Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery

NCT ID: NCT02658305

Last Updated: 2016-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prognathism Retrognathia Jaw Abnormalities

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

transoral group

orthognathic patients that were treated with a transoral surgical approach

No interventions assigned to this group

transbuccal group

orthognathic patients that were treated with a transbuccal surgical approach

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AZ Sint-Jan AV

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Johan Abeloos

Maxillofacial surgeon, Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johan Abeloos, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

General Hospital Saint-John Bruges

Bruges, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B049201525558

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Miniscrews Placement for Orthodontic Anchorage
NCT06635304 ACTIVE_NOT_RECRUITING