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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Repositioning splint therapy with jaw position determined by mechanical articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator, Repositioning splint therapy with jaw position determined by ai-assisted virtual patient.
- Who it may be relevant to
- Registry conditions: Temporomandibular Disorder (TMD). Basic parameters: 13 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Procedure Repositioning splint therapy with jaw position determined by mechanical articulator
The therapeutic jaw position will be determined by the following steps: 1. Pre-treatment Jaw Position Recording Participants were seated upright with relaxed posture, eyes facing forward, and the Frankfort plane parallel to the floor. Intercuspal position (ICP) was recorded using silicone registration material. Edge-to-edge position of central incisors was recorded for protrusive position. Left/right lateral positions were recorded with opposing canines aligned. 2. Transfer of Jaw Positions Fol - Procedure Repositioning splint therapy with jaw position determined by ai-assisted virtual articulator
The jaw position was determined by the following steps: 1. AI-Based Segmentation and Reconstruction of Jaw Models CBCT DICOM data was imported into an ai-based craniomaxillofacial bone segmentation system to reconstruct 3D models of the jaws and dentition. The mandibular/maxillary bone models and dental arches were exported as .ply files. These .ply files were then imported into Exocad software. 2. Virtual Transfer of Jaw Positions Bilateral AI-segmented medial pole points of the condyles and t - Procedure Repositioning splint therapy with jaw position determined by ai-assisted virtual patient
The jaw position was determined by the following steps: 1. AI-Based Segmentation and Reconstruction of Virtual Patients: CBCT DICOM data was imported into an ai-based craniomaxillofacial bone segmentation system to reconstruct 3D models of the jaws and dentition. The trajectory of mandibular movement was recorded by an electronic facebow. 2. Virtual Transfer of Jaw Positions Bilateral AI-segmented medial pole points of the condyles and the right infraorbital point were annotated in cross-se
Primary outcome measures
- Condylar position as assessed by CBCT measurements [Time frame: 3-6 months]
- Condylar repositioning rate as assessed by CBCT measurements [Time frame: 3-6 months]
Secondary outcome measures (3)
- Fricton index as assessed by comprehensive physical examination to participants [Time frame: 3-6 months]
- Dysfunction index as assessed by by comprehensive physical examination to participants [Time frame: 3-6 months]
- Palpation index as assessed by by comprehensive physical examination to participants [Time frame: 3-6 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fujian Medical University — Fuzhou
Identifiers
NCT: NCT07090772 · 2025ECSS057