and adjust the splint as needed. The study aims to improve pain, chewing function, and overall quality of life. All research-related imaging, digital scans, splint fabrication, and follow-up visits will be provided at no cost to participants. Possible risks include temporary discomfort or pressure when first wearing the splint, and the possibility that symptoms may not improve as expected. Participant safety, privacy, and data confidentiality will be strictly protected, and participants may withdraw from the study at any time without affecting their future medical care.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-06.
Trial Details
NCT Number NCT07345104
Lead Sponsor Fujian Medical University
Conditions Temporomandibular Joint Disc Displacement
Enrollment 48 participants
Start Date 2025-06-20
Primary Completion 2025-12-20 (estimated)
Study Completion 2025-12-20 (estimated)
Updated on ClinicalTrials.gov 2026-02-11