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Completed

NCT Number: NCT06811415

Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation

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.

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Key information

Conditions

Temporomandibular Joint

Age range

15 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Egypt

Tanta, 3111, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • bilateral TMJ deformity
  • patients medically compromised

Treatment and study plan

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

Primary outcomes

  1. visual analogue scale

    Time frame: 2 weeks

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

  2. inflammation score scale

    Time frame: 1 month

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

Secondary outcomes

  1. mouth opening

    Time frame: 6 months

    normal ranged from 33 mm to 38 mm

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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