CClinicalTrials.gg
CompletedNCT06662331Updated Oct 28, 2024

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

An interventional study of Bilateral Sagittal Split Osteotomy in Orthognathic Surgical Procedures, sponsored by Ali Törel Saygı. Completed at 1 site in Turkey. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Ali Törel Saygı · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Jan 2023, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Orthognathic Surgical Procedures

Keywords

  • orthognathic surgery
  • osteotomy modification
03

In context

Lead sponsor

This is the only study on the registry with Ali Törel Saygı as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with dentofacial deformity who needs orthognatic surgery

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    Hunsuck-Epker Modification

    A kind of ostoeotomy modification used during bilateral sagittal

    Procedure: Bilateral Sagittal Split Osteotomy

  • Experimental
    Low and short medial osteotomy

    A kind of ostoeotomy modification used during bilateral sagittal

    Procedure: Bilateral Sagittal Split Osteotomy

Interventions

  • ProcedureBilateral Sagittal Split Osteotomy

    A surgical procedure to correct dentofacial deformities

06

What researchers measure

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.

    Time frame: 6 months

07

Study locations

1 site
  • Bezmialem Vakif University
    İstanbul, 34093, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06662331
Lead sponsor
Ali Törel Saygı
Responsible party
Ali Törel Saygı (Corresponding Author, Bezmialem Vakif University) — Sponsor-investigator
First posted
Oct 28, 2024
Start date
Jan 1, 2023
Primary completion
Jun 30, 2024
Completion
Jun 30, 2024
Last update
Oct 28, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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