OPTICAL ASSAY FOR MEASURING COLLAGENASE IN GCF

THIS PROJECT WILL DEVELOP A RAPID ASSAY FOR MEASURING COLLAGENASE ACTIVITY IN GINGIVAL CREVICULAR FLUID (GCF) TO DIAGNOSE PERIODONTAL DISEASE, WHICH IS VERY PREVALENT IN THE U.S. POPULATION, AFFECTING UP TO 75 PERCENT OF ADULTS. MOST DIAGNOSTIC TECHNIQUES AVAILABLE TO CLINICIANS CANNOT PREDICT FUTURE ATTACHMENT LOSS. COLLAGENASE IN GCF IS AN IMPORTANT MARKER OF DISEASE ACTIVITY, BUT PREVIOUS METHODS HAVE BEEN UNSUITABLE FOR CLINICAL USE. BIOSTAR MEDICAL PRODUCTS, INC., WILL DEVELOP OIA TECHNOLOGY FOR THE DIRECT PHYSICAL DETECTION OF COLLAGENASE ACTIVITY. THIS TECHNOLOGY EXPLOITS THE OPTICAL PROPERTIES OF THIN FILMS OF BIOMOLECULES ON A PATENTED TEST PIECE; AS THICKNESSDECREASES DUE TO ENZYMATIC DIGESTION, A COLOR CHANGE OCCURS. RESULTS WILL BE AVAILABLE IN MINUTES. EASE OF USE AND LOW COST MAKE IT SUITABLE FOR OFFICE USE. RESULTS WILL BE SEMIQUANTITATIVE, DIFFERENTIATING BETWEEN HEALTH, GINGIVITIS, AND ACTIVE PERIODONTITIS. THE SPECIFIC AIMS OF PHASE I ARE TO DETERMINE THE BEST METHOD FOR IMMOBILIZING COLLAGEN ON THE TEST PIECE SO PURE COLLAGENASE CAN MEASURABLY DEGRADE IT, AND TO DETERMINE THE CONDITIONS THAT ALLOW DIFFERENTIATION OF CLINICALLY RELEVANTENZYME LEVELS. THE PROTOTYPE DEVELOPED IN PHASE I WILL BE EVALUATED AND MODIFIED DURING CLINICAL STUDIES IN PHASE II DEVELOPMENT.