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

• Conditions: Jaw Anomalies; Infection
• Interventions: Other: Hydroset; Procedure: Standard sagittal split osteotomy

• Registration Number: NCT02918344
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Study Start: 2017-03-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28
• Primary Completion: 2019-12
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort/Hydroset group	Hydroset	Patients undergoing sagittal split osteotomy with paste application
Standard sagittal split osteotomy group	Standard sagittal split osteotomy	Patients undergoing sagittal split osteotomy without paste application
Cohort/Hydroset group	Standard sagittal split osteotomy	Patients undergoing sagittal split osteotomy with paste application
Standard sagittal split osteotomy group	Hydroset	Patients undergoing sagittal split osteotomy without paste application

Primary Outcome Measures

Name	Time	Method
Surgical site infection	6 months	Determine the number of surgical site infection

Secondary Outcome Measures

Name	Time	Method
Hardware removal	6 months	Determine the number of hardware removal
Revision	6 months	Determine the number of revisions

Trial Locations

Locations (1)

universitair Ziekenhuis brussel; 🇧🇪 Jette, Brussels, Belgium