Probiotics That Moderate pH and Antagonize Pathogens to Promote Oral Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2
研究概览
简要总结
This study will examine the mechanisms of action of probiotics and synbiotics for control of oral diseases, with a particular focus on exploring new strategies for caries prevention and treatment.
详细描述
Subjects recruited in years 1, 2, and 4 will only be seen for one study visit and will follow the research visit protocol listed below:
Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked to fill out a study registration form and an oral habits/medical history form. They will be asked to sign an Informed Consent. The subject will then have their teeth and gums examined. At this visit, the investigator will assess whether or not the subject is a good candidate for the study. During the phone interview each subject was asked not to brush or floss their teeth and not to eat or drink anything other than water for 8 hours prior to the pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline). If not, they will be asked to return to the clinic for another visit and asked not to brush or floss their teeth and not to eat or drink anything other than water 8 hours prior to that appointment. This visit will then be consider Visit 1 (Baseline).
Visit 1 (Baseline) - The subject will have their medical and dental history reviewed. They will have their teeth and gums examined. Saliva and plaque will be collected. This will be the end of the study for subjects recruited in years 1, 2, and 4.
Subjects will be grouped by the year they participate in the study. Subjects recruited in year 3 will follow the research visit protocol outlined below:
Pre-Screening - If the subject chooses to be pre-screened for this study they will be asked to fill out a study registration form and an oral habits/medical history form. They will be asked to sign an Informed Consent. The subject will then have their teeth and gums examined. At this visit, the investigator will assess whether or not the subject is a good candidate for the study. During the phone interview each subject was asked not to brush or floss their teeth and not to eat or drink anything other than water for 8 hours prior to the pre-screening visit (Visit 0). If the subject was compliant with these requests, oral samples will be collected at this pre-screening visit and will now be considered Visit 1 (Baseline). If not, they will be asked to return to the clinic for another visit and asked not to brush or floss their teeth and not to eat or drink anything other than water 8 hours prior to that appointment. This visit will then be considered Visit 1 (Baseline).
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)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Twenty natural uncrowned teeth excluding third molars
- •No contraindications to dental treatment
- •Caries Free-(with no clinical evidence of past or present caries)
- •Caries Active- (At least two active sites)
排除标准
- •Less than 20 teeth
- •Systemic disease that can cause xerostomia
- •Taking medication known to cause xerostomia
- •Have been treated with antibiotics within the past 3 months
- •Advanced periodontal disease
- •Removable or fixed dental appliances
- •Bleeding disorders or taking anticoagulant medications
- •Immune compromised individuals
- •Uses tobacco products
- •Participation in another clinical study one week prior to the start of the washout period or during the study period
- •Use of any flavored products, such as mint flavored candies and chewing gum, one week prior to or during the study
- •Unwilling or unable to provide informed consent and follow plaque/saliva collection instructions
结局指标
主要结局
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 2
时间窗: Changes from baseline to 2 weeks (Screening)
Saliva and dental plaque will be collected during the baseline and week 2 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 8 to week 12
时间窗: Changes from week 8 to week 12 (Evaluation)
Saliva and dental plaque will be collected during the week 8 and week 12 visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from baseline to week 12.
时间窗: Changes from baseline to week 12 (Evaluation)
Saliva and dental plaque will be collected during the baseline and week 12 study visits. The amount of ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 2 to week 4
时间窗: Changes from week 2 to week 4 (Baseline)
Saliva and dental plaque will be collected during the week 2 and week 4 study visits. The amount of citrulline and/or ammonia produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
Levels of the arginine deiminase system (ADS) in oral samples of healthy and caries-active subjects changes from week 4 to week 8
时间窗: Changes from week 4 to week 8 (Washout)
Saliva and dental plaque will be collected during the week 4 and week 8 study visits. The amount of ammonia and/or citrulline produced via the ADS by oral bacteria present in the collected oral samples will be measured and compared using standardized protocols.
次要结局
- Bacteria collected from oral samples of healthy and caries-active subjects changes from week 4 to week 8(Changes from week 4 to week 8)
- Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 2(Changes from baseline to week 2)
- Bacteria collected from oral samples of healthy and caries-active subjects changes from week 2 to week 4(Changes from week 2 to week 4)
- Bacteria collected from oral samples of healthy and caries-active subjects changes from week 8 to week 12(Changes from week 8 to week 12)
- Bacteria collected from oral samples of healthy and caries-active subjects changes from baseline to week 12(Changes from baseline to week 12)