In Vivo Evaluation of Antibacterial Toothpaste Efficiency and Patients' Satisfaction: a Double-blind Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Bacterial Count of Streptococcus Mutans (S. Mutans)
研究概览
简要总结
The primary objective of this randomized controlled clinical trial (RCCT) will be to compare the efficacy in reducing the quantity of Streptococcus mutans (S. Mutans) in saliva of a recently introduced toothpaste compared to a commercially available toothpaste. The secondary outcomes will be to assess patients' impression of the toothpastes (in terms of taste, satisfaction etc.), and to investigate potential changes in dentin hypersensitivity, plaque formation and gingival inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with minimum 20 teeth;
- •Good oral hygiene level (gingival bleeding index not exceeding 20%)
- •Patients willing to participate in the study and able to sign an informed consent
排除标准
- •Tooth anomalies (amelogenesis imperfecta, dentinogenesis imperfecta etc.);
- •Intrinsic stain (fluorosis);
- •Caries lesions;
- •Advanced periodontal disease (probing >2, spontaneous gum bleeding, tooth mobility >1);
- •Use of orthodontic devices;
- •Use of antibiotics in the last 3 months;
- •Use of antibacterial mouth rinses in the last 3 months;
- •Potential allergies;
- •Drug and alcohol abuse;
结局指标
主要结局
Bacterial Count of Streptococcus Mutans (S. Mutans)
时间窗: 4 weeks
Agar Mitis salivarius with tellurium and bacitracin (MSTB) will be used for S. mutans isolation. The 0.1 ml saliva sample will be diluted with 0.9 ml of sterile normal saline; next, decimal dilutions of saliva will be made up to 10-3. Each medium plate will be cultured from 0.1 ml of the previously diluted sample to 10-3; then, the sample will be uniformly spread on the agar plates. Finally, the plates will be sealed. They will be incubated for 48 hours at 37°C. The bacterial colonies will be observed under a stereo microscope and identified by morphology and color. The CFU will be multiplied by the number of times the sample was originally diluted and expressed as the number of colony forming units per millilitre (CFU/mL) of saliva.
次要结局
- Plaque Index(4 weeks)
- Gingival Index(4 weeks)
- Dentin Hypersensitivity(4 weeks)
- Tooth Colour(4 weeks)
研究者
Lorenzo Breschi
Professor
University of Bologna