Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic SurgeryNCT07344441
Accuracy of Patient Specific 3D Printed Titanium Plates Versus Milled Titanium Plates in Genioplasty Orthognathic Surgeries.
A study testing genioplasty using 3D printed patient specific titanium plates (study group) in people with Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgery and Patient Specific Genioplasty, run by Cairo University.
Trial summary
To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery Read more about this study
- Who is it for?
- Ages 19 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgery, Patient Specific Genioplasty, Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty
- What is being tested?
- genioplasty using 3D printed patient specific titanium plates (study group)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 15 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Who cannot join
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
- Patients with systemic condition contraindicating with the surgical procedure as uncontrolled diabetes
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Accuracy of Patient Specific 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgeries. A Randomized Controlled Clinical Trial
To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery
Read the detailed description
the first treatment include treating patients with 3D printed titanium plates while the second treatment include treating patients with 3D milled titanium plates in genioplasty orthognathic surgery and assess the accuracy between the two treatments
- Conditions
- Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgery, Patient Specific Genioplasty, Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty
- Being tested
- genioplasty using 3D printed patient specific titanium plates (study group), genioplasty using 3D milled patient specific titanium plates (control group)
- Keywords
- accuracy of 3D printed titanium plates versus 3D milled titanium plates in genioplasty, patient specific genioplasty, patient specific 3D printed titanium plates genioplasty, patient specific 3D milled titanium plates genioplasty, genioplasty orthognathic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
genioplasty using 3D printed patient specific titanium plates (study group)Procedure or surgery
genioplasty using 3D printed patient specific titanium plates (study group) the treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery
genioplasty using 3D milled patient specific titanium plates (control group)Procedure or surgery
genioplasty using 3D milled patient specific titanium plates (control group) The treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Experimental : genioplasty using 3D printed patient specific titanium plates (study group) The first treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery Receives: Procedure: genioplasty using 3D printed patient specific titanium plates (study group) |
| control Group | Experimental | Experimental : genioplasty using 3D milled patient specific titanium plates (study group) The second treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery Receives: Procedure: genioplasty using 3D milled patient specific titanium plates (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
Accuracy of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty measure The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual post-operative CBCT scans.
the measurement tool is CBCT scans superimposition in mm
Measured: immediately postoperative
Secondary outcomes (1)
stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
stability of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual 6 months post-operative CBCT scans.
the measurement tool is CBCT scans superimposition in mm
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Nov 2026 (estimated)
- Primary completion10 May 2027 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- the treatment include fixing the chin in genioplasty orthognathic surgery with 3D printed patient specific titanium plates
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina ElHadidi Sobhi Ramzi Michael, Cairo University
- Investigators
- Mohamed Mounir Shaker, Study chair, Cairo UniversityRofaida Atef Abaas, Study director, Cairo UniversityMohamed Ali Zain El Abdeen Abd El Wahab, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07344441
- Sponsor's protocol ID
- patient specific genioplasty
- Status last verified
- Jan 2026
- First submitted
- 26 Dec 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hanafy M, Akoush Y, Abou-ElFetouh A, Mounir RM. Precision of orthognathic digital plan transfer using patient-specific cutting guides and osteosynthesis versus mixed analogue-digitally planned surgery: a randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2020 Jan;49(1):62-68. doi: 10.1016/j.ijom.2019.06.023. Epub 2019 Jun 29.
PubMed 31262680Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.
PubMed 22337427Kusnoto B. Two-dimensional cephalometry and computerized orthognathic surgical treatment planning. Clin Plast Surg. 2007 Jul;34(3):417-26. doi: 10.1016/j.cps.2007.04.005.
PubMed 17692701
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Patient Specific 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgeries. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07344441
- Acronym / sponsor ID
- patient specific genioplasty
- Conditions
- Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgery, Patient Specific Genioplasty, Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty
- Keywords
- accuracy of 3D printed titanium plates versus 3D milled titanium plates in genioplasty, patient specific genioplasty, patient specific 3D printed titanium plates genioplasty, patient specific 3D milled titanium plates genioplasty, genioplasty orthognathic surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 15 Jan 2026 (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.
