Investigation of the Interplay Between Local Oral Inflammation, Microbiota and Systemic Immune Responses.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Gingival Bleeding Index described by Ainamo & Bay, 1976
研究概览
简要总结
This is a clinical research study designed to measure changes in inflammation and the oral microbiome during a phase of good oral hygiene and the absence of oral hygiene. The goal of the study is to investigate the interplay between local oral inflammation, microbiota and systemic immune responses.
详细描述
An experimental gingivitis model will be used to explore changes in inflammation and the oral microbiome during gingivitis induction and resolution phases. Following consenting, screening, and enrollment, a dental intraoral (IO) scan or "digital impression" will be taken of the maxillary arch of each subject for the construction of an individual 3D printed tooth shield stent for use during the trial period. The customized stent (made of FDA approved resin material) will be used only on the experimental quadrant, and only during tooth brushing to prevent oral hygiene. Biological samples (blood, mucosal swabs, plaque biofilm, saliva, and gingival crevicular fluid) will be collected at each visit (pre-30 days, Baseline (Day 0), Day 3, Day 7, Day 14, Day 21, and Day 28. Plaque and gingivitis examinations will be taken at each visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Males and females, between 18-65 years of age;
- •Availability for the duration of the study;
- •ASA 1 Good general health (absence of any self-reported systemic disease or condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
- •Willingness to provide information related to their medical history;
- •Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
- •Informed Consent Form signed.
排除标准
- •Subjects with more that 2 sites with pocket depth of > 4 mm and those presenting purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone;
- •Oral pathology or a history of allergy to testing products;
- •Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner;
- •Subject participating in any other clinical study;
- •Subject pregnant or breastfeeding;
- •Subject allergic to oral care products and personal care consumer products
- •Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
- •Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
- •Current smokers (or users of tobacco and vaping products) and subjects with a history of alcohol or drug abuse;
- •An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
- •Individuals with orthodontic bands or removable partial dentures.
- •Dental prophylaxis in the previous 3 months prior to the baseline examination
研究组 & 干预措施
Control
Regular fluoride toothpaste
干预措施: Stannous Fluoride Toothpaste (SnF) (Drug)
Test
Stannous fluoride containing toothpaste
结局指标
主要结局
Gingival Bleeding Index described by Ainamo & Bay, 1976
时间窗: From enrollment and at each successive visit until to the end of the study
Gingival Bleeding Index (Ainamo \& Bay, 1976) The six surfaces of teeth will be scored and recorded for absence or presence of bleeding after gentle probing.
次要结局
未报告次要终点