PrognathismNCT02658305
Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery
An observational study of Prognathism and Retrognathia, run by AZ Sint-Jan AV at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prognathism, Retrognathia, Jaw Abnormalities
- How many people
- 509 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2014to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Prognathism, Retrognathia, Jaw Abnormalities
- Keywords
- transoral approach, transbuccal approach, postoperative complications
- Medical subject headings
- Prognathism, Retrognathia, Jaw Abnormalities, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications (rate of screw removal and/or infection)
Measured: within 4 weeks postoperative
Secondary outcomes (1)
The value of demographic, dental and surgical parameters as potential risk factors for the occurence of postoperative complications
Measured: within 4 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2016 (estimated)
- Study startOct 2014
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrognathismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 509 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZ Sint-Jan AV
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Abeloos, AZ Sint-Jan AV
- Investigators
- Johan Abeloos, MD, Principal investigator, Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02658305
- Sponsor's protocol ID
- B049201525558
- Status last verified
- Jan 2016
- First submitted
- 11 Jan 2016
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transoral Versus Transbuccal Placement of Bicortical Screws During Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT02658305
- Acronym / sponsor ID
- B049201525558
- Conditions
- Prognathism, Retrognathia, Jaw Abnormalities
- Keywords
- transoral approach, transbuccal approach, postoperative complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 509 participants (actual)
- Lead sponsor
- AZ Sint-Jan AVUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 18 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transoral group | – | –orthognathic patients that were treated with a transoral surgical approach |
| transbuccal group | – | –orthognathic patients that were treated with a transbuccal surgical approach |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative complications (rate of screw removal and/or infection)
Time frame: within 4 weeks postoperative
1 secondary outcome
The value of demographic, dental and surgical parameters as potential risk factors for the occurence of postoperative complications
Time frame: within 4 weeks postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johan Abeloos, MD principal investigator
Department of Oral and Maxillofacial Surgery, General Hospital Saint-John Bruges, Bruges, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prognathism and Retrognathia, run by AZ Sint-Jan AV at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (rate of screw removal and/or infection) (time frame: within 4 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2016.