Temporomandibular JointNCT06811415
Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation
A study testing virtual temporomandibular joint reconstruction with costochondral graft in people with Temporomandibular Joint, run by Tanta University at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint
- What is being tested?
- virtual temporomandibular joint reconstruction with costochondral graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Aug 2024to 10 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- TMJ deformity due to osteoarthrosis, ankylosis, injury, and pathology
- medicaly free patients
Who cannot join
- bilateral TMJ deformity
- patients medically compromised
Trial locations and contacts
1 site in 1 country.
About this study
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
- Conditions
- Temporomandibular Joint
- Being tested
- virtual temporomandibular joint reconstruction with costochondral graft
- Keywords
- 3D printed templates, computer-assisted surgical simulation, costochondral graft, temporomandibular joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual temporomandibular joint reconstruction with costochondral graftProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: virtual temporomandibular joint reconstruction with costochondral graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
0 representing no pain and 10 representing the highest level of pain
Measured: 2 weeks
inflammation score scale
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
Measured: 1 month
Secondary outcomes (1)
mouth opening
normal ranged from 33 mm to 38 mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start10 Aug 2024
- Primary completion10 Oct 2024
- Study completion10 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Taha Ibrahim, Tanta University
- Investigators
- Marwa T Ibrahim, Ass prof, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811415
- Sponsor's protocol ID
- #R-OS-10-24-3149
- Status last verified
- Jun 2025
- First submitted
- 31 Jan 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tempromandibular Joint Reconstruction Via Computer-Assisted Surgery Simulation
- ClinicalTrials.gov ID
- NCT06811415
- Acronym / sponsor ID
- #R-OS-10-24-3149
- Conditions
- Temporomandibular Joint
- Keywords
- 3D printed templates, computer-assisted surgical simulation, costochondral graft, temporomandibular joint
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 10 Aug 2024 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 May 2025 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| virtual Tmj reconstruction with rib graft | Other | Procedure: virtual temporomandibular joint reconstruction with costochondral graftAll 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 |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- TMJ deformity due to osteoarthrosis, ankylosis, injury, and pathology
- medicaly free patients
Key exclusion criteria (2 listed)
- bilateral TMJ deformity
- patients medically compromised
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual temporomandibular joint reconstruction with costochondral graftAll 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 or surgery | virtual Tmj reconstruction with rib graft |
Primary outcome
visual analogue scale
Time frame: 2 weeks
0 representing no pain and 10 representing the highest level of pain
inflammation score scale
Time frame: 1 month
0 no inflammation, 1-3 mild inflammation,4-7 moderate inflammation,8-10 severe inflammation
1 secondary outcome
mouth opening
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marwa T Ibrahim, Ass prof principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual temporomandibular joint reconstruction with costochondral graft in people with Temporomandibular Joint, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.