Jaw AnomaliesNCT02918344
Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies
An observational study of Jaw Anomalies and Infection, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The goal of this study is to determine if the use of calcium phosphate paste in mandibular lengthening surgery causes more complications as surgical site infections and hardware removal. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Jaw Anomalies, Infection
- What is being tested?
- Hydroset and Standard sagittal split osteotomy
- Type of treatment
- Surgery or procedure
- How many people
- 196 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2017to 30 Apr 2020
- 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing bilateral sagittal split osteotomy
Who may be able to join
- All patients with dysgnatic deformities requiring mandibular lengthening surgery
- Gender: M/F
- Age: >15y-75y
Who cannot join
- Previous orthognathic surgery
- Congenital facial malformations
- Unilateral SSO
- Immunodeficiency
- Simultaneous removal of lower third molars
- Incomplete postoperative follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study: Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies
The goal of this study is to determine if the use of calcium phosphate paste in mandibular lengthening surgery causes more complications as surgical site infections and hardware removal.
An evaluation will be made to determine if the benefits of the use of the paste (3D-stability, prevention of early relapse and unaesthetic indentation) outweighs the disadvantages.
Read the detailed description
The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies. Correction of distocclusion can be achieved through lengthening of the mandible, and a balanced facial appearance can be obtained by increasing chin projection.
Calcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border(1)(2) and to help stabilize the segments when osteosynthesis slippage is feared for. A recently performed retrospective study showed an increase of infectious complications when calcium phosphate paste was used for this indications. Several precautions were identified that could be undertaken to decrease the infectious complications. The study concluded that a prospective study was required in which these precautions were implemented to determine whether infectious complications can be reduced.
The aim of this study is to investigate whether the hardened paste still increases the incidence of site infections after implementation of several precautions and the use of a standardized antibiotic prophylactic protocol.
- Conditions
- Jaw Anomalies, Infection
- Being tested
- Hydroset, Standard sagittal split osteotomy
- Keywords
- calcium phosphate paste
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrosetOther
Calcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border and to help stabilize the segments when osteosynthesis slippage is feared for.
Standard sagittal split osteotomyProcedure or surgery
The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.
| Study group | Role | What they receive |
|---|---|---|
| Standard sagittal split osteotomy group | Patients undergoing sagittal split osteotomy without paste application Receives: Other: Hydroset; Procedure: Standard sagittal split osteotomy | |
| Cohort/Hydroset group | Patients undergoing sagittal split osteotomy with paste application Receives: Other: Hydroset; Procedure: Standard sagittal split osteotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical site infection
Determine the number of surgical site infection
Measured: 6 months
Secondary outcomes (2)
Hardware removal
Determine the number of hardware removal
Measured: 6 months
Revision
Determine the number of revisions
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start1 Mar 2017
- Primary completion31 Dec 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw AnomaliesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erica Coppey, Dr., Principal investigator, Universitair Ziekenhuis BrusselMaurice Mommaerts, Prof.Dr.Mult, Study director, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02918344
- Sponsor's protocol ID
- Calciumfosfaat cement
- Status last verified
- Dec 2025
- First submitted
- 27 Sep 2016
- Last updated
- 18 Dec 2025
- 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 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study: Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies
- ClinicalTrials.gov ID
- NCT02918344
- Acronym / sponsor ID
- Calciumfosfaat cement
- Conditions
- Jaw Anomalies, Infection
- Keywords
- calcium phosphate paste
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 28 Sep 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.
The goal of this study is to determine if the use of calcium phosphate paste in mandibular lengthening surgery causes more complications as surgical site infections and hardware removal.
An evaluation will be made to determine if the benefits of the use of the paste (3D-stability, prevention of early relapse and unaesthetic indentation) outweighs the disadvantages.
Detailed description
The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies. Correction of distocclusion can be achieved through lengthening of the mandible, and a balanced facial appearance can be obtained by increasing chin projection.
Calcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border(1)(2) and to help stabilize the segments when osteosynthesis slippage is feared for. A recently performed retrospective study showed an increase of infectious complications when calcium phosphate paste was used for this indications. Several precautions were identified that could be undertaken to decrease the infectious complications. The study concluded that a prospective study was required in which these precautions were implemented to determine whether infectious complications can be reduced.
The aim of this study is to investigate whether the hardened paste still increases the incidence of site infections after implementation of several precautions and the use of a standardized antibiotic prophylactic protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard sagittal split osteotomy group | – | Other: Hydroset, Procedure: Standard sagittal split osteotomyPatients undergoing sagittal split osteotomy without paste application |
| Cohort/Hydroset group | – | Other: Hydroset, Procedure: Standard sagittal split osteotomyPatients undergoing sagittal split osteotomy with paste application |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing bilateral sagittal split osteotomy
Key inclusion criteria (3 listed)
- All patients with dysgnatic deformities requiring mandibular lengthening surgery
- Gender: M/F
- Age: >15y-75y
Key exclusion criteria (6 listed)
- Previous orthognathic surgery
- Congenital facial malformations
- Unilateral SSO
- Immunodeficiency
- Simultaneous removal of lower third molars
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 |
|---|---|---|
| HydrosetCalcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border and to help stabilize the segments when osteosynthesis slippage is feared for. | Other | Cohort/Hydroset group, Standard sagittal split osteotomy group |
| Standard sagittal split osteotomyThe sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies. | Procedure or surgery | Cohort/Hydroset group, Standard sagittal split osteotomy group |
Primary outcome
Surgical site infection
Time frame: 6 months
Determine the number of surgical site infection
2 secondary outcomes
Hardware removal
Time frame: 6 months
Revision
Time frame: 6 months
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 Dec 2025.
- 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.
Erica Coppey, Dr. principal investigator
Universitair Ziekenhuis Brussel
Maurice Mommaerts, Prof.Dr.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 Jaw Anomalies and Infection, 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 6 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 Dec 2025. 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?
Surgical site infection (time frame: 6 months). 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 Dec 2025.