Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery

NCT02658305 | Completed

• 1 other identifier: B049201525558
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 1

Brief Summary

Bicortical screws have been widely used for mandibular osteosynthesis during orthognathic surgery.Transoral placement of bicortical screws is a rigid fixation method in orthognathic surgery, which is less often used. The aim of this study was to compare postoperative outcome of transoral versus transbuccal bicortical screw placement during orthognathic surgery. This study comprises an academic, retrospective, monocentric study in which the charts of orthognathic patients operated between January 2010 and December 2012 were retrospectively reviewed. Postoperative complications were registered. Demographic, dental and surgical parameters are examined as potential risk factors for the occurence of postoperative complications.

Conditions

Prognathism; Retrognathia; Jaw Abnormalities

Keywords

transoral approach; transbuccal approach; postoperative complications

Outcome Measures

Primary Outcomes (1)

• Postoperative complications (rate of screw removal and/or infection)

  within 4 weeks postoperative

Secondary Outcomes (1)

• The value of demographic, dental and surgical parameters as potential risk factors for the occurence of postoperative complications

  within 4 weeks postoperative

Study Arms (2)

transoral group

orthognathic patients that were treated with a transoral surgical approach

transbuccal group

orthognathic patients that were treated with a transbuccal surgical approach

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All orthognathic patients operated in the lower jaw between January 2010 and December 2012 at the Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Belgium

You may qualify if:

• patients of all ages
• patients of all genders
• patients who had undergone a bimaxillary osteotomy, a bilateral sagittal split ramus osteotomy (BSSO), a BSSO with a chin osteotomy or a trimaxillary osteotomy

You may not qualify if:

• patients where cement had been used at the osteotomy sites
• patients who had undergone a multisegmented mandibular osteotomy
• patients who had undergone an osteosynthesis with plates
• patients where the postoperative orthopantomogram was unavailable
• patients where data regarding the type of screw placement was unavailable

Sponsors & Collaborators

• AZ Sint-Jan AV: lead

Study Sites (1)

General Hospital Saint-John Bruges

Bruges, Belgium

Location

MeSH Terms

Conditions

Prognathism; Retrognathia; Jaw Abnormalities; Postoperative Complications

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Mandibular Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Johan Abeloos, MD

  Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maxillofacial surgeon, Head of Department

Study Record Dates

• First Submitted: January 11, 2016
• First Posted: January 18, 2016
• Study Start: October 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 18, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)