Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 1:07 AM
Study NCT ID:
NCT07345104
Status:
COMPLETED
Last Update Posted:
2026-02-11
First Post:
2025-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement
Sponsor:
Fujian Medical University
Organization:
Study Overview
Official Title:
Accuracy of Digital Mandibular Repositioning in Occlusal Reconstruction for Patients With Disc Displacement: A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
Detailed Description This study evaluates four different methods for mandibular repositioning in patients with bilateral reducible temporomandibular joint (TMJ) disc displacement requiring occlusal reconstruction.
Methods of Mandibular Repositioning:
1. Intraoral Direct Positioning Group: The therapeutic jaw position is determined clinically using the clicking elimination method, where patients open wide until clicking occurs, then gradually retract the mandible while performing opening-closing movements to find the minimal protrusion position without clicking.
2. Articulator Positioning Group: Uses mechanical facebow transfer and semi-adjustable articulator (Artex CR) with condylar guidance parameters obtained from protrusive and lateral excursion records. The therapeutic position is determined by analyzing CBCT joint space measurements and MRI disc displacement data.
3. Digital Anatomical Positioning Group: Combines intraoral scanning data with CBCT-reconstructed 3D jaw models. The therapeutic position is determined by referencing MRI disc reduction phase, optimal joint space ratios, and anatomical landmarks using CAD software (Exocad).
4. Digital Jaw Motion Tracking Group: Integrates 3D jaw models with electronic jaw tracking data (Zebris). The therapeutic position is determined by analyzing condylar movement trajectories (identifying the "figure-8" pattern crossover points indicating disc displacement) combined with dynamic MRI and optimal joint space parameters.
Treatment Protocol: All groups receive digitally designed and manufactured repositioning splints. Patients wear splints 24 hours daily (except during meals) for 3 months, with follow-up adjustments at 2 weeks, 1 month, 2 months, and 3 months.
Imaging Protocol:
* CBCT (I-CAT FLX): 120 kV, 5 mA, 0.2 mm resolution
* MRI (GE Discovery MR750w 3.0T): Bilateral TMJ surface coils, oblique sagittal and coronal views in closed-mouth position, oblique sagittal in maximum opening
Assessment Methods:
* Joint space measurements using Ikeda's method on registered pre- and post-treatment CBCT images
* Condyle position analysis using Gelb 4/7 position criteria
* Disc-condyle angle measurement on MRI (\>15° defined as disc displacement)
Methods of Mandibular Repositioning:
1. Intraoral Direct Positioning Group: The therapeutic jaw position is determined clinically using the clicking elimination method, where patients open wide until clicking occurs, then gradually retract the mandible while performing opening-closing movements to find the minimal protrusion position without clicking.
2. Articulator Positioning Group: Uses mechanical facebow transfer and semi-adjustable articulator (Artex CR) with condylar guidance parameters obtained from protrusive and lateral excursion records. The therapeutic position is determined by analyzing CBCT joint space measurements and MRI disc displacement data.
3. Digital Anatomical Positioning Group: Combines intraoral scanning data with CBCT-reconstructed 3D jaw models. The therapeutic position is determined by referencing MRI disc reduction phase, optimal joint space ratios, and anatomical landmarks using CAD software (Exocad).
4. Digital Jaw Motion Tracking Group: Integrates 3D jaw models with electronic jaw tracking data (Zebris). The therapeutic position is determined by analyzing condylar movement trajectories (identifying the "figure-8" pattern crossover points indicating disc displacement) combined with dynamic MRI and optimal joint space parameters.
Treatment Protocol: All groups receive digitally designed and manufactured repositioning splints. Patients wear splints 24 hours daily (except during meals) for 3 months, with follow-up adjustments at 2 weeks, 1 month, 2 months, and 3 months.
Imaging Protocol:
* CBCT (I-CAT FLX): 120 kV, 5 mA, 0.2 mm resolution
* MRI (GE Discovery MR750w 3.0T): Bilateral TMJ surface coils, oblique sagittal and coronal views in closed-mouth position, oblique sagittal in maximum opening
Assessment Methods:
* Joint space measurements using Ikeda's method on registered pre- and post-treatment CBCT images
* Condyle position analysis using Gelb 4/7 position criteria
* Disc-condyle angle measurement on MRI (\>15° defined as disc displacement)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: