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临床试验/NCT03407911
NCT03407911已完成不适用

Rating Comparative Microbiology of Cell Populations Present Around Teeth Affected by Periodontal Disease and Implants Affected by Peri-implant Disease.

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年2月1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
50
试验地点
1
主要终点
Peri-implant Microbiota

研究概览

简要总结

The purpose of the study was to evaluate, from a microbiological point of view, microbiota around teeth and implants in the same patient affected by periodontal disease and peri-implant disease, all compared with a healthy tooth. From the identification of particular bacterial species in the examined sites, it is intended to be traced back to the identification of a clear etiopathogenic process, which may shed light on the similarities and differences between the two diseases. In recognition of these mechanisms, the investigators think to develop new therapeutic strategies for the future.

详细描述

Harvested via sterile paper points, for endodontic use, the sulcular fluid present around a dental element affected by periodontitis, and, in the same patient, the fluid present inside a peri-implant sulcus of a implant affected periimplantitis. If more implants are considered affected by perimplantitis, partecipant will choose the worst as sample site. The same principle will be followed in the case of the tooth affected by periodontal disease. The samples must be underwent to bacterial genomic meta-analysis for the precise identification of bacterial. For a better comparation of the flora, even a healthy tooth from the same patient will be choose like test site and a gingival crevicular fluide will be harvested on it.

The investigators think that the perfect knowledge of the pathogen species is the starter point from a correct therapeutic strategy. But is really important take in mind the individual characteristcs of oral microflora.

The data to be noted at the outset are:

Signs and symptoms of periodontal disease, with precise framing within the Armitage 1999 Classification, and peri-implant disease. For the aim of the study definition of perimplantitis concern an implant with a 4 mm minimal probing depth with bleeding on probing and or suppuration (BOP and Supp) and radiographic bone loss (BL).

Evidence of BL recorded in order of definition of 8th European Consensus Conference of Periodontology Working group 4: BL > 2 mm from the expected bone level if a preliminary rx was absent; Rx 2-3 times the SD of the measurement record (1-1,5 mm) in case a preliminary rx was present.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

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

入选标准

  • Implant in service for at least one year without any technical GBR.
  • Only Implant inserted on native bone
  • Fill out a medical history form and a periodontal board dedicated to the event

排除标准

  • Post-extractive implant
  • Patients in subintrant systemic conditions that contraindicate the insertion of implants
  • Patients in the last three months have taken antibiotics or follow any therapy for the resolution of acute events.
  • Women who are pregnant or nursing or undergoing hormone therapies

结局指标

主要结局

Peri-implant Microbiota

时间窗: 1 day

bacterial population around implant affected by peri-implantitis

次要结局

  • Microbiota in Peri-implantitis and periodontal disease(1 day)

研究者

发起方
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Barbagallo

Professor

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

研究点 (1)

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