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Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies

Prospective Study: Complications From the Use of Calcium Phosphate Paste in Mandibular Lengthening Osteotomies

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02918344
Enrollment
196
Registered
2016-09-28
Start date
2017-03-01
Completion date
2020-04-30
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection, Jaw Anomalies

Keywords

calcium phosphate paste

Brief 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. 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.

Interventions

OTHERHydroset

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.

PROCEDUREStandard sagittal split osteotomy

The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* All patients with dysgnatic deformities requiring mandibular lengthening surgery * Gender: M/F * Age: \>15y-75y

Exclusion criteria

* Previous orthognathic surgery * Congenital facial malformations * Unilateral SSO * Immunodeficiency * Simultaneous removal of lower third molars * Incomplete postoperative follow-up

Design outcomes

Primary

MeasureTime frameDescription
Surgical site infection6 monthsDetermine the number of surgical site infection

Secondary

MeasureTime frameDescription
Hardware removal6 monthsDetermine the number of hardware removal
Revision6 monthsDetermine the number of revisions

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026