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临床试验/NCT02918344
NCT02918344已完成不适用

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

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2017年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
196
试验地点
1
主要终点
Surgical site infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with dysgnatic deformities requiring mandibular lengthening surgery
  • Gender: M/F
  • Age: >15y-75y

排除标准

  • Previous orthognathic surgery
  • Congenital facial malformations
  • Unilateral SSO
  • Immunodeficiency
  • Simultaneous removal of lower third molars
  • Incomplete postoperative follow-up

结局指标

主要结局

Surgical site infection

时间窗: 6 months

Determine the number of surgical site infection

次要结局

  • Revision(6 months)
  • Hardware removal(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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