A multicenter clinical trial of PerioGardTM in distinguishing between diseased and healthy periodontal sites

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Abstract
We designed and performed a multicenter clinical trial to determine the relationship between measurements of the level of the enzyme aspartate amino‐transferase (AST) in gingival crevicular fluid (GCF) to other measures used to detect periodontal disease and monitor outcome of treatment, including pocket depth and gingival inflammation. 32 periodontitis patients were enrolled at the University of Washington, Seattle, 30 at the University of Florida, Gainesville, and 34 at the University of Illinois, Chicago. 10 periodontally normal control subjects were enrolled at each location. 8 diseased and 4 healthy sites were designated for study in each patient and 8 healthy sites designated in each control subject. Measures of disease included pocket depth, severity of gingival inflammation, and GCF volume. AST levels were measured using the PerioGardTM test kit. Clinical measurements were made and GCF samples harvested and tested 2X before and 2X after therapy consisting of scaling and root planing under local anesthetic. Specific design and other issues are discussed, including selection of patients and control subjects, sample size, selection of experimental test sites, methods for assessment of diseased and therapeutic improvement, harvesting of GCF, and selection of appropriate biostatistical methods for data analysis. Demographics of the patient populations at the 3 locations are reported. As expected, therapy induced only negligible changes in the measures of disease at healthy sites in control subjects, and relatively minor improvement in healthy sites in patients. In contrast, statistically significant improvement relative to pre‐treatment baseline status in all 3 measures of disease was observed for diseased sites at all 3 study locations with all p‐values less than 0.0002. The magnitude of improvement was comparable to that reported previously by others. The % of PerioGard‐positive sites decreased significantly between the screening baseline and both post‐treatment visits for patients at all 3 locations, with p values of 0.0001 to < 0.0008.