Orthognathic SurgeryNCT07418684
Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates
A study testing two customized titanium plates and four customized titanium plates in people with Orthognathic Surgery, run by Cairo University at 2 sites in Egypt.
Trial summary
In this research the investigators aim to minimize the use of more hardware in the fixation of the orthognathic surgery cases. The objective of this study is to assess the accuracy of the plan transfer with two customized titanium plates versus four customized titanium plates. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- two customized titanium plates and four customized titanium plates
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Mar 2025to 1 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- .Patients with dentofacial disharmony and misalignment requiring 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 anesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Mohamed Gamal Hammad, master degree contact
Egypt2 sites, 2 recruiting
- Recruiting
Cairo University
Cairo, 14444
Mohamed G. Hammad, MSc, 01000687772, mohamed.hammad@dentistry.cu.edu.eg
Youmna Alaa, 01008179819, yomna.alaa@dentistry.cu.edu.eg
- Recruiting
faculty of dentistry Cairo University
Cairo, 14444
Mohamed G. Hammad, MSc, 01000687772, mohamed.hammad@dentistry.cu.edu.eg
Youmna Alaa, 01008179819, yomna.alaa@dentistry.cu.edu.eg
About this study
Official title: Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates for Virtual Plan Transfer in Orthognathic Surgery. Randomized Clinical Trial.
In this research the investigators aim to minimize the use of more hardware in the fixation of the orthognathic surgery cases. The objective of this study is to assess the accuracy of the plan transfer with two customized titanium plates versus four customized titanium plates.
Read the detailed description
In orthognathic surgery cases, maxillary repositioning in three dimensions can be obtained. Recently using the custom-made plates instead of wafer used in classic models can get an accurate plan transfer, however it can get suboptimal accurate repositioning.
The aim of the study is to evaluate the accuracy of two customized titanium plates versus four customized titanium plates in transferring the virtual plan in orthognathic surgeries.
- Conditions
- Orthognathic Surgery
- Being tested
- two customized titanium plates, four customized titanium plates
- Keywords
- virtual surgical planning, Le fort 1, PSSO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
two customized titanium platesProcedure or surgery
Also called two titanium miniplates
two customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
four customized titanium platesProcedure or surgery
Also called four titanium miniplates
four customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field
| Study group | Role | What they receive |
|---|---|---|
| two customized titanium plates for virtual plan transfer in orthognathic surgery | Experimental | two customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field Receives: Procedure: two customized titanium plates |
| four customized titanium plates for virtual plan transfer in orthognathic surgery | Active comparator | four customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field Receives: Procedure: four customized titanium plates |
What is being measured
The primary outcome is the main question the study is designed to answer.
assessment of the accuracy of plan transfer
Specific measurement variable: 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 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.
Measured: within one week
Secondary outcomes (1)
patient satisfaction
A self-administered OQLQ translated into Arabic will be used to assess quality of life at the recruitment visit and six months after the surgery. Questions 1, 7, 10, 11, and 14 will be about facial aesthetics and appearance, questions 2 to 6 will be about oral function, questions 8, 9, 12, and 13 will be about the awareness of the deformity, and questions 15 to 22 will about the social aspect of the deformity.
The questionnaire contains 22 questions, and each question has score from 1 to 4, so each patient will have a score from 22 to 88.
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 posted18 Feb 2026
- Study start1 Mar 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- two customized titanium plates for virtual plan transfer in orthognathic surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed gamal hammad, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418684
- Sponsor's protocol ID
- 3-3-10
- Status last verified
- Oct 2026
- First submitted
- 22 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Maxillary Two Customized 3D Titanium Miniplates Versus Four Customized 3D Miniplates for Virtual Plan Transfer in Orthognathic Surgery. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT07418684
- Acronym / sponsor ID
- 3-3-10
- Conditions
- Orthognathic Surgery
- Keywords
- virtual surgical planning, Le fort 1, PSSO
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 18 Feb 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.
In this research the investigators aim to minimize the use of more hardware in the fixation of the orthognathic surgery cases. The objective of this study is to assess the accuracy of the plan transfer with two customized titanium plates versus four customized titanium plates.
Detailed description
In orthognathic surgery cases, maxillary repositioning in three dimensions can be obtained. Recently using the custom-made plates instead of wafer used in classic models can get an accurate plan transfer, however it can get suboptimal accurate repositioning.
The aim of the study is to evaluate the accuracy of two customized titanium plates versus four customized titanium plates in transferring the virtual plan in orthognathic surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two customized titanium plates for virtual plan transfer in orthognathic surgery
| Arm | Type | Receives |
|---|---|---|
| two customized titanium plates for virtual plan transfer in orthognathic surgery | Experimental | Procedure: two customized titanium platestwo customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field |
| four customized titanium plates for virtual plan transfer in orthognathic surgery | Active comparator | Procedure: four customized titanium platesfour customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- .Patients with dentofacial disharmony and misalignment requiring orthognathic surgeries.
- Patients with no signs or symptoms of active TMDs.
- Highly motivated patients.
Key exclusion criteria (3 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 anesthesia.
- Patients with intra-bony lesions or infections that may retard the osteotomy healing.
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 |
|---|---|---|
| two customized titanium platesAlso: two titanium miniplatestwo customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field | Procedure or surgery | two customized titanium plates for virtual plan transfer in orthognathic surgery |
| four customized titanium platesAlso: four titanium miniplatesfour customized titanium plates for virtual plan transfer in orthognathic surgery for accurate plan transfer to the surgical field | Procedure or surgery | four customized titanium plates for virtual plan transfer in orthognathic surgery |
Primary outcome
assessment of the accuracy of plan transfer
Time frame: within one week
Specific measurement variable: 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 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.
1 secondary outcome
patient satisfaction
Time frame: 6 months
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 20 Oct 2026.
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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.
Mohamed Gamal Hammad, master degree contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing two customized titanium plates and four customized titanium plates in people with Orthognathic Surgery, run by Cairo University at 2 sites 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Mohamed Gamal Hammad, master degree (01000687772 ext. 01000687772, mohamed.hammad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of the accuracy of plan transfer (time frame: within one week). 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 20 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.