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Completed

NCT Number: NCT02918344

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.

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Key information

Age range

15 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

universitair Ziekenhuis brussel

Jette, Brussels Capital, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hydroset

Other

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.

Standard sagittal split osteotomy

Procedure

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

Primary outcomes

  1. Surgical site infection

    Time frame: 6 months

    Determine the number of surgical site infection

Secondary outcomes

  1. Hardware removal

    Time frame: 6 months

    Determine the number of hardware removal

  2. Revision

    Time frame: 6 months

    Determine the number of revisions

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Sep 28, 2016
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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