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NCT Number: NCT07311785

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

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.

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Key information

Conditions

Orthognathic Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

minimally invasive maxillary fixation

Procedure

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

Other names: 2 plates maxillary fixation

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

Procedure

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

Primary outcomes

  1. Accuracy of the maxilla fixation on CT compared to preoperative plan assessed by superimposition of preoperative and immediate postoperative scans.

    Time frame: from preoperative plan to immediate postoperative (1 week)

    linear measurement of discrepancy between both scans after superimposition

Secondary outcomes

  1. Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans

    Time frame: from enrollment to 6 month postoperative

    linear measurement of discrepancy between both scans after superimposition

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud H Khorshed, MSc

CONTACT

[email protected]

00201002007644

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 31, 2025
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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