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

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: A Randomized Controlled Trial.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Orthognathic Surgery
• Intervention / Treatment: Procedure: minimally invasive maxillary fixation; Procedure: Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud H Khorshed, MSc; Phone Number: 00201002007644; Email: mahmoud.khorshed@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; Maxilla fixation using custom plates on nasal buttress only via minimally invasive approach.	Procedure: minimally invasive maxillary fixation; 3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress; Other Names: 2 plates maxillary fixation
Active Comparator: control; Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.	linear measurement of discrepancy between both scans after superimposition	from preoperative plan to immediate postoperative (1 week)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans	linear measurement of discrepancy between both scans after superimposition	from enrollment to 6 month postoperative

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 3, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 31, 2025

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 16, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: orthognathic; minimally invasive; custom plate; nasal buttress
• Other Study ID Numbers: Omfs 3-3-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No