Evaluation of the Mental Foramen After Surgery Via Ultrasonography

Not Applicable

Completed

• Conditions: Orthognathic Surgery

• Registration Number: NCT06661798
• Lead Sponsor: Bezmialem Vakif University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-01
• Study First Submitted: 2024-10-25
• Study First Submitted QC: 2024-10-25
• Study First Posted: 2024-10-28
• Primary Completion: 2025-03-28
• Study Completion: 2025-03-28
• Last Update Submitted: 2025-04-06
• Last Update Posted: 2025-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

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

Exclusion Criteria

1. Patients with cleft lip and palate,
2. Patients with craniofacial anomalies,
3. Patients with a systemic disease,
4. Patients under 18 years old,
5. Patients who have not completed their growth and development,
6. Patients over 59 years old,
7. Patients using neurological and psychiatric medications,
8. Patients who have previously undergone surgery or experienced trauma in the mandibular region,
9. Patients with neurosensory dysfunction in the inferior alveolar nerve before surgery,
10. Pregnant individuals or those suspected of being pregnant,
11. Any local or systemic condition that may contraindicate general anesthesia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in blood flow in the mental foramen after orthognathic surgery	From enrollment to 3 months after the end of surgery

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Fatih, Turkey