Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery

Prognathism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02658305
• Other study ID #: B049201525558
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: January 14, 2016
• Start date: October 2014
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Jaw Abnormalities
• Prognathism
• Retrognathia

Locations

Country	Name	City	State
Belgium	General Hospital Saint-John Bruges	Bruges

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications (rate of screw removal and/or infection)		within 4 weeks postoperative	Yes
Secondary	The value of demographic, dental and surgical parameters as potential risk factors for the occurence of postoperative complications		within 4 weeks postoperative	No