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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: minimally invasive maxillary fixation, Maxilla fixation using custom plates on nasal and zygomatic buttresses via conventional vestibular approach..
- Who it may be relevant to
- Registry conditions: Orthognathic Surgery. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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.
Overview
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.
Interventions
- Procedure minimally invasive maxillary fixation
3D printed patient specific custom plates minimally invasive maxillary fixation on nasal buttress - 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.
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- Stability of maxilla fixation by superimposing preoperative and 6months postoperative CT scans [Time frame: from enrollment to 6 month postoperative]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07311785 · Omfs 3-3-19