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Clinical Trials/NCT06661798
NCT06661798
Completed
Not Applicable

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

Bezmialem Vakif University1 site in 1 country16 target enrollmentOctober 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthognathic Surgery
Sponsor
Bezmialem Vakif University
Enrollment
16
Locations
1
Primary Endpoint
Changes in blood flow in the mental foramen after orthognathic surgery
Status
Completed
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2024
End Date
March 28, 2025
Last Updated
9 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Elifhan Alagoz

Assistant Professor

Bezmialem Vakif University

Eligibility Criteria

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,
  • 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

Outcomes

Primary Outcomes

Changes in blood flow in the mental foramen after orthognathic surgery

Time Frame: From enrollment to 3 months after the end of surgery

Study Sites (1)

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