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临床试验/NCT04251650
NCT04251650Unknown不适用

Search for a Microbiotic Signature Associated With Periodontitis According to the Chicago Classification 2018

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
1
主要终点
Microbiota analysis of subgingival plaque

研究概览

简要总结

A new classification of periodontal diseases was created in 2018. the investigators want to know if this clinical classification is based, or not, on a biological reality. To do this, the investigators will collect data from the clinical examination (clinical assessment and radiological assessment) as well as non-invasive samples of subgingival plaque and crevicular gingival fluid (CGF). The subgingival plaque samples will be analyzed to define the microbiotic profiles of the patients and the CGF determined to define their inflammatory expression profiles. These results will then be linked to the diagnosis of severity of periodontitis.

详细描述

In the new classification of periodontal disease, the investigators will seek to know whether there is a specific bacterial signature associated with the severity of damage on the one hand, and the other hand, the investigators will search for cytokinic biomarkers which can be correlated with the severity of the damage.

In this study, the investigators propose to include 25 patients with periodontitis stage I and II versus stage III and IV according to Chicago classification (2018)

研究设计

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

入排标准

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

入选标准

  • Men and women speaking and understanding French
  • Aged over 18
  • with generalized periodontitis (more than 30% of affected sites)
  • Requiring non-surgical periodontal therapy
  • with a minimum of 12 teeth (3 per quadrant), fitted or not
  • Having given his oral consent to participate in the study
  • Having given his written consent to participate in a biocollection

排除标准

  • Less than 12 teeth present (3 teeth per quadrant)
  • Presence of acute oral lesions (periodontal abscesses, endodontic abscesses, infectious or mycotic lesions...)
  • Presence of ulcerative-necrotic gingivitis or periodontitis
  • Presence of endo-periodontal lesions
  • Chronic or systemic pathology or treatment that can influence the periodontal microbiota : immunotherapy, corticosteroid therapy, biotherapy, unbalanced diabetes, acute inflammatory rheumatism, neurological impairment...
  • Antibiotic during the 3 month preceding inclusion
  • Psychological or linguistic disability preventing good understanding of the study
  • Major patients under legal protection
  • Patients deprived of their liberty
  • Pregnant or lactating woman
  • Patient not affiliated to a health insurance scheme

结局指标

主要结局

Microbiota analysis of subgingival plaque

时间窗: through study completion, an average of 1 year

sample analysis by microbiome sequencing with 16S technics of subgingival plaque of affected sites and healthy sites

次要结局

  • Cytokinic concentrations in CGF(through study completion, an average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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