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

NCT06662331 | Completed

• 1 other identifier: 22/3
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthognathic Surgical Procedures

Keywords

orthognathic surgery; osteotomy modification

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Hunsuck-Epker Modification

EXPERIMENTAL

A kind of ostoeotomy modification used during bilateral sagittal

Procedure: Bilateral Sagittal Split Osteotomy

Low and short medial osteotomy

EXPERIMENTAL

A kind of ostoeotomy modification used during bilateral sagittal

Procedure: Bilateral Sagittal Split Osteotomy

Interventions

Bilateral Sagittal Split Osteotomy PROCEDURE

A surgical procedure to correct dentofacial deformities

Hunsuck-Epker Modification; Low and short medial osteotomy

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with dentofacial deformity who needs orthognatic surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Ali Törel Saygı: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Corresponding Author

Model Details: Double Blind

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 28, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)