A phase II trial of a transmucosal herbal patch for the treatment of gingivitis.

ABSTRACT

BACKGROUND: Systemic treatments for gingivitis frequently are inadequate for controlling specific sites of severe gingival inflammation. The authors conducted a study to test site-specific therapy using a transmucosal herbal periodontal patch (THPP) that was impregnated with plant extracts reported to reduce inflammatory response. METHODS: The study was a single-center, randomized, placebo-controlled, double-masked, longitudinal phase II trial involving participants with clinically diagnosed gingivitis. Participants who were enrolled in the study received either THPPs or placebo patches (PP) for three days. The authors evaluated gingival inflammation visually using the gingival index (GI) and by measuring gingival crevicular fluid ß-glucuronidase (BG) enzymatic activity at baseline (day one) and on days two, four, eight and 15. RESULTS: The authors randomly assigned 53 participants to receive the THPP or the PP. Participants who received the THPPs had a greater reduction in mean GI scores than did those who received the PPs. This finding was significant on days four and 15. The percentage of participants whose GI scores decreased by one or more was higher among those receiving the THPP than among those receiving the PP, as assessed on days four and 15. The average decrease in BG levels (fluorescence units) for participants receiving the THPP was significantly greater on days four and eight than they were for those receiving the PP. No serious adverse events were associated with the use of the THPP. CONCLUSIONS: Topical treatment by means of the THPP may be effective and safe in reducing topical gingival inflammation. Further studies are needed to confirm these findings and determine the best method for administering the THPP and the appropriate dosing. CLINICAL IMPLICATIONS Site-specific treatment of gingival inflammation is feasible and could be used as an adjunct for systemic therapeutic interventions.