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CompletedNCT06772688OGSUpdated Jan 17, 2025

Custom Made Plate in Orthognathic Surgery

An interventional study of orthognathic surgery in Maxillary Prognathism and Maxillary Retrusion, sponsored by Faculty of Dental Medicine for Girls. Completed at 1 site in Egypt. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2025-01-17.

Sponsored by Faculty of Dental Medicine for Girls · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Apr 2023, registered Jan 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
8
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
01

Study 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. 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

02

Conditions studied

  • Maxillary Prognathism
  • Maxillary Retrusion

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Keywords

  • Orthognathic surgery
  • Virtual planning
  • custom made plate
03

In context

Retrognathia

62 studies on the registry are indexed under Retrognathia; 15 are open to participants now.

This study's enrollment of 8 is below the median of 34 across 52 interventional studies indexed under Retrognathia.

Browse Retrognathia studies →

Lead sponsor

Faculty of Dental Medicine for Girls is the lead sponsor of 54 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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 patient.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    designing of custom-made plate using 3Dvirtual planning

    patients underwent maxillary Le Fort I osteotomy using custom made plates for repositioning and fixation.

    Procedure: orthognathic surgery

Interventions

  • Procedureorthognathic surgery

    Maxillary repositioning and fixation with custom made plate

06

What researchers measure

Primary outcomes

  1. Evaluation of the accuracy of custom-made plate

    CT to measure the accuracy

    Time frame: immediate postoperative

07

Study locations

1 site
  • Faculty of dental medicine Azhar university
    Cairo, 12345, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in Oct 2024, 18 months.

Of 30 interventional studies with no phase under Retrognathia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 35. This study's 18 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2025
First posted
Jan 13, 2025
StartActual
Apr 3, 2023
Primary completionActual
Oct 12, 2024
CompletionActual
Dec 3, 2024
Last update
Jan 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06772688
Lead sponsor
Faculty of Dental Medicine for Girls
Responsible party
Wafaa Anwar Mohamed Ali (Assistant lecturer, Faculty of Dental Medicine for Girls) — Principal investigator
First posted
Jan 13, 2025
Start date
Apr 3, 2023
Primary completion
Oct 12, 2024
Completion
Dec 3, 2024
Last update
Jan 17, 2025

Study contacts

fatma ibrahim
study director · professor of oral and maxillofacial surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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