Maxillary PrognathismOGSNCT06772688
Custom Made Plate in Orthognathic Surgery
A study testing orthognathic surgery in people with Maxillary Prognathism and Maxillary Retrusion, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial summary
Orthognathic surgery has traditionally been used to correct dentofacial deformities. Conventional methods rely on 2D radiographic images, occlusal splints, and dental casts, but these approaches have limitations, such as errors during face-bow transfer. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Maxillary Prognathism, Maxillary Retrusion
- What is being tested?
- orthognathic surgery
- 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
- 3 Apr 2023to 3 Dec 2024
- 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with skeletal class II or class III who need orthognathic surgery.
- Patients who suffer from clinical facial asymmetry.
- Patients with occlusal plane canting.
- Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.
Who cannot join
- Maxillofacial trauma
- Patients who suffer from maxillofacial tumors
- Segmental maxillary surgery.
- Oral soft tissues defects, infections and bone metabolism disturbance.
- Allergy to titanium implant.
- Patient with systemic disease and immunocompromised patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Accuracy of Custom-made Plate in Maxillary Repositioning
Orthognathic surgery has traditionally been used to correct dentofacial deformities. Conventional methods rely on 2D radiographic images, occlusal splints, and dental casts, but these approaches have limitations, such as errors during face-bow transfer. Technological advancements, including 3D imaging, virtual surgical planning (VSP), and computer-aided design and manufacturing (CAD/CAM), have improved the precision and outcomes of orthognathic surgery.
Read the detailed description
This study included one group of patients need orthognathic surgery and fixation of maxilla using custom made plate designed by 3D virtual planning using Materialize mimic soft ware
- Conditions
- Maxillary Prognathism, Maxillary Retrusion
- Being tested
- orthognathic surgery
- Keywords
- Orthognathic surgery, Virtual planning, custom made plate
- Medical subject headings
- Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
orthognathic surgeryProcedure or surgery
Maxillary repositioning and fixation with custom made plate
| Study group | Role | What they receive |
|---|---|---|
| designing of custom-made plate using 3Dvirtual planning | Experimental | patients underwent maxillary Le Fort I osteotomy using custom made plates for repositioning and fixation. Receives: Procedure: orthognathic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the accuracy of custom-made plate
CT to measure the accuracy
Measured: immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start3 Apr 2023
- Primary completion12 Oct 2024
- Study completion3 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary PrognathismStudies 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
- Model description
- Fixation of maxilla with custom made plate designed by 3D virtual planning
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Wafaa Anwar Mohamed Ali, Faculty of Dental Medicine for Girls
- Investigators
- fatma ibrahim, Study director, professor of oral and maxillofacial surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06772688
- Sponsor's protocol ID
- OR SUR-108-2-N
- Acronym
- OGS
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Accuracy of Custom-made Plate in Maxillary Repositioning
- ClinicalTrials.gov ID
- NCT06772688
- Acronym / sponsor ID
- OGS / OR SUR-108-2-N
- Conditions
- Maxillary Prognathism, Maxillary Retrusion
- Keywords
- Orthognathic surgery, Virtual planning, custom made plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 12 Oct 2024 (actual)
- Study completion
- 3 Dec 2024 (actual)
- First posted
- 13 Jan 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.
Orthognathic surgery has traditionally been used to correct dentofacial deformities. Conventional methods rely on 2D radiographic images, occlusal splints, and dental casts, but these approaches have limitations, such as errors during face-bow transfer. Technological advancements, including 3D imaging, virtual surgical planning (VSP), and computer-aided design and manufacturing (CAD/CAM), have improved the precision and outcomes of orthognathic surgery.
Detailed description
This study included one group of patients need orthognathic surgery and fixation of maxilla using custom made plate designed by 3D virtual planning using Materialize mimic soft ware
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixation of maxilla with custom made plate designed by 3D virtual planning
| Arm | Type | Receives |
|---|---|---|
| designing of custom-made plate using 3Dvirtual planning | Experimental | Procedure: orthognathic surgerypatients underwent maxillary Le Fort I osteotomy using custom made plates for repositioning and fixation. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with skeletal class II or class III who need orthognathic surgery.
- Patients who suffer from clinical facial asymmetry.
- Patients with occlusal plane canting.
- Age range of patients 18-40 years old, with no gender prediction, able to read and sign the informed consent.
Key exclusion criteria (6 listed)
- Maxillofacial trauma
- Patients who suffer from maxillofacial tumors
- Segmental maxillary surgery.
- Oral soft tissues defects, infections and bone metabolism disturbance.
- Allergy to titanium implant.
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 |
|---|---|---|
| orthognathic surgeryMaxillary repositioning and fixation with custom made plate | Procedure or surgery | designing of custom-made plate using 3Dvirtual planning |
Primary outcome
Evaluation of the accuracy of custom-made plate
Time frame: immediate postoperative
CT to measure the accuracy
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 17 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Maxillary Prognathism
Recruiting
Nano Coated Orthodontic Miniscrews for en Mass Retraction of the Upper Arch
Class I Malocclusion, Maxillary Prognathism
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.
fatma ibrahim study director
professor of oral and maxillofacial surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing orthognathic surgery in people with Maxillary Prognathism and Maxillary Retrusion, run by Faculty of Dental Medicine for Girls 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 4 inclusion and 6 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 17 Jan 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?
Evaluation of the accuracy of custom-made plate (time frame: immediate postoperative). 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 17 Jan 2025; AzTrials last refreshed its copy on 31 Oct 2026.