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