Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation

Not Applicable

• Conditions: Temporomandibular Joint

• Registration Number: NCT06811415
• Lead Sponsor: Tanta University

Brief Summary

This study was planned to evaluate the accuracy of virtual surgical planning and three-dimensional (3D) printed templates in reconstruction of temporomandibular joint (TMJ) with costochondral graft.

Detailed Description

Eight patients (15-45) years diagnosed with TMJ deformities were included. A composite skull model was obtained with data from computed tomography. A virtual surgical simulation was performed using Dolphin Imaging 11.7 Premium. Then, the virtual plan was transferred to the operative field using 3D (CAD-CAM) printed surgical template. These templates were designed by 3D printing using data from the virtual surgical simulation for optimum selection of the rib graft, accurate tailoring of chondral and costal graft and as an osteotomy guide.

The preoperative measurement including mouth opening, facial asymmetry and differences between the actual mandibular position and the virtual plan were analyzed

Study Timeline

• Study Start: 2024-08-10
• Primary Completion: 2024-10-10
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-01-31
• Study First Posted: 2025-02-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Study Completion: 2025-05-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• TMJ deformity due to osteoarthrosis, ankylosis, injury, and pathology
• medicaly free patients

Exclusion Criteria

• bilateral TMJ deformity
• patients medically compromised

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
visual analogue scale	2 weeks	0 representing no pain and 10 representing the highest level of pain
inflammation score scale	1 month	0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

Secondary Outcome Measures

Name	Time	Method
mouth opening	6 months	normal ranged from 33 mm to 38 mm

Trial Locations

Locations (1)

Egypt; 🇪🇬 Tanta, Egypt