Clinical Research Study to Evaluate the Effect of Colgate Mouthwashes on Oral Microbiome in Oral Tissue Samples
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Microbiome
研究概览
简要总结
The purpose of this clinical research study is to investigate if mouthwashes to be tested can affect oral mucosal wound healing and change the oral microbiome (bacteria colonization) or expression of selected biomarkers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female volunteers 18-45 years of age.
- •Good general health.
- •Must sign informed consent form.
- •Minimum of 17 natural uncrowned teeth (excluding third molars) must be present.
- •Exclusion Criteria
- •Oral pathology, chronic disease, or history of allergy to testing product.
- •Medical condition which requires pre-medication prior to dental visits/procedures
- •Moderate or advanced periodontal disease (gum disease) or periodontal probing depths greater than 4 mm.
- •Five (5) or more decayed untreated dental sites at screening (cavities).
- •Impaired salivary function.
- •Use of medications that can currently affect salivary flow.
- •Use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, antibiotics, antimicrobial, anti-inflammatory medication or daily analgesics within 30 days prior to the start of the study or scheduled to start such intake during the course of the study.
- •Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine)
- •Pregnant or nursing women.
- •Participation in any other clinical study within 1 week prior to enrollment into this study.
- •Use of any tobacco products.
- •Subjects who must receive dental treatment during the study dates.
- •Presence of an orthodontic appliance that interferes with required clinical assessments.
- •History of allergy to common dentifrice ingredients.
- •Subjects who wear night guard, denture retainers
- •Not willing to abstain from eating crunchy (eg. Granola bars, popcorns, nuts etc) or spicy and hot foods/liquids during the study period;
- •Not willing to abstain from drinking citrus fluids, alcohol, and tea during the study period
- •Non English-speaking subjects
排除标准
- 未提供
结局指标
主要结局
Microbiome
时间窗: 5 Days
Swabs will be collected from the hard palate on both the wounded and unwounded sides before and after injury and the mouthwash treatment at days 1, 3, 5, and 7. 16S rRNA sequencing will be performed to determine the bacteria microbiome. Correlations and relative abundance of bacteria will be compared at phylum and genus levels using bioinformatics tools between a mouthwash treated group and its placebo at different time points.
Wound healing
时间窗: 7 Days
Images of the oral wounds will be taken before and after using the mouthwash treatment on days 1, 3, 5, and 7. The images will be taken on a digital camera. The wound sizes will be measured in mm2 using ImageJ software. The wound size will be measured at each time point and will be compared between a tested mouthwash and its placebo.
次要结局
- Biomarker expression(3 Days)
研究者
Praveen Kumar Gajendrareddy
Professor
University of Illinois at Chicago