Mandibular HypoplasiaNCT03710512
Evaluation of Early Relapse After Mandibular Lengthening Surgery
An observational study of Mandibular Hypoplasia and Relapse, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The goal of this study is to evaluate whether the use of a bone graft substitute at the osteotomy site will result in better stability and diminish early relapse after mandibular lengthening surgery. Read more about this study
- Who is it for?
- Ages 10 to 75 years
- Conditions the study is for
- Mandibular Hypoplasia, Relapse
- What is being tested?
- Bilateral sagittal split osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Sep 2018to 30 Dec 2019
- How long will I take part?
- 6 Months
- 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 10 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Class II occlusion of non-syndromic origin, mandibular hypoplasia
Who may be able to join
- Class II occlusion of non-syndromic origin, mandibular hypoplasia
- Availability of pre- and postoperative CBCT scans of sufficient quality
- Age: >10years
Who cannot join
- Previous orthognathic surgical treatment
- Simultaneously performed genioplasty
- Plate osteosynthesis
- Buccal plate fracture during surgery
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Vlaams Brabant, 1090
Veerle Van Mossevelde, Datanurse, +3224763134, veerle.vanmossevelde@uzbrussel.be
About this study
Official title: Evaluation of Early Relapse After Mandibular Lengthening Surgery With or Without the Use of a Bone Graft Substitute at the Osteotomy Site.
The goal of this study is to evaluate whether the use of a bone graft substitute at the osteotomy site will result in better stability and diminish early relapse after mandibular lengthening surgery.
The study focuses on the evaluation of the following hypothesis:
The use of bone graft substitute at the osteotomy site has an influence on:
- The 3-dimensional stability of the osteotomy site
- Early relapse based in the plasticity of the site
Read the detailed description
Bilateral sagittal split osteotomy (BSSO)of the mandible is a surgical procedure used to correct dentofacial discrepancies. Post-operative stability is of great concern for CMF (Cranio maxillo facial) surgeons as the goal is to achieve optimal functional outcomes, good aesthetic results and satisfaction of patients' concerns. Skeletal relapse is a known complication of mandibular lengthening surgery and is divided into two groups; short term or early relapse and long term or late relapse.
Short term relapse occurs within the first 6 to 8 weeks post-operatively and is due to intersegmental movement at the osteotomy site (osteotomy slippage) and osteosynthesis slippage. Late relapse is thought to be caused by progressive condylar resorption, a clinical entity affecting the temporomandibular joint.
The rationale to reconstruct the lateral cortical defect resulting from mandibular advancement with BSSO with a bone graft substitute lies in the prevention of an unaesthetic notching at the inferior border. The use of a self-hardening, space-occupying paste could add mechanical stability, thus increase 3D-stability at the osteotomy site and prevent early relapse.
The use of cone-beam computed tomography (CBCT) in the treatment planning and postoperative follow-up of orthognathic patients has provided the surgeons with a new three-dimensional imaging modality to evaluate the postoperative skeletal relapse and postoperative morphologic changes of the condyles. Skeletal relapse, as well as positional and dimensional changes of the condyles, can be quantified in three dimensions.
- Conditions
- Mandibular Hypoplasia, Relapse
- Being tested
- Bilateral sagittal split osteotomy
- Keywords
- hydroset
- Medical subject headings
- Micrognathism, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral sagittal split osteotomyProcedure or surgery
Bilateral sagittal split osteotomy of the mandible is a surgical procedure used to correct dentofacial discrepancies
| Study group | Role | What they receive |
|---|---|---|
| hydroset | patients receiving hydroset at osteotomy site Receives: Procedure: Bilateral sagittal split osteotomy | |
| Control | patients not receiving hydroset at osteotomy site Receives: Procedure: Bilateral sagittal split osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
early relapse by means of three dimensional color maps (CBCT)
evaluation at the osteotomy gap, the position of the condyles, rami and chin
Measured: the first 6 months postoperatively
Secondary outcomes (1)
condylar resorption by means of three dimensional color maps (CBCT)
a three-dimensional volumetric analysis of the condylar head and the glenoid cavity
Measured: the first 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start11 Sep 2018
- Primary completion1 Sep 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mandibular HypoplasiaStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veerle Van Mossevelde, Universitair Ziekenhuis Brussel
- Investigators
- Erica Coppey, MD, Principal investigator, Universitair Ziekenhuis BrusselMaurice Mommaerts, Prof. Mult, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03710512
- Sponsor's protocol ID
- EARLY RELAPSE AFTER MANDIBULAR
- Status last verified
- Oct 2018
- First submitted
- 28 Jun 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Relapse After Mandibular Lengthening Surgery With or Without the Use of a Bone Graft Substitute at the Osteotomy Site.
