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Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02658305
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Johan Abeloos, AZ Sint-Jan AV

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
Prognathism Retrognathia Jaw Abnormalities

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Study Type : Observational
Actual Enrollment : 509 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Study Start Date : October 2014
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

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



Primary Outcome Measures :
  1. Postoperative complications (rate of screw removal and/or infection) [ Time Frame: 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 [ Time Frame: within 4 weeks postoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02658305


Locations
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Belgium
General Hospital Saint-John Bruges
Bruges, Belgium
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Johan Abeloos, MD Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
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Responsible Party: Johan Abeloos, Maxillofacial surgeon, Head of Department, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT02658305    
Other Study ID Numbers: B049201525558
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Johan Abeloos, AZ Sint-Jan AV:
transoral approach
transbuccal approach
postoperative complications
Additional relevant MeSH terms:
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Prognathism
Jaw Abnormalities
Retrognathia
Congenital Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Mandibular Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic Diseases
Stomatognathic System Abnormalities