Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies
NCT ID: NCT02918344
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
196 participants
OBSERVATIONAL
2017-03-01
2020-04-30
Brief Summary
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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
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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
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Standard sagittal split osteotomy group
Patients undergoing sagittal split osteotomy without paste application
Hydroset
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 osteotomy
The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.
Cohort/Hydroset group
Patients undergoing sagittal split osteotomy with paste application
Hydroset
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 osteotomy
The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.
Interventions
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Hydroset
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 osteotomy
The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.
Eligibility Criteria
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Inclusion Criteria
* Gender: M/F
* Age: \>15y-75y
Exclusion Criteria
* Congenital facial malformations
* Unilateral SSO
* Immunodeficiency
* Simultaneous removal of lower third molars
* Incomplete postoperative follow-up
15 Years
75 Years
ALL
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Erica Coppey, Dr.
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Maurice Mommaerts, Prof.Dr.Mult
Role: STUDY_DIRECTOR
Universitair Ziekenhuis Brussel
Locations
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universitair Ziekenhuis brussel
Jette, Brussels Capital, Belgium
Countries
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Other Identifiers
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Calciumfosfaat cement
Identifier Type: -
Identifier Source: org_study_id