Clinical effect of a new toothpaste formulation on experimental gingivitis

Objectives: It was the aim of the study to evaluate the clinical effect of dentifrices containing Univestin/stannous (U) vs. a placebo (P) using an experimental gingivitis model. Methods: In this double-blind, prospective, parallel and randomized, clinical study, 40 subjects (20 per group) who meet the inclusion/exclusion criteria received a complete prophylaxis and a 3-day hygiene period. Then the volunteers discontinued all oral hygiene measures for 4 teeth using a shield (while they could brush the other teeth normally) and treated the four non-brushed teeth twice daily the assigned toothpaste slurry for 21 days. Gingivitis and supragingival plaque levels were assessed at days 0, 14 and 21 by means of the Löe & Silness (1963) Gingiva and the Silness & Löe (1964) Plaque Index, respectively. The occurrence of adverse events and side-effects was also recorded at each visit. Results:

GI	Placebo (P)	Univestin (U)	p-value P vs. U	PI	Placebo (P)	Univestin (U)	p-value P vs. U
base	0.038 ± 0.058	0.028 ± 0.050	0.563; n.s.	base	0.390 ± 0.238	0.320 ± 0.254	0.375; n.s.
14d	0.820 ± 0.342	0.355 ± 0.243	<0.001; ***	14d	1.835 ± 0.383	1.270 ± 0.285	<0.001; ***
21d	1.585 ± 0.218	0.934 ± 0.239	<0.001; ***	21d	2.250 ± 0.383	1.700 ± 0.229	<0.001; ***

Statistical analysis performed by ANOVA (level of significance p≤0.05)

Conclusion: The results suggest that the new toothpaste formulation was able to significantly reduce the extent of plaque and gingivitis development compared to a placebo paste.

This study was supported by Colgate-Palmolive, Piscataway, USA.