Development of a Novel Anti-caries Chewing Gum
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Change in target species of the oral microbiome
研究概览
简要总结
This research study is designed to evaluate the chewing gum's ability to modulate the oral microbiome in human participants, in addition to its safety.
详细描述
The goal of this project is to develop a pre-biotic chewing gum that is designed to promote a healthy oral microbiome. The gum will contain compounds that will: a) be unable to be converted to acids; b) target the cariogenic S. mutans population; c) promote the stability of a healthy environment by modulating plaque pH via base-generating compounds; d) promote tooth remineralization by increasing saliva flow and by addition of calcium phosphate.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In good general health, no relevant medical history
- •No dental treatment in the previous 3 months
- •Willing to participate and give written informed consent
排除标准
- •Patients undergoing fixed or removable orthodontic treatment
- •Patients using removable prosthesis
- •History of head and neck radiation therapy
- •History of adverse reaction or allergies to xylitol or other additives
- •Antibiotics use in the last four weeks
- •Patients with any systemic diseases
- •Xerostomia (also medication-induced)
- •Currently using any mouth rinse
- •Pregnant or breastfeeding women
结局指标
主要结局
Change in target species of the oral microbiome
时间窗: 28 days
Total microbiome analyses will be performed at the beginning and end of the study (4 weeks) to assess total cultivable flora, levels of S. mutans, S. salivarius, and P. gingivalis in addition to using qRT-PCR from plaque and saliva samples
次要结局
未报告次要终点
研究者
Dennis Cvitkovitch
Professor
University of Toronto