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

NCT07090772 | Enrolling By Invitation DMC

• 1 other identifier: 2025ECSS057
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder (TMD)

Outcome Measures

Primary Outcomes (2)

• Condylar position as assessed by CBCT measurements

  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.

  3-6 months

• Condylar repositioning rate as assessed by CBCT measurements

  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.

  3-6 months

Secondary Outcomes (3)

• Fricton index as assessed by comprehensive physical examination to participants

  3-6 months

• Dysfunction index as assessed by by comprehensive physical examination to participants

  3-6 months

• Palpation index as assessed by by comprehensive physical examination to participants

  3-6 months

Study Arms (3)

receive repositioning splint therapy with jaw position determined by mechanical articulator

EXPERIMENTAL

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

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

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

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

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

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

Interventions

Repositioning splint therapy with jaw position determined by mechanical articulator PROCEDURE

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 Following the manufacturer's protocol for the Artex CR mechanical facebow (Amann Girrbach, Austria) to transfer Participants' jaw positions. 3. Determination of Therapeutic Position The Glenoid fossa was divided into 7 grids in the oblique-sagittal plane using Gelb's method, identifying grid 4 (Gelb 4/7) as the target condylar position.Condylar displacement knobs were set per VTO analysis. Incisal pin height was increased to establish vertical dimension.

receive repositioning splint therapy with jaw position determined by mechanical articulator

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

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 the right infraorbital point were annotated in cross-sectional views.A virtual articulator was added and registered to the facebow's reference planes and hinge axis. (3)Determination of Therapeutic Position Sagittal joint spaces (anterior/superior/posterior) were measured on cross-sectional views. The composite mandibular model was repositioned to the target occlusion using the "Move Mesh" function based on: Optimal mean joint space measurements and physiological condylar position.

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

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

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-sectional views.A virtual articulator was added and registered to the facebow's reference planes and hinge axis. (3)Determination of Therapeutic Position Sagittal joint spaces (anterior/superior/posterior) were measured on cross-sectional views. The therapeutic position was determined based on: Optimal mean joint space measurements, physiological condylar position and optimal trajectory of mandibular movement.

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

Eligibility Criteria

• Age: 13 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Study Officials

• Hao Yu, PhD, MD

  Fujian Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director; Clinical Professor; dean of overseas education college; vice dean of school and hospital of stomatology

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: July 20, 2025
• Primary Completion (Estimated): August 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)