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Completed

NCT Number: NCT06662331

Effects of Low Medial Ramus 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.

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Key information

Conditions

Orthognathic Surgical Procedures

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

bilateral sagittal split osteotomy

Procedure

A surgical procedure to correct dentofacial deformities

Primary outcomes

  1. Functional Sensory Recovery

    Time frame: 6 months

    Kind of scale, calculated with different neurosensorial investigation methods. Scored between S0-S4. S0 means total sensory loss, S4 means total sensory recovery.

Sponsors and collaborators

Lead sponsor

Ali Törel Saygı

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 28, 2024
Registry last updated
Oct 28, 2024

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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