The dental profession has searched for many years for additional """"""""real time"""""""" chair-side measures to provide objective measures to aid in the monitoring of periodontal health and early diagnosis of disease. Research efforts have produced solid evidence that constituents present in saliva can provide important complimentary diagnostic information, and have the potential for point-of-care (POC) device use by dental/healthcare professionals and the general public. Of the many biomarkers demonstrated in saliva, accumulated evidence shows that matrix metalloproteinase (MMP)-8 has high sensitivity and specificity for discriminating periodontal disease from health and is present at a high concentration in saliva. Yet, rapid, chairside, biochemical tests that utilize this informatio for risk assessment of periodontal disease are not yet available in the U.S. We are developing a hand held (1.5 x 3 inch) POC device that detects MMP-8 in saliva. This device, designated """"""""Quik-'PD"""""""", measures MMP-8 by lateral flow chromatography. Our recent findings involving the sensitivity, specificity and accuracy of this device suggest that this product is commercially viable and potentially effective for assessing the risk for periodontitis. The goals of this Phase SBIR proposal are to confirm the accuracy of the device for detecting a broad range of MMP-8 concentrations in saliva, to develop a smartphone app to evaluate results, and to establish a pathway for FDA approval. Phase I of the SBIR funded research involves testing the accuracy of the device using saliva from 174 participants. The Phase II SBIR will be a large validation study involving thousands of participants, which is required to meet FDA guidelines. The Phase I study has three Specific Aims:
Aim 1 : Determine the accuracy of Quik-'PD for detecting MMP-8 levels in saliva Aim 2: Develop prototype software for detection of results Aim 3: Establish regulatory feasibility
Periodontal disease is an inflammatory and destructive disease that silently affects millions of people. The purpose of this study is to develop a novel point-of-care device that evaluates human saliva in order to provide a simple, rapid, non-invasive, highly sensitive and accurate diagnostic risk assessment for periodontitis.