Effects of octenidine mouthrinse on plaque formation and gingivitis in humans

Abstract

Octenidine, a new bispyridine mouthrinse, has been shown to prevent plaque formation in humans over a seven‐day period. The purpose of the present study was to determine the effects of octenidine on plaque and gingivitis development in humans using a 21‐day experimental gingivitis model. Eighty‐eight subjects with a Plaque Index (PII) and Gingival Index (GI) ≤ 0.4 were randomly assigned to 4 coded formulations: 1) 0.1% octenidine in mouthwash vehicle used 3 times a day (TID), 2) 0.1% octenidine in mouthwash vehicle used twice a day (BID), placebo rinse once a day, 3) 0.1% octenidine in water used 3 times a day, and 4) mouthwash vehicle alone used 3 times a day (VEH). Each subject refrained from all mechanical plaque control and rinsed morning, noon, and evening under supervision with 15 ml of assigned formulation for 60 s. At 0, 7, 14, and 21 days, Pit, GI, and mucosal tolerance were assessed. Tooth stain was measured at day 0 and twice at day 21 (prior to and immediately following a single toothbrushing). By day seven of the rinse phase, significant mucosal irritation had occurred in several subjects in the octenidine in water group. Therefore, that group was discontinued from the study and the remaining 66 subjects continued. The mean PII increased in the VEH group from a mean of 0.13 at day 0 to 1.08, 1.39, and 1.69 at days 7, 14, and 21, respectively. In contrast, the mean PII of the TID and BID groups did not increase over the 21 day period (0.14 and 0.10, 0.18 and 0.22, 0.15 and 0.16, 0.12 and 0.16 at day 0, 7, 14, and 21 for TID and BID, respectively). Although the TID and BID groups did not statistically differ at any point, both groups demonstrated significantly less plaque accumulation than the VEH group at days 7, 14, and 21 (p < 0.000001). Gingivitis, as measured by GI, increased significantly in the VEH group from a mean of 0.14 at day 0, to 0.58, 0.84 and 0.98 at day 7, 14, and 21. Both the TID and BID groups demonstrated a small increase in mean GI, rising from 0.12 and 0.16 at day 0 to 0.21 and 0.24, 0.29 and 0.27, and 0.32 and 0.31 at days 7, 14, and 21 for TID and BID, respectively. Again, the TID and BID groups were not different while both had significantly less gingivitis than the VEH group at days 7, 14, and 21 (p 0.000002). Stain, observed in 26 subjects in the TID and BID groups at day 21, was removed by a single toothbrushing in all but 5 subjects. No significant adverse reactions were observed in the remaining subjects. These results demonstrate that octenidine, when used as the only means of oral hygiene for 21 days, will significantly inhibit the development of plaque and gingivitis.

An in vitro Oral Biofilm Model for Comparing the Efficacy of Antimicrobial Mouthrinses

“…It should be noted, however, that despite the lack of a significant difference in vitro between Hexoral and Corsodyl masked by the large variation for Hexoral, there was still a log step difference in biofilm CFUs following treatment with the two products. Twicedaily mouthrinsing with a formulation containing 0.1% octenidine almost completely inhibited plaque formation in a 7-day plaque regrowth trial [Patters et al, 1983] and during 21 days in the absence of mechanical toothcleaning [Patters et al, 1986], and these observations were confirmed in a 3-month clinical trial [Beiswanger et al, 1990]. These data are consistent with the nearly complete eradication of viable counts by Octenisept Colourless observed in our biofilm model.…”

Evaluation of the antimicrobial activities of chlorhexidine gluconate, sodium hypochlorite and octenidine hydrochloride in vitro

“…Octenidine hydrochloride (OCT), developed by Sterlig Winthrop Research Institute, is a bispyridine derivative, that is, N,N'‐[1,10‐decanediyldi‐1(4H)‐pyridinyl‐4‐ylidene] bis(1‐octanamine) dihydrochloride. The existing information suggests that a mouthrinse containing 0.1% OCT may be capable of exerting beneficial clinical effects upon plaque accumulation and gingivitis development (11–15). In oral rinse form, OCT was reported to inhibit dental plaque and caries in rats (16) and in humans (13).…”

The effect of a combination of 0.1% octenidine dihydrochloride and 2% 2‐phenoxyethanol (octenisept®) on wound healing in pigs in vivo and its in vitro percutaneous permeation through intact and barrier disrupted porcine skin

“…Stability is given in the pH range 1·6–12·2, and under exposition to light and in contrast to chlorhexidine chloride OCT is not sensitive to hydrolysis and shows no reduction in the effect as a result of albumin or mucin (protein error) (1). It is levurocidal, effective against resident skin microflora and effects Gram positive and negative as well as plaque‐forming bacteria (1,3–8). Antibacterial effects of OCT on the oral microflora in vivo and in vitro are comparable to those of chlorhexidine gluconate and povidone‐iodine (9).…”