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临床试验/NCT03714295
NCT03714295已完成不适用

Impact of Interdental Brushing on the Evolution of Supra-gingival Bacterial Flora in Healthy Subjects Aged 18 to 35 Years (BACTERIB)

Claude Bernard University1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2015年4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
25
试验地点
1
主要终点
Enumeration of periodontal pathogens in interdental microbiota

研究概览

简要总结

In France, two-thirds of adults over 35 years of age have at least a periodontal disease. The etiology is the accumulation of dental plaque, especially in interdental spaces. The cleaning of interdental spaces is particularly complex. This accumulation of dental plaque is at the origin of a modification of the bacterial flora in favor of periodontopathogenic bacteria. These pathogens can induce within the periodontal tissues an immune and inflammatory reaction that cause tissue degradation. The majority of studies focus on people over 30 years of age with gingivitis or periodontitis. However, young adults, in whom the initial or even reversible stages of periodontal disease are the most frequent, should be the preferred target of preventive measures for this pathology.

The main objective of this study is to quantify, in healthy patients, the evolution of the supragingival bacterial flora, in the interdental spaces, following the daily passage of brushes with the adapted diameter and single passage. The secondary objective is to evaluate the qualitative change in the bacterial flora (proportions of periodontal bacteria / commensal bacteria) following the interdental cleaning.

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 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • having teeth at the 4 interdental sites studied (15-16, 25-26, 35-36, 45-46),
  • reporting a minimum of two daily toothbrushes,
  • having a good understanding of the French language,
  • accepting the terms of the study and signing written informed consent,
  • in good general health (opinion of the investigator) without significant clinical abnormality and medical history.

排除标准

  • Smoking patients (daily consumption greater than or equal to 1 cigarette),
  • patients with pathologies: diabetic, haemophilia, anticoagulant, platelet antiaggregant, pregnant and lactating women,
  • patients with a history of periodontal treatments,
  • patients with mandibular fixed orthodontic appliances and or maxillary, masticatory coefficient less than 80%,
  • patients who have taken antibiotics in the past 3 months,
  • patients using interdental brushes on a regular basis (more than once a week) in addition to brushing teeth or mouthwash ,
  • patients at risk for infectious endocarditis,
  • patients unable to answer questions,
  • non-cooperative patients,
  • patients requiring geographic mobility compromising evaluation.

结局指标

主要结局

Enumeration of periodontal pathogens in interdental microbiota

时间窗: 3 months

Quantitative RT-PCR analyses for A. viscosus, S.mitis, Streptococcus sp., V. parvula, A. odontolyticus, E. corrodens, C. sputigena, C. ochracea, C. concisus, A. actino a, A. actino b, S. sobrinus.- et des bactéries pardonthopathogènes - C. gracilis, C. rectus, P. intermedia, P. nigrescens, P. micros, F. nuc, P. gingivalis, T. forsythensis, T. denticola, S. mutans, and Lactobacillus spp. in the interdental microbiota.

次要结局

  • Enumeration of periodontal pathogens in interdental microbiota of young adults using or not interdental brushes by real-time PCR(3 months)

研究者

发起方
Claude Bernard University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Denis Bourgeois

Sponsor

Claude Bernard University

研究点 (1)

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