2 MULTICENTER TRIALS ASSESSING THE CLINICAL EFFICACY OF 5-PERCENT SANGUINARINE IN A BIODEGRADABLE DRUG-DELIVERY SYSTEM

A biodegradable drug delivery system containing 5% sanguinarium (Sa) w as compared to vehicle control (VC), scaling and root planing (SRP), a nd supragingival plaque control (SPC) in the treatment of adult period ontitis in 2 well-controlled clinical trials, Studies were 4-quadrant (split mouth) designs at 2 centers each, having 94 (Study A) and 107 ( Study B) patients. All patients had at least 3 pockets between 5 and 9 mm that bled on probing, in each quadrant, Probing pocket depth (PD), clinical attachment level (AL), bleeding on probing (BOP), and plaque index were recorded at baseline, 14, 30, 60, and 90 days. All treatme nts gave statistically significant reductions from baseline for PD and BOP, and significant gains for AL. For PD reduction, SRP was superior to all test groups at all time points in both studies (p<0,001), Sa w as superior to VC in Study A at 14 and 30 days and to SPC at all time points. For AL gain at 90 days, in both studies, SRP gave gains of 0.4 2 and 0.78 mm respectively with superiority seen over the SPC group at 90 days (p<0.001) in study A only, For BOP reduction, in Study A SRP was superior to Sa, VC, and SPC at 60 and 90 days (p<0.005) and in Stu dy B superiority to Sa and VC was at 90 days and to SPC at 60 days (p< 0.05). Sa was superior to VC for pocket depth in deep pockets only. Sa failed to demonstrate superiority over VC on a consistent basis. Anal ysis of residual Sa indicates that Sa potency was insufficient to show an advantage beyond clinical effects inherent in treatments with VC a nd SPC.