Custom Made Plate in Orthognathic Surgery

NCT ID: NCT06772688

Last Updated: 2025-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-03

Study Completion Date

2024-12-03

Brief Summary

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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

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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

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Maxillary Prognathism Maxillary Retrusion

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Fixation of maxilla with custom made plate designed by 3D virtual planning
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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designing of custom-made plate using 3Dvirtual planning

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

Group Type EXPERIMENTAL

orthognathic surgery

Intervention Type PROCEDURE

Maxillary repositioning and fixation with custom made plate

Interventions

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orthognathic surgery

Maxillary repositioning and fixation with custom made plate

Intervention Type PROCEDURE

Eligibility Criteria

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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 informed consent.

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 immunocompromised patient.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty of Dental Medicine for Girls

OTHER_GOV

Sponsor Role lead

Responsible Party

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Wafaa Anwar Mohamed Ali

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fatma ibrahim

Role: STUDY_DIRECTOR

professor of oral and maxillofacial surgery

Locations

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Faculty of dental medicine Azhar university

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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OR SUR-108-2-N

Identifier Type: -

Identifier Source: org_study_id

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