Orthognathic SurgeryNCT07311785
Accuracy of Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries
A study testing minimally invasive maxillary fixation and Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach. in people with Orthognathic Surgery, run by Cairo University.
Trial summary
The goal of this clinical trial is to evaluate of the accuracy maxilla fixation using custom plates on nasal buttress only via minimally invasive approach versus using custom plates on nasal and zygomatic buttresses via conventional approach. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- minimally invasive maxillary fixation and Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Jun 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
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 Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries: A Randomized Controlled Trial.
The goal of this clinical trial is to evaluate of the accuracy maxilla fixation using custom plates on nasal buttress only via minimally invasive approach versus using custom plates on nasal and zygomatic buttresses via conventional approach. The main question it aims to answer is:
- Is the minimally invasive approach accurate and stable ? Researchers will compare minimally invasive technique to the traditional technique of fixation of the maxilla bone to see if it is as accurate and stable.
Participants will:
- Undergo surgey
- Follow up visits weekly for a month then on a monthly basis for 5 more months.
- Conditions
- Orthognathic Surgery
- Being tested
- minimally invasive maxillary fixation, Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.
- Keywords
- orthognathic, minimally invasive, nasal buttress, custom plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive maxillary fixationProcedure or surgery
Also called 2 plates maxillary fixation
3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress
Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.Procedure or surgery
3d printed custom plates fixing maxilla on nasal and zygomatic buttresses via conventional vestibular approach.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Maxilla fixation using custom plates on nasal buttress only via minimally invasive approach. Receives: Procedure: minimally invasive maxillary fixation |
| control | Active comparator | Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach. Receives: Procedure: Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.
linear measurement of discrepancy between both scans after superimposition
Measured: from preoperative plan to immediate postoperative (1 week)
Secondary outcomes (1)
Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans
linear measurement of discrepancy between both scans after superimposition
Measured: from enrollment to 6 month postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Hamid Khorshed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07311785
- Sponsor's protocol ID
- Omfs 3-3-19
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07311785
- Acronym / sponsor ID
- Omfs 3-3-19
- Conditions
- Orthognathic Surgery
- Keywords
- orthognathic, minimally invasive, nasal buttress, custom plate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 31 Dec 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.
The goal of this clinical trial is to evaluate of the accuracy maxilla fixation using custom plates on nasal buttress only via minimally invasive approach versus using custom plates on nasal and zygomatic buttresses via conventional approach. The main question it aims to answer is:
- Is the minimally invasive approach accurate and stable ? Researchers will compare minimally invasive technique to the traditional technique of fixation of the maxilla bone to see if it is as accurate and stable.
Participants will:
- Undergo surgey
- Follow up visits weekly for a month then on a monthly basis for 5 more months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Procedure: minimally invasive maxillary fixationMaxilla fixation using custom plates on nasal buttress only via minimally invasive approach. |
| control | Active comparator | Procedure: Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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 (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 anaesthesia.
- 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 |
|---|---|---|
| minimally invasive maxillary fixationAlso: 2 plates maxillary fixation3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress | Procedure or surgery | intervention |
| Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.3d printed custom plates fixing maxilla on nasal and zygomatic buttresses via conventional vestibular approach. | Procedure or surgery | control |
Primary outcome
Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.
Time frame: from preoperative plan to immediate postoperative (1 week)
linear measurement of discrepancy between both scans after superimposition
1 secondary outcome
Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans
Time frame: from enrollment to 6 month 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 31 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive maxillary fixation and Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach. in people with Orthognathic Surgery, 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 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: opening soon, as of the sponsor's last update on 31 Dec 2025. 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 Mahmoud H Khorshed, MSc (00201002007644, mahmoud.khorshed@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 the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans. (time frame: from preoperative plan to immediate postoperative (1 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 31 Dec 2025.