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Completed

NCT Number: NCT06661798

Evaluation of the Mental Foramen After Surgery Via Ultrasonography

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.

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Key information

Conditions

Orthognathic Surgery

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, Fatih, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Orthognathic Surgery

Procedure

Mandibular setback, Maxillary advancement, Bilateral sagital split osteotomy

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

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).

Primary outcomes

  1. Changes in blood flow in the mental foramen after orthognathic surgery

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

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Acronym: Blood flow

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2024
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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