Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skel… (NCT07746700) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Clinical and Radiographic Evaluation of Low Sagittal Medial Ramus Osteotomy for Treatment of Skeletal Class II and Class III Malocclusion
11 participantsStarted 2026-09
Plain-language summary
This prospective clinical trial aims to evaluate the clinical and radiographic outcomes of the low sagittal medial ramus osteotomy-a technical modification of the conventional sagittal split osteotomy (SSO)-for treating patients with skeletal Class II and Class III malocclusions.
Standard sagittal split osteotomies carry risks of complications, including unfavorable osteotomy propagation (bad splits) toward the condyle, ramus fragmentation, lingual interference of the distal segment, and inferior alveolar nerve (IAN) injury. To minimize these risks, this study utilizes a modified medial cut positioned low (below the lingula in an area with adequate marrow space) and short (terminating anterior to the lingula). This design aims to prevent osteotomy extension into the condylar region and eliminate lingual interference during segment repositioning.
Who can participate
Age range
18 Years – 45 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 skeletal Class II or Class III malocclusion requiring mandibular orthognathic surgery.
* Age range from 18 to 45 years old.
* Systematically healthy patients classified as ASA physical status I or II (American Society of Anesthesiologists)
Exclusion Criteria:
* Patients with a pre-existing history of inferior alveolar nerve (IAN) sensory impairment.
* Patients with active or severe degenerative joint disease (DJD).
* Patients with a prior history of orthognathic surgical procedures.
* Patients presenting with systemic diseases or conditions known to compromise normal bone healing.
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
Number of Participants with Unfavorable Osteotomy Split ("Bad Split")
Timeframe: Intraoperative (during the surgical procedure)