Evaluation of the Mental Foramen After Surgery Via Ultrasonography (Blood flow)

Evaluation of Changes in Mental Foramen Blood Flow After Orthognathic Surgery Using Ultrasound

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.

Study Overview

• Status: Completed
• Conditions: Orthognathic Surgery
• Intervention / Treatment: Procedure: orthognathic surgery; Procedure: USG examination; Procedure: Subjective evaluation - Neuro-sensitivity tests

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Fatih
    • Istanbul, Fatih, Turkey, 34093
      • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Orthognathic surgery; Patients who have reached skeletal maturity, have skeletal Class II or Class III malocclusion, and are indicated for orthognathic surgery due to malocclusion complaints

Procedure: orthognathic surgery; Mandibular setback, Maxillary advancement, Bilateral sagital split osteotomy; Procedure: USG examination; Comparison of blood flow in the mental foramen before and 1week, 1 month and 3 month after orthognathic surgery using ultrasound examination; Procedure: Subjective evaluation - Neuro-sensitivity tests; Direction determination, two-point separation, pinprick, and brush tests, along with neurosensitivity VAS and pressure VAS, were applied to the patients. These tests were performed before surgery (T0), seven days after surgery (T1), one month after surgery (T2), and three months after surgery (T3).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in blood flow in the mental foramen after orthognathic surgery	From enrollment to 3 months after the end of surgery

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): March 28, 2025
• Study Completion (Actual): March 28, 2025

Study Registration Dates

• First Submitted: October 25, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 14, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: ultrasonography; blood flow; orthognathic surgery; Mental foramen
• Other Study ID Numbers: 27.02.2024-E.142577

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No