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

NCT ID: NCT07311785

Last Updated: 2025-12-31

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Orthognathic Surgery

Keywords

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orthognathic minimally invasive nasal buttress custom plate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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intervention

Maxilla fixation using custom plates on nasal buttress only via minimally invasive approach.

Group Type EXPERIMENTAL

minimally invasive maxillary fixation

Intervention Type PROCEDURE

3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress

control

Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.

Group Type ACTIVE_COMPARATOR

Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.

Intervention Type PROCEDURE

3d printed custom plates fixing maxilla on nasal and zygomatic buttresses via conventional vestibular approach.

Interventions

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minimally invasive maxillary fixation

3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Other Intervention Names

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2 plates maxillary fixation

Eligibility Criteria

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Inclusion Criteria

* Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.
* Patients with no signs or symptoms of active TMDs.
* Highly motivated patients.

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Hamid Khorshed

oral & maxillofacial surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Mahmoud H Khorshed, MSc

Role: CONTACT

Phone: 00201002007644

Email: [email protected]

Other Identifiers

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Omfs 3-3-19

Identifier Type: -

Identifier Source: org_study_id