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Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery

Sponsor
AZ Sint-Jan AV (Other)
Overall Status
Completed
CT.gov ID
NCT02658305
Collaborator
(none)
509
Enrollment
1
Location
13
Duration (Months)
39.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    509 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Study Start Date :
    Oct 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2015
    Actual Study Completion Date :
    Nov 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    transoral group

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

    orthognathic patients that were treated with a transbuccal surgical approach

    Outcome Measures

    Primary Outcome Measures

    1. Postoperative complications (rate of screw removal and/or infection) [within 4 weeks postoperative]

    Secondary Outcome Measures

    1. The value of demographic, dental and surgical parameters as potential risk factors for the occurence of postoperative complications [within 4 weeks postoperative]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital Saint-John Bruges Bruges Belgium

    Sponsors and Collaborators

    • AZ Sint-Jan AV

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johan Abeloos, Maxillofacial surgeon, Head of Department, AZ Sint-Jan AV
    ClinicalTrials.gov Identifier:
    NCT02658305
    Other Study ID Numbers:
    • B049201525558
    First Posted:
    Jan 18, 2016
    Last Update Posted:
    Jan 18, 2016
    Last Verified:
    Jan 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Johan Abeloos, Maxillofacial surgeon, Head of Department, AZ Sint-Jan AV
    transoral approach
    transbuccal approach
    postoperative complications
    Additional relevant MeSH terms:
    Prognathism
    Retrognathia
    Jaw Abnormalities

    Study Results

    No Results Posted as of Jan 18, 2016