To assess accuracy of patient specific 3D printed titanium plates versus 3D milled titanium plates in genioplasty orthognathic surgery
Detailed description
the first treatment include treating patients with 3D printed titanium plates while the second treatment include treating patients with 3D milled titanium plates in genioplasty orthognathic surgery and assess the accuracy between the two treatments
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- the treatment include fixing the chin in genioplasty orthognathic surgery with 3D printed patient specific titanium plates
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Procedure: genioplasty using 3D printed patient specific titanium plates (study group)Experimental : genioplasty using 3D printed patient specific titanium plates (study group) The first treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery |
| control Group | Experimental | Procedure: genioplasty using 3D milled patient specific titanium plates (control group)Experimental : genioplasty using 3D milled patient specific titanium plates (study group) The second treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Key exclusion criteria (4 listed)
- Patients who refused to be included in the research.
- Patients with systemic diseases that may hinder the normal healing process or render the patient not fitting for general anaesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
- Patients with systemic condition contraindicating with the surgical procedure as uncontrolled diabetes
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 |
|---|---|---|
| genioplasty using 3D printed patient specific titanium plates (study group)genioplasty using 3D printed patient specific titanium plates (study group) the treatment plan includes fixing the chin with 3D printed patient specific titanium plates in genioplasty orthognathic surgery | Procedure or surgery | Study Group |
| genioplasty using 3D milled patient specific titanium plates (control group)genioplasty using 3D milled patient specific titanium plates (control group) The treatment plan includes fixing the chin with 3D milled patient specific titanium plates in genioplasty orthognathic surgery | Procedure or surgery | control Group |
Primary outcome
Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
Time frame: immediately postoperative
Accuracy of manufacturing of the patient specific customized 3D printed titanium plates in the study group versus milled titanium plates in the control group in genioplasty measure The skull base in the virtual surgical plan was superimposed using point-based matching ICP registration using anatomical reference points, followed by manual surface-based registration to surface best fit with the skull base in the actual post-operative CBCT scans. the measurement tool is CBCT scans superimposition in mm
1 secondary outcome
stability of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty
Time frame: 6 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 31262680Hanafy M, Akoush Y, Abou-ElFetouh A, Mounir RM. Precision of orthognathic digital plan transfer using patient-specific cutting guides and osteosynthesis versus mixed analogue-digitally planned surgery: a randomized controlled clinical trial. Int J Oral Maxillofac Surg. 2020 Jan;49(1):62-68. doi: 10.1016/j.ijom.2019.06.023. Epub 2019 Jun 29.
- Background: PubMed 22337427Levine JP, Patel A, Saadeh PB, Hirsch DL. Computer-aided design and manufacturing in craniomaxillofacial surgery: the new state of the art. J Craniofac Surg. 2012 Jan;23(1):288-93. doi: 10.1097/SCS.0b013e318241ba92.
- Background: PubMed 17692701Kusnoto B. Two-dimensional cephalometry and computerized orthognathic surgical treatment planning. Clin Plast Surg. 2007 Jul;34(3):417-26. doi: 10.1016/j.cps.2007.04.005.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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.
Mohamed Mounir Shaker study chair
Cairo University
Rofaida Atef Abaas study director
Cairo University
Mohamed Ali Zain El Abdeen Abd El Wahab study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing genioplasty using 3D printed patient specific titanium plates (study group) in people with Accuracy of 3D Printed Titanium Plates Versus 3D Milled Titanium Plates in Genioplasty Orthognathic Surgery and Patient Specific Genioplasty, run by Cairo University.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mina ElHadidi Sobhi Ramzi (+201225339712, mina.ramzi@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of manufacturing of the patient specific 3D printed titanium plates versus milled titanium plates in genioplasty (time frame: immediately postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07344441, which also lists 3 linked publications.
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 15 Jan 2026.