- ClinicalTrials.gov ID
- NCT03710512
- Acronym / sponsor ID
- EARLY RELAPSE AFTER MANDIBULAR
- Conditions
- Mandibular Hypoplasia, Relapse
- Keywords
- hydroset
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 18 Oct 2018 (actual)
- 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.
The goal of this study is to evaluate whether the use of a bone graft substitute at the osteotomy site will result in better stability and diminish early relapse after mandibular lengthening surgery.
The study focuses on the evaluation of the following hypothesis:
The use of bone graft substitute at the osteotomy site has an influence on:
- The 3-dimensional stability of the osteotomy site
- Early relapse based in the plasticity of the site
Detailed description
Bilateral sagittal split osteotomy (BSSO)of the mandible is a surgical procedure used to correct dentofacial discrepancies. Post-operative stability is of great concern for CMF (Cranio maxillo facial) surgeons as the goal is to achieve optimal functional outcomes, good aesthetic results and satisfaction of patients' concerns. Skeletal relapse is a known complication of mandibular lengthening surgery and is divided into two groups; short term or early relapse and long term or late relapse.
Short term relapse occurs within the first 6 to 8 weeks post-operatively and is due to intersegmental movement at the osteotomy site (osteotomy slippage) and osteosynthesis slippage. Late relapse is thought to be caused by progressive condylar resorption, a clinical entity affecting the temporomandibular joint.
The rationale to reconstruct the lateral cortical defect resulting from mandibular advancement with BSSO with a bone graft substitute lies in the prevention of an unaesthetic notching at the inferior border. The use of a self-hardening, space-occupying paste could add mechanical stability, thus increase 3D-stability at the osteotomy site and prevent early relapse.
The use of cone-beam computed tomography (CBCT) in the treatment planning and postoperative follow-up of orthognathic patients has provided the surgeons with a new three-dimensional imaging modality to evaluate the postoperative skeletal relapse and postoperative morphologic changes of the condyles. Skeletal relapse, as well as positional and dimensional changes of the condyles, can be quantified in three dimensions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydroset | – | Procedure: Bilateral sagittal split osteotomypatients receiving hydroset at osteotomy site |
| Control | – | Procedure: Bilateral sagittal split osteotomypatients not receiving hydroset at osteotomy site |
Who may qualify
- Ages
- 10 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Class II occlusion of non-syndromic origin, mandibular hypoplasia
Key inclusion criteria (3 listed)
- Class II occlusion of non-syndromic origin, mandibular hypoplasia
- Availability of pre- and postoperative CBCT scans of sufficient quality
- Age: >10years
Key exclusion criteria (4 listed)
- Previous orthognathic surgical treatment
- Simultaneously performed genioplasty
- Plate osteosynthesis
- Buccal plate fracture during surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral sagittal split osteotomyBilateral sagittal split osteotomy of the mandible is a surgical procedure used to correct dentofacial discrepancies | Procedure or surgery | Control, hydroset |
Primary outcome
early relapse by means of three dimensional color maps (CBCT)
Time frame: the first 6 months postoperatively
evaluation at the osteotomy gap, the position of the condyles, rami and chin
1 secondary outcome
condylar resorption by means of three dimensional color maps (CBCT)
Time frame: the first 6 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
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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.
Erica Coppey, MD principal investigator
Universitair Ziekenhuis Brussel
Maurice Mommaerts, Prof. Mult study director
Universitair Ziekenhuis Brussel
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 Mandibular Hypoplasia and Relapse, run by Universitair Ziekenhuis Brussel 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 4 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: status not confirmed, as of the sponsor's last update on 18 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Veerle Van Mossevelde, Datanurse (+32 2 476 31 34, veerle.vanmossevelde@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early relapse by means of three dimensional color maps (CBCT) (time frame: the first 6 months postoperatively). 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 Oct 2018.