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CompletedNCT06811415Updated Jul 1, 2025

Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation

An interventional study of virtual temporomandibular joint reconstruction with costochondral graft in Temporomandibular Joint, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 15 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-01.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Aug 2024, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
15 Years to 45 Years
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • Temporomandibular Joint

Keywords

  • 3D printed templates
  • computer-assisted surgical simulation
  • costochondral graft
  • temporomandibular joint
03

In context

Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • bilateral TMJ deformity
  • patients medically compromised
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Other
    virtual Tmj reconstruction with rib graft

    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

  • Procedurevirtual temporomandibular joint reconstruction with costochondral graft

    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

06

What researchers measure

Primary outcomes

  1. visual analogue scale

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

    Time frame: 2 weeks

  2. inflammation score scale

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

    Time frame: 1 month

Secondary outcomes

  1. mouth opening

    normal ranged from 33 mm to 38 mm

    Time frame: 6 months

07

Study locations

1 site
  • Egypt
    Tanta, 3111, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06811415
Lead sponsor
Tanta University
Responsible party
Marwa Taha Ibrahim (Assistant professor, Tanta University) — Principal investigator
First posted
Feb 6, 2025
Start date
Aug 10, 2024
Primary completion
Oct 10, 2024
Completion
May 10, 2025
Last update
Jul 1, 2025

Study contacts

Marwa T Ibrahim, Ass prof
principal investigator · Tanta University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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