Effect of Drops Containing Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659) on Plaque Acidogenicity and Other Caries Related Variables in Orthodontic Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.
研究概览
简要总结
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients. Shortage on testing the effect of probiotic on Orthodontic patients can be seen on litterateurs making a gap of whether is product of help in preventing dental caries or not ?
详细描述
To investigate the short term effect of probiotic oil on plaque acidogenicity among orthodontic patients and to investigate the effect of probiotics on mutan streptococci and lactobacilli in plaque and saliva.
The null-hypothesis is that: The effect of probiotics would not differ from placebo-treated control group.
This product might decrease the chance of getting caries but also cooperation and cost effectiveness should be considered
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, Investigator)
盲法说明
3rd party will be involved in labeling the test and placebo samples
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects undergoing bimaxillary fixed orthodontic treatment
- •Number of S. mutans counts (>10.000 CFU/ml)
- •Permanent dentition
- •3-12 months into the treatment (study from Sweden by Andrea)
- •Medically healthy
- •Not taking any medication
- •Ability to understand the nature of the study and sign the consent form
排除标准
- •Cleft lip and palate patients as well as handicapped and patients with mental impairments
- •Systemic diseases or conditions that could interfere with our study (diabetes, immunosuppression diseases, pregnancy or ongoing therapy).
- •History of probiotics/anti-inflammatory drugs taken during the last 4 weeks prior to baseline examination
- •Local or general antimicrobial substances taken during the last 4 prior weeks prior to baseline examination
- •Habitual consumers of xylitol chewing gums
- •No active or untreated carious lesions and reported daily tooth brushing habit using fluoridated toothpaste
结局指标
主要结局
Effect of Probiotic oil (drops) on plaque acidogenicity (pH) among orthodontic patients.
时间窗: 3 weeks
Changes in the plaque pH (acidic or alkaline) is an important factor among others in the cares process, in which an acidic environment will help the bacteria to accumulate along the tooth surface and starting the caries lesions. So, considering the plaque pH as a clinical variable to show the probiotic effect is considered to be of great value.
次要结局
- Effect of Probiotics on Saliva(3 weeks)
- Effect of Probiotics on Dental plaque(3 weeks)