Non-Invasive Oral Biofilm Characterization
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in gingival perfusion
研究概览
简要总结
There is a need for toothpastes that more effectively remove oral plaque and prevent re-formation. The objective of this study is to map the development and resolution of clinical gingivitis using conventional clinical examination and imaging data to determine how useful imaging techniques can be for evaluating how well a toothpaste cleans the teeth
详细描述
The researcher can use imaging techniques to map changes in gingival blood flow during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard
The researcher can use imaging techniques to map inflammatory microstructural changes in the oral mucosa including swelling, vasodilation and edema during the development and resolution of fully reversible, early clinical gingivitis using standard-of-care clinical indices as gold standard
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult male or female 18-25 years of age
- •Volunteers with gingivitis but no periodontitis
排除标准
- •Subjects who must receive dental treatment during the study dates.
- •History of significant adverse effects following use of oral hygiene products such as toothpastes and mouth rinses. Allergy to personal care/consumer products or their ingredients.
- •Individuals who have taken antibiotics in the previous 3 months
- •Individuals who are pregnant or nursing
结局指标
主要结局
Changes in gingival perfusion
时间窗: up to 6 weeks
optical measurements
次要结局
未报告次要终点
研究者
Beckman Laser Institute and Medical Center
Petra Wilder-Smith, DDS., PhD., Professor, Director of Dentistry
University of California, Irvine