universitair Ziekenhuis brussel
Jette, Brussels Capital, 1090, Belgium
NCT Number: NCT02918344
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.
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Notify Me15 year–75 year
All sexes
Observational
Jette, Brussels Capital, 1090, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.
Time frame: 6 months
Determine the number of surgical site infection
Time frame: 6 months
Determine the number of hardware removal
Time frame: 6 months
Determine the number of revisions
Universitair Ziekenhuis Brussel
Other
Prospective Study: Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies
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