NCT03554187已完成不适用
Efficacy of Supplementation With Probiotics as Adjuvant to Mechanical Treatment in Chronic Periodontitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PiLeJe
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Mean level of clinical attachment (CAL)
研究概览
简要总结
It aims to demonstrate the superiority of a 6-week supplementation with Lactibiane Buccodental compared to placebo, as adjunctive therapy in chronic periodontitis in patients with generalized chronic periodontitis
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with acute oral lesions or necrotizing ulcerative periodontitis;
- •Patient who has taken antibiotics in the last 3 months, or who has received treatment affecting periodontal tissue in the past month, or on immunosuppressive therapy (ciclosporin), antihypertensive (nyfedipine), antiepileptic (phenytoin), under biotherapy, or under treatment of hyposialie;
- •Patient with a medical history or current pathology that, in the opinion of the investigator, is likely to interfere with the results of the study or to expose him / her to additional risk: unbalanced diabetes, rheumatic fever, disease affecting renal or hepatic function, neurological deficiency, immunological disease;
- •Patient smoking more than 10 cigarettes a day;
- •Patient with known allergy to at least one of Lactibiane Buccodental® ingredients;
- •Pregnant or breastfeeding woman or intending to start a pregnancy within 3 months;
- •a woman who is in a state of childbearing not covered by an active method of contraception;
- •Patient with a psychological or linguistic disability to understand and sign informed consent, or to understand and implement the constraints of the study;
- •Patient participating in another clinical trial, or at the time of exclusion from another clinical trial;
- •Patient under legal protection (tutorship, guardianship) or deprived of his rights following the administrative or judicial decision.
- •Patient not affiliated to a social security scheme
排除标准
- 未提供
结局指标
主要结局
Mean level of clinical attachment (CAL)
时间窗: up to 3 months
Clinical Attachment (CAL) of parondontal pocket ; measurement with Florida Probe in millimeters
次要结局
- Quantitative evolution of Prevotella intermedia (Pi) bacteria(day -14, day 1, day 45, day 90)
- Evolution of several oral indices : Pocket depth(day -14, day 1, day 45, day 90)
- Evaluate adherence to treatment(up to a year)
- Quantitative evolution of Tannerella forsythia (Tf) bacteria(day -14, day 1, day 45, day 90)
- Quantitative evolution of Aggregatibacter actinomycetemcomitans (Aa) bacteria(day -14, day 1, day 45, day 90)
- Quantitative evolution of Fusobacterium nucleatum (Fn) bacteria(day -14, day 1, day 45, day 90)
- Evolution of halitosis(day -14, day 1, day 45, day 90)
- Quantitative evolution of Porphyromonas gingivalis (Pg) bacteria(day -14, day 1, day 45, day 90)
- Evolution of several oral indices : Gingival bleeding on probing(day -14, day 1, day 45, day 90)
- Quantitative evolution of Treponema denticola (Td) bacteria(day -14, day 1, day 45, day 90)
- Safety (tolerance to treatment)(up to a year)
- Evolution of several oral indices : Gingival recession(day -14, day 1, day 45, day 90)
- Overall clinical course of periodontitis(day -14, day 1, day 45, day 90)
研究者
研究点 (4)
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