Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery

January 14, 2016 updated by: Johan Abeloos, AZ Sint-Jan AV

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

509

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruges, Belgium
        • General Hospital Saint-John Bruges

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
transoral group
orthognathic patients that were treated with a transoral surgical approach
transbuccal group
orthognathic patients that were treated with a transbuccal surgical approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative complications (rate of screw removal and/or infection)
Time Frame: within 4 weeks postoperative
within 4 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
The value of demographic, dental and surgical parameters as potential risk factors for the occurence of postoperative complications
Time Frame: within 4 weeks postoperative
within 4 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Investigators

  • Principal Investigator: Johan Abeloos, MD, Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

January 11, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 18, 2016

Study Record Updates

Last Update Posted (Estimate)

January 18, 2016

Last Update Submitted That Met QC Criteria

January 14, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B049201525558

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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