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

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.

Study Overview

• Status: Completed
• Conditions: Infection; Jaw Anomalies
• Intervention / Treatment: Other: Hydroset; Procedure: Standard sagittal split osteotomy

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 Type: Observational
• Enrollment (Actual): 196

Contacts and Locations

Study Locations

• Belgium
  • Brussels Capital
    • Jette, Brussels Capital, Belgium, 1090
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing bilateral sagittal split osteotomy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard sagittal split osteotomy group; Patients undergoing sagittal split osteotomy without paste application	Other: 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.; Procedure: 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	Other: 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.; Procedure: Standard sagittal split osteotomy; The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection	Determine the number of surgical site infection	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hardware removal	Determine the number of hardware removal	6 months
Revision	Determine the number of revisions	6 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Erica Coppey, Dr., Universitair Ziekenhuis Brussel; Study Director: Maurice Mommaerts, Prof.Dr.Mult, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: September 27, 2016
• First Posted (Estimated): September 28, 2016

Study Record Updates

• Last Update Posted (Estimated): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: calcium phosphate paste
• Additional Relevant MeSH Terms: Infections
• Other Study ID Numbers: Calciumfosfaat cement

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO