Orthognathic Surgical ProceduresNCT07671794
Maxillary Positioning in Orthognathic Surgery
A study testing Maxillary Orthognathic Surgery in people with Orthognathic Surgical Procedures and Patient Specific Implant, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Patient that need corrective Jaw Surgery went into Maxillary Positioning in one of two groups either Maxilla Fixed using occlusal waver or PSI Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Orthognathic Surgical Procedures, Patient Specific Implant
- What is being tested?
- Maxillary Orthognathic Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2026to 1 Jul 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Medically compromised patients.
- Uncooperative or noncompliant patients.
- Patients with poor oral hygiene or active periodontal disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Accuracy of Maxillary Positioning Using Patient Specific Implant Versus Occlusal Splint in Orthognathic Surgery (A Randomized Clinical Trial)
Patient that need corrective Jaw Surgery went into Maxillary Positioning in one of two groups either Maxilla Fixed using occlusal waver or PSI
- Being tested
- Maxillary Orthognathic Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary Orthognathic SurgeryProcedure or surgery
Maxillary Positioning using PSI or Occlusal Waver
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Experimental | Fixation with normal plates Receives: Procedure: Maxillary Orthognathic Surgery |
| Interventional Group | Experimental | Fixation with PSI Receives: Procedure: Maxillary Orthognathic Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Maxillary Positioning
Superimposition of the preoperative plan and the postoperative result on the CT (Digital Measurement in the X, Y and Z axis in millimeters )
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2026
- Study start15 Jun 2026
- Primary completion30 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic Surgical ProceduresStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanoub Sliem, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07671794
- Sponsor's protocol ID
- Oral & Maxillofacial Surgery
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Maxillary Positioning Using Patient Specific Implant Versus Occlusal Splint in Orthognathic Surgery (A Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07671794
- Acronym / sponsor ID
- Oral & Maxillofacial Surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 26 Jun 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.
Patient that need corrective Jaw Surgery went into Maxillary Positioning in one of two groups either Maxilla Fixed using occlusal waver or PSI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Experimental | Procedure: Maxillary Orthognathic SurgeryFixation with normal plates |
| Interventional Group | Experimental | Procedure: Maxillary Orthognathic SurgeryFixation with PSI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Medically compromised patients.
- Uncooperative or noncompliant patients.
- Patients with poor oral hygiene or active periodontal disease.
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 |
|---|---|---|
| Maxillary Orthognathic SurgeryMaxillary Positioning using PSI or Occlusal Waver | Procedure or surgery | Control Group, Interventional Group |
Primary outcome
Accuracy of Maxillary Positioning
Time frame: 1 years
Superimposition of the preoperative plan and the postoperative result on the CT (Digital Measurement in the X, Y and Z axis in millimeters )
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 26 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary Orthognathic Surgery in people with Orthognathic Surgical Procedures and Patient Specific Implant, run by Future University in Egypt 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 0 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: enrolling by invitation, as of the sponsor's last update on 26 Jun 2026. 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?
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?
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?
Accuracy of Maxillary Positioning (time frame: 1 years). 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 26 Jun 2026.