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

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Infection; Jaw Anomalies

Treatments: Procedure: Standard sagittal split osteotomy; Other: Hydroset

Study type: Observational

Funder types: Other

Identifiers

NCT02918344

Calciumfosfaat cement

Details and patient eligibility

About

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.

Full 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.

Enrollment: 196 patients

Sex: All

Ages: 15 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

196 participants in 2 patient groups

Standard sagittal split osteotomy group

Description:

Patients undergoing sagittal split osteotomy without paste application

Treatment:

Other: Hydroset

Procedure: Standard sagittal split osteotomy

Cohort/Hydroset group

Description:

Patients undergoing sagittal split osteotomy with paste application

Treatment:

Other: Hydroset

Procedure: Standard sagittal split osteotomy