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Minimally Invasive Sagittal Split Ramus Osteotomy

T

TC Erciyes University

Status

Completed

Conditions

Orthognathic Surgical Procedures

Treatments

Procedure: Minimally Invasive Sagittal Split Ramus Osteotomy
Procedure: Conventional Sagittal Split Ramus Osteotomy

Study type

Interventional

Funder types

Other

Identifiers

NCT07118605
2024/110

Details and patient eligibility

About

This randomized, double-blind, controlled, split-mouth clinical trial investigates the effects of two different surgical approaches - the conventional technique and a minimally invasive technique - during bilateral sagittal split ramus osteotomy (SSRO) for mandibular deformity correction. The study will be conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Erciyes University.

Each patient will receive both surgical techniques, randomly assigned to either side of the mandible. All procedures will be performed under general anesthesia by the same surgeon. Intraoperative outcomes including bleeding volume and operative time will be recorded. Postoperative evaluations will be conducted on day 1, weeks 1, 2, and 4, and at 3 months to assess pain and swelling.

This study aims to determine whether the minimally invasive SSRO technique can improve surgical efficiency and reduce postoperative morbidity compared to the conventional approach, without compromising treatment outcomes.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients who underwent sagittal split ramus osteotomy for mandibular dentofacial deformity
  • Patients classified as ASA I or II
  • Patients over 18 years of age

Exclusion criteria

  • Patients with uncontrolled diabetes
  • Patients with metabolic bone diseases (e.g., hyperparathyroidism, Paget's disease)
  • Patients with syndromic conditions (e.g., Pierre Robin syndrome, Treacher Collins syndrome)
  • Patients who had previously undergone mandibular surgery due to trauma, tumors, or cysts and had sequelae involving the lower jaw

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

36 participants in 2 patient groups

Minimally Invasive Sagittal Split Ramus Osteotomy
Experimental group
Treatment:
Procedure: Minimally Invasive Sagittal Split Ramus Osteotomy
Conventional Sagittal Split Ramus Osteotomy
Active Comparator group
Treatment:
Procedure: Conventional Sagittal Split Ramus Osteotomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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