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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02918344
• Other study ID #: Calciumfosfaat cement
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: April 2020

Study information

• Verified date: August 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: Veerle Van Mossevelde, Data Nurse
• Phone: +32 2 476 31 34
• Email: veerle.vanmossevele[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 192
• Est. completion date: April 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Infection
• Jaw Anomalies

Intervention

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.

Locations

Country	Name	City	State
Belgium	universitair Ziekenhuis brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical site infection	Determine the number of surgical site infection	6 months
Secondary	Hardware removal	Determine the number of hardware removal	6 months
Secondary	Revision	Determine the number of revisions	6 months