Rapid Point-of-Care Salivary Diagnostic for Periodontal Health
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Presence of MMP-8 in the subjects saliva using the Quik Check PD device
研究概览
简要总结
The purpose of this study is to learn if a chair-side testing device will accurately measure levels of a salivary biomarker and thus indicate if a patient has periodontal health, gingivitis or periodontal disease.
详细描述
Human subjects will participate in this cross-sectional study by attending a single visit where their mouth will be examined and saliva will be collected to help determine the accuracy of a POC salivary diagnostic device. The study population will consist of 174 persons (58 that are orally healthy and have no oral discomfort; 58 that have gingivitis; and 58 that have periodontitis. The device results (i.e., visual and optical scans) will be compared against the Luminex results by two methods: 1) the Bland-Altman procedure and 2) discriminant analysis that examines whether the concentration would correctly identify the subject as health or disease using a defined threshold for MMP-8 levels.
Three groups of individuals will be recruited: those that are orally healthy and do not have any oral discomfort (N=58), those who have gingivitis (i.e., bleeding gums; N=58), and those who have periodontal disease (N=58). The groups will be matched by gender and smoking status. Women are predicted to account for 50% of the participants. The age distribution will be 18 to 95 years. Subjects will not be excluded based on race, gender, or ethnicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males or females of all racial and ethnic groups over 18 years of age;
- •At least 20 erupted teeth and the ability to provide expectorated saliva;
- •Able and willing to comply with study requirements; and
- •Have full understanding of all elements of, and signature and dating of the written informed consent prior to the initiation of protocol specified procedures
排除标准
- •Prisoners or institutionalized individuals;
- •Persons with acute illness or infectious disease (as evidenced by fever, malaise, sore throat, recurrent cough, lymphadenopathy, swelling and/or a physician consultation);
- •Evidence of oral mucosal lesion or ulceration; or
- •Use of glucocorticoids or cyclooxygenase inhibitors (i.e. such as ibuprofen, Naprosyn(Aleve) or non-steroidal anti-inflammatory drug) daily for the past two weeks.
结局指标
主要结局
Presence of MMP-8 in the subjects saliva using the Quik Check PD device
时间窗: One day. Subjects complete the study in 45 minutes.
次要结局
- Amount of MMP-8 in the subjects saliva sample using Luminex Analysis(One day. Subjects complete the study in 45 minutes.)