Evaluation of the Mental Foramen After Surgery Via Ultrasonography

NCT06661798 | Completed

• 1 other identifier: 27.02.2024-E.142577
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthognathic Surgery

Keywords

Mental foramen; orthognathic surgery; blood flow; ultrasonography

Outcome Measures

Primary Outcomes (1)

• Changes in blood flow in the mental foramen after orthognathic surgery

  From enrollment to 3 months after the end of surgery

Study Arms (1)

Orthognathic surgery

OTHER

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; Procedure: USG examination; Procedure: Subjective evaluation - Neuro-sensitivity tests

Interventions

orthognathic surgery PROCEDURE

Mandibular setback, Maxillary advancement, Bilateral sagital split osteotomy

Orthognathic surgery

USG examination PROCEDURE

Comparison of blood flow in the mental foramen before and 1week, 1 month and 3 month after orthognathic surgery using ultrasound examination

Orthognathic surgery

Subjective evaluation - Neuro-sensitivity tests PROCEDURE

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).

Orthognathic surgery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Orthognathic Surgery

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: October 1, 2024
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: July 15, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)