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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorCairo University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with dentofacial disharmony and misalignment requiring bimaxillary orthognathic surgeries.

Patients with no signs or symptoms of active TMDs.

Highly motivated patients.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • minimally invasive maxillary fixation

    Procedure/Surgery

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

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

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: interventionExperimental treatment 1 intervention
Group B: controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Secondary outcomes

1

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

linear measurement of discrepancy between both scans after superimposition

Time frame
from enrollment to 6 month postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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