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临床试验/NCT04982302
NCT04982302已完成不适用

Evaluation of Salivary and Intestinal Microbiological Response in Patients With Stage III-IV Periodontitis After Non-surgical Periodontal Therapy

University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2021年5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
94
试验地点
1
主要终点
Changes in microbiome alpha diversity measured from stool samples at 3 months

研究概览

简要总结

Periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. The long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. The present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. Fifty patients affected by stage III-IV periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. Salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. Age, gender and BMI-matched healthy individuals will be recruited as controls.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • periodontitis Stage III or IV
  • BMI between 20 and 29 kg/m2
  • free diet
  • presence of at least 20 teeth

排除标准

  • systemic diseases (including diabetes, thyroid, liver, or kidney diseases)
  • dietary allergies
  • use of antibiotics or probiotics during the previous 30 days
  • pregnancy or breast feeding

结局指标

主要结局

Changes in microbiome alpha diversity measured from stool samples at 3 months

时间窗: [Time Frame: Baseline and 90 days]

Taxonomic and functional variation of gut bacteria after treatment

次要结局

  • Changes in microbiome alpha diversity measured from saliva samples at 3 months([Time Frame: Baseline and 90 days])
  • Changes in mean clinical attachment level (CAL) at 3 months([Time Frame: Baseline and 90 days])
  • Changes in periodontal pocket depth (PPD) at 3 months([Time Frame: Baseline and 90 days])
  • Changes in full mouth bleeding score (FMBS) at 3 months([Time Frame: Baseline and 90 days])

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Sponsor

研究点 (1)

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