跳至主要内容
临床试验/NCT05282667
NCT05282667已完成不适用

Significance of Barrier Membrane in the Reconstructive Management of Peri-implantitis: A RCT

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2019年3月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
38
试验地点
2
主要终点
Changes in clinical parameters

研究概览

简要总结

With the growing burden of peri-implantitis around the globe, interest has flourished on the management of this pathology. Nevertheless, lack of consensus exists in the pursuit of a predictable therapy. Different therapeutic modalities have been advocated. Non-surgical therapy as a sole modality is often insufficient to resolve inflammation. Surgical interventions have demonstrated more favorable outcomes. Amongst these, evidence supported the application of resective, reconstructive, or combined approaches to limit progressive bone loss and achieve soft tissue health. Nevertheless, up to date, the most suitable modality remains unknown and the decision-making process derives from the understanding acquired from the management of periodontitis.

One critical element regarded to successfully resolve peri-implantitis is to efficiently detoxify the contaminated implant surface. Mechanical, pharmacological and chemical strategies have been proposed to eliminate bacterial plaque and remnants from the implant surface. However, evidence has not demonstrated superiority of a given detoxification agent/strategy.

In this sense, the significance of barrier membranes is not yet well understood. Roos-Jansaker in 2014 showed that the additional use of barrier membranes did not improve the outcome. Nevertheless, since then this subject has not been a matter of research.

详细描述

The effect of barrier membrane in the reconstructive management of peri-implantitis will be tested at 12-month follow-up

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-smokers
  • No use of antibiotics recently
  • No metabolic disorder
  • Infra-osseous or combined peri-implantitis defect

排除标准

  • Metabolic disorders that affect bone healing
  • Supra-crestal defects

结局指标

主要结局

Changes in clinical parameters

时间窗: 12 months

Number of patients where the disease was resolved. At implant level the changes in bleeding on probing and changes in probing pocket depths will be recorded as well

次要结局

  • Changes in Bone level(12-month follow-up)

研究者

发起方
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Reconstructive Management of Peri-implantitis | 临床试验