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临床试验/NCT01256996
NCT01256996Unknown2 期

A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder

Heidelberg University0 个研究点目标入组 40 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
2 期
入组人数
40
主要终点
Pocket probing depth

研究概览

简要总结

In the last decade, the number of dental implantations continuously increases. However, at the same time, the prevalence of peri-implantitis increases, too. Although both surgical and non-surgical interventions are available for the therapy, there is no efficient and satisfying therapy option resulting in an adequate improvement of this disease.

An innovative, low abrasive powder has been introduced for the therapy of periodontitis. However, the powder might be suitable for the peri-implantitis therapy, also, and could improve the effectiveness of the therapy. The usage of this powder in peri-implantitis patients has not been assessed in a clinical trial although the effectiveness in natural teeth has been demonstrated.

The aim of this prospective, randomised, multi-centre trial is to assess the effectiveness of the aforementioned powder in peri-implantitis patients.

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
Single (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

  • Mild to moderate peri-implantitis
  • age ≥18 years
  • capacity to contract
  • no subgingival debridement within the last six months
  • informed consent

排除标准

  • pregnancy
  • subgingival debridement within the last six months
  • bleeding tendency
  • usage of antibiotics within the last three months
  • insufficient restorations (including caries etc.)
  • Diabetes mellitus
  • implantats with platform switch

结局指标

主要结局

Pocket probing depth

时间窗: Twelve months

次要结局

  • Assessment of pain levels(One week and six months)
  • Assessment of the oral health related quality of life using the OHIP (14)(One , three, six and twelve months)

研究者

申办方类型
Other

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