Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation

NCT06811415 | Completed

• 1 other identifier: #R-OS-10-24-3149
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint

Keywords

3D printed templates; computer-assisted surgical simulation; costochondral graft; temporomandibular joint

Outcome Measures

Primary Outcomes (2)

• visual analogue scale

  0 representing no pain and 10 representing the highest level of pain

  2 weeks

• inflammation score scale

  0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation

  1 month

Secondary Outcomes (1)

• mouth opening

  6 months

Study Arms (1)

virtual Tmj reconstruction with rib graft

OTHER

All patients were placed in preoperative occlusion in CASS. The planned rib was harvested in the standard manner through an inframammary incision. The length of the rib was equal to the prefabricated template as calculated in the cranial-maxillofacial 3D reconstruction, and comprised at most 5 mm of cartilage. The cartilage was trimmed and contoured to facilitate the setting of the cartilage side properly into the center of the TMJ fossa. A 4-hole titanium plate was fixed with four bicortical screws as previously planned

Procedure: virtual temporomandibular joint reconstruction with costochondral graft

Interventions

virtual temporomandibular joint reconstruction with costochondral graft PROCEDURE

All patients were placed in preoperative occlusion in CASS. The planned rib was harvested in the standard manner through an inframammary incision. The length of the rib was equal to the prefabricated template as calculated in the cranial-maxillofacial 3D reconstruction, and comprised at most 5 mm of cartilage. The cartilage was trimmed and contoured to facilitate the setting of the cartilage side properly into the center of the TMJ fossa. A 4-hole titanium plate was fixed with four bicortical screws as previously planned

virtual Tmj reconstruction with rib graft

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• bilateral TMJ deformity
• patients medically compromised

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Egypt

Tanta, 3111, Egypt

Location

Study Officials

• Marwa T Ibrahim, Ass prof

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 6, 2025
• Study Start: August 10, 2024
• Primary Completion: October 10, 2024
• Study Completion: May 10, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

EG (1)