Surgery-First Orthognathic Surgery in Skeletal Class III Treatment (NCT07433842) | Clinical Trial Compass
CompletedNot Applicable
Surgery-First Orthognathic Surgery in Skeletal Class III Treatment
Vietnam60 participantsStarted 2022-03-01
Plain-language summary
This study evaluates the efficacy and stability of the "Surgery-First" approach (SF approach) in treating patients with skeletal Class III malocclusion, utilizing a combined retrospective and prospective data collection method. Unlike the conventional method, the SF approach performs orthognathic surgery first to correct the skeletal discrepancy, followed by orthodontic treatment. The study aims to analyze pre-operative dentoskeletal characteristics, arch morphology, and treatment complexity indices, as well as assess the hard and soft tissue changes at 1 week and 1 year post-surgery using digital dental models and Computed Tomography (CT) scans.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patients aged 16 years or older, and male patients aged 18 years or older.
* Diagnosis of skeletal Class III malocclusion.
* Meeting the clinical indications for the Surgery-First orthognathic approach.
* Treatment plan consensus between the orthodontist and maxillofacial surgeon, aligned with the patient's chief complaint and expectations.
* Underwent orthognathic surgery using the Surgery-First approach without pre-surgical orthodontic treatment.
* Good general health, fit for general anesthesia.
* Voluntarily agreed to participate in the study and provided informed consent.
Exclusion Criteria:
* Dentofacial deformities secondary to maxillofacial trauma (e.g., midface retrusion due to Le Fort fractures, or mandibular retrusion due to bilateral condylar fractures).
* Presence of systemic diseases or conditions that contraindicate general anesthesia or orthognathic surgery.
* Presence of psychiatric disorders that may compromise treatment cooperation or the informed consent process.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Three-Dimensional Skeletal and Soft Tissue Changes on Computed Tomography (CT)