|PerioPatch® is a topical patch designed to relieve the signs and symptoms of inflammation caused by gingivitis and periodontitis. The patch is applied over the inflamed area on the gum and its unique, proprietary bilayer film protects the tissue while absorbing the inflammatory exudates in the tissue and in the gingival crevicular fluid (GCF) that would otherwise perpetuate the inflamed state. A single patch can absorb upwards of 140µl of GCF in one hour, effectively keeping the crevicular space free of inflammatory cytokines and other factors that activate the disease cycle.
Results of an early pilot study indicated that PerioPatch® promotes reduction of gingival inflammation. In a double blind randomized controlled trial conducted in conjunction with the University of Michigan, gingival tissue of patients treated with PerioPatch® demonstrated a marked and statistically significant decrease in inflammation (25%) and in matrix metalloproteinase (MMP) levels in the gingiva in just 24 hours. Patients treated with the placebo showed no significant difference in gingival inflammation.
Additional clinical studies conducted in Israel under the auspices of Sha’are Zedek Hospital also demonstrated significant reduction in gingival inflammation at localized sites throughout the mouth as early as 24 hours; these lowered levels of inflammation were maintained for approximately 30 days, the last time point of the study.
In an FDA-approved Phase II trial performed at Columbia University, PerioPatch® demonstrated an outstanding efficacy and safety profile. A dramatic reduction in inflammation of the gingiva was achieved, which was reflected in a sharp reduction of the level of inflammatory cytokines. This reduction of inflammation was maintained at significant levels throughout the duration of the study. No significant adverse effects were reported.
Other clinical studies have demonstrated a reduction of bleeding on probing and significant clinical benefits when used with scaling and root planing.
PerioPatch® is being marketed to the professional market in the U.S, Israel and Europe.