Effect of Probiotic on the Plaque pH. A Randomized Double Blind Interventional Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Lower plaque acidogenicity
研究概览
简要总结
The aim of the present research protocol was to evaluate the effect of probiotics daily used, on the plaque acidogenicity of children. The null hypothesis was that the plaque acidogenicity would remain unchanged and not associate with the use of probiotics. Moreover, the in situ study will be carried out to investigate the plaque formation as biofilm in demineralised enamel specimens following the regular consumption of a probiotic product compared to a control group. Metabolic of the biofilm formed on of the enamel specimens resulting from the consumption will be evaluated over a period of 8 weeks.
详细描述
Prior to the start of the study, demographic, ethnic and prognostic data will be collected (screening phase). A medical history will be taken, with documentation of previous and concomitant treatment and a clinical examination of the oral cavity (dental status, oral mucosa) will be performed by the investigator. If the test subject meets all the inclusion criteria without fulfilling any of the exclusion criteria, he/she will be enrolled in the clinical trial and given a test subject identification number.
All test subjects will receive a patient diary in the screening phase.
Washout phase I (1 week):
The test subjects will use only the fluoride-containing toothpaste provided by the sponsor for daily oral hygiene. A soft toothbrush will likewise be provided.
The test subjects will also receive a patient diary which will inform them that during the treatment phase they may not use any fluoride containing oral hygiene products (tooth-paste, mouthwashes, gels etc.) other than the study tooth-paste, drink any fluoride-containing mineral water or black tea, or eat any fish meals.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written declaration of informed consent signed by parents/guardian
- •At least 20 teeth
- •Good general health, as assessed by investigator
- •Average oral hygiene (cleaning the teeth at least twice a day)
- •Agreement of test subject not to use any oral hygiene products other than the test products and toothpaste provided for the duration of the study; the use of non-fluoridated oral hygiene agents is allowed.
- •Flow rate of stimulated saliva ≥ 0.7 ml/min
- •At least on caries active lesion (d/D>0)
排除标准
- •Ongoing oral or dental treatment except for emergency treatment.
- •Known allergic reaction to an oral hygiene product and/or medication and/or dental material previously used in the mouth or pharynx.
- •Existing allergy to one of the components of the test products or the standard toothpaste.
- •Pathological changes of the oral mucosa, e.g. acute ulcerating gingivitis, acute herpetic gingivostomatitis, recurrent aphthous ulceration or systemic illnesses with oral manifestations.
- •Use of fluoride-containing products (pastes, mouthrinses) within the 14 days prior to the introduction of the intra-oral appliances.
- •Use of fluoride-containing products: gels, tablets, varnishes, fillings etc. or of erosive broncholytics or antiasthmatics within 30 days prior to the introduction of the intra-oral specimen holder.
- •Antibiotic therapy within the past six months.
- •Any non-permitted therapy.
结局指标
主要结局
Lower plaque acidogenicity
时间窗: 2 months
The regular consumption of probiotic will lead to a significantly lower plaque acidogenicity compared to a placebo. Regular oral hygiene is permitted.
次要结局
未报告次要终点
研究者
Guglielmo Campus
Associate Professor of Community Dentistry
Università degli Studi di Sassari