A modification to the experimental gingivitis protocol to compare the antiplaque properties of two toothpastes

Abstract

Background and Aims: Randomised, blind, controlled experimental gingivitis and home‐use study protocols are used to evaluate the efficacy of oral hygiene products. The present methodological study combined the two clinical trial designs to compare the preventive and therapeutic potentials of two toothpastes. Material and Methods: The study was a parallel group, randomised, double‐blind design, initially involving 73 healthy dentate subjects. A 21‐day experimental gingivitis protocol was combined with a 6‐week (42 days) home‐use protocol. At baseline, modified gingival index (MGI), gingival index (GI) and gingival bleeding (GB) were recorded. A dental prophylaxis was then performed. Subjects were allocated to either control fluoride or stannous fluoride toothpaste based on gender and GI. During the first 21‐day period, subjects applied the allocated toothpaste, for 1 min twice a day, to a group of teeth in a plastic shield and brushed the remaining teeth with the same paste. From day 21 the shield was not placed, and subjects brushed all teeth with the toothpaste for 1 min twice per day up to day 42. MGI, GB and a plaque index (PI) were recorded on days 21 and 42. Results: Sixty‐nine and 67 subjects completed to days 21 and 42, respectively. For shielded teeth, PI, MGI and GB increased to day 21 and then after ceasing the use of the shield decreased to day 42. At day 21, PI favoured the stannous fluoride toothpaste, but differences did not achieve statistical significance for any parameter at days 21 or 42. For unshielded teeth, there were no significant differences between the toothpastes for any parameter at either time point. Conclusion: The feasibility of combining two gingivitis clinical trial methodologies appears proven, and data on both the preventive and therapeutic chemical and mechanical efficacy of toothpastes can be obtained through such protocols. Specifically from the present study and consistent with some other reports, the plaque inhibitory properties of the stannous fluoride product are limited and do not always translate into an antiplaque/antigingivitis effect.