Clinical Trial: Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational

Official Title: Rapid Point-of-Care Salivary Diagnostic for Periodontal Health

Brief 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 Summary:

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.

Sponsor: Innovative Diagnostics Inc

Current Primary Outcome: Presence of MMP-8 in the subjects saliva using the Quik Check PD device [ Time Frame: One day. Subjects complete the study in 45 minutes. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Amount of MMP-8 in the subjects saliva sample using Luminex Analysis [ Time Frame: One day. Subjects complete the study in 45 minutes. ]

Original Secondary Outcome: Same as current

Information By: Innovative Diagnostics Inc

Dates:
Date Received: March 23, 2015
Date Started: March 2015
Date Completion:
Last Updated: August 16, 2016
Last Verified: August 2016