NCT02403297

Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 93 (actual)
• Sponsor: Innovative Diagnostics Inc · Industry
• Sex: All
• Age: 18 Years – 95 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Gingivitis
• Periodontal Disease

Interventions

Type	Name	Description
DEVICE	Quik Check PD	The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-11-01
• Completion: 2016-05-01
• First posted: 2015-03-31
• Last updated: 2016-08-17

Locations

1 site across 1 country: United States