CompletedNot Applicable

Minimally Invasive Sagittal Split Ramus Osteotomy

Turkey (Türkiye)36 participantsStarted 2024-02-19

Plain-language summary

This randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University. Each patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling. This study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.

Who can participate

Age range

18 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 who underwent sagittal split ramus osteotomy for mandibular dentofacial deformity * Patients classified as ASA I or II * Patients over 18 years of age Exclusion Criteria: * Patients with uncontrolled diabetes * Patients with metabolic bone diseases (e.g., hyperparathyroidism, Paget's disease) * Patients with syndromic conditions (e.g., Pierre Robin syndrome, Treacher Collins syndrome) * Patients who had previously undergone mandibular surgery due to trauma, tumors, or cysts and had sequelae involving the lower jaw

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

Operative Time

Timeframe: Intraoperative period (from skin incision to final suture placement)

Bleeding

Timeframe: Intraoperative period (from skin incision to final suture placement)

Trial details

NCT IDNCT07118605

SponsorTC Erciyes University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-07-25

View on ClinicalTrials.gov More Orthognathic Surgical Procedures trials