Effects of Low Medial Ramus Osteotomy on Neurosensorial Recovery During Post-Operative Period

Effects of Low Medial Ramus Osteotomy Performed During Bilateral Sagittal Split Osteotomy on Neurosensorial Recovery During Post-Operative Period

The aim of this study is to compare the post-operative neurosensorial disturbances of Hunsuck-Epkerr and "low and short medial osteotomy" modifications of sagittal split ramus osteotomy. Patients at the ages of 18-35 with dentofacial deformity who applied for orthognathic surgery were included in the present study. The present study performed with split-mouth randomised controlled trial design, therefore osteotomies on one side were performed with Hunscuk-Epkerr modification and the contralateral side with low and short medial osteotomy modification. Double blinded evaluations of neuro sensorial alterations were performed at the 1st, 3rd and 6th months post-operatively. Painful stimuli, two-point discrimination, pressure and brush stroke direction tests were evaluated. Subjective neurosensorial recovery was also evaluated with VAS scores given by patients.

Study Overview

• Status: Completed
• Conditions: Orthognathic Surgical Procedures
• Intervention / Treatment: Procedure: Bilateral Sagittal Split Osteotomy

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • İstanbul, Turkey, 34093
    • Bezmialem Vakif University

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients with dentofacial deformity who needs orthognatic surgery

Exclusion Criteria:

• The patients with medical conditions that may affect the potential of nerve regeneration,
• The patient who need additional osteotomies such as genioplasty or mandibular subapical segmental osteotomies
• The patients with bad split or interrupted IAN
• The patients with more than 5 mm expected buccal osseous gap between proximal and distal segments

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hunsuck-Epker Modification; A kind of ostoeotomy modification used during bilateral sagittal	Procedure: Bilateral Sagittal Split Osteotomy; A surgical procedure to correct dentofacial deformities
Experimental: Low and short medial osteotomy; A kind of ostoeotomy modification used during bilateral sagittal	Procedure: Bilateral Sagittal Split Osteotomy; A surgical procedure to correct dentofacial deformities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Sensory Recovery	Kind of scale, calculated with different neurosensorial investigation methods. Scored between S0-S4. S0 means total sensory loss, S4 means total sensory recovery.	6 months

Collaborators and Investigators

• Sponsor: Ali Törel Saygı

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2024
• Study Completion (Actual): June 30, 2024

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): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: orthognathic surgery; osteotomy modification
• Other Study ID Numbers: 22/3

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