CompletedNot Applicable

Evaluation of the Mental Foramen After Surgery Via Ultrasonography

Turkey (Türkiye)16 participantsStarted 2024-10-01

Plain-language summary

Objective: This study aims to detect changes in blood flow in the mental foramen after surgery compared to before orthognathic surgery. Materials and Methods: This study will include a total of 16 patients, aged between 18-60, who were planned for orthognathic surgery due to malocclusion complaints. Patients will be evaluated clinically and radiologically before surgery, 1 week, 1 month, and 3 months after the surgery. Panoramic radiographs will be taken before surgery and 3 months after surgery, and a fractal analysis of the ROI area determined distal to the mental foramen will be performed. Pain will be scored from 1 to 5 using the Pinprick test before surgery, 1 week, 1 month, and 3 months after surgery, while pressure and neurosensitivity will be scored using VAS. Neurosensory evaluation will be performed using two-point discrimination (dividing the area between the lower lip and chin into 9 regions), and left-right discrimination will be checked using the brush test. Blood flow in the mental foramen will be evaluated using ultrasonography.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

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Inclusion criteria

. Patients over 18 years old,
. Patients who have reached skeletal maturity,
. Patients under 60 years old,
. Patients with skeletal Class II malocclusion indicated for orthognathic surgery,
. Patients with skeletal Class III malocclusion indicated for orthognathic surgery,
. Those who are willing to participate in the study

Exclusion criteria

. Patients with a systemic 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.

What they're measuring

Changes in blood flow in the mental foramen after orthognathic surgery

Timeframe: From enrollment to 3 months after the end of surgery

Trial details

NCT IDNCT06661798

SponsorBezmialem Vakif University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-28

View on ClinicalTrials.gov More Orthognathic Surgery trials