Evaluating the Accuracy of Soft Tissue Prediction in Patients With Mandibular Prognathism After O… (NCT06724497) | Clinical Trial Compass
By InvitationPhase 1/2
Evaluating the Accuracy of Soft Tissue Prediction in Patients With Mandibular Prognathism After Orthognathic Surgery Using Handheld Scanner Versus Optical Scanner A Prospective Clinical Trial
Egypt11 participantsStarted 2024-09-24
Plain-language summary
Aim of study: To evaluate the accuracy of soft tissue prediction in orthognathic surgery using handheld scanners versus optical scanners.
Research hypothesis (null hypothesis): there is no difference in prediction accuracy between laser scans and handheld scans.
Primary objective: To evaluate The Accuracy of soft tissue prediction in orthognathic surgery using handheld scanner versus laser scanner
.
Secondary objective:
To evaluate scanning time, cost efficiency, and ease of use. patients will be treated from mandibular prognathism using only mandibular set back or bimaxillary surgery After six months postoperatively, 3D facial scans is obtained and exported to software to perform superimposition of the predicted and post operative results to assess the accuracy of soft tissue prediction By measuring the difference in millimeter between prespecified points
Who can participate
Age range
18 Years – 50 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:
* • Patients with facial mandibular prognathism that requires orthognathic surgery.
* Age (18- 50 years).
* Patients are willing for the surgical procedure and follow-up, with informed consent
Exclusion Criteria:
* • Dental malocclusion that could be treated with orthodontic treatment only.
* Patients with contraindications for general anesthesia.
* Patient on radiotherapy.
* Patients suffer from bone disease
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.