Gingivitis and Malodor Improvement With the Use of Two-Step System

Objectives: A randomized, negatively-controlled clinical trial was conducted to evaluate the changes in gingival health and oral malodor in response to using a two-step oral hygiene system.

Methods: After IRB review, informed consent was obtained from 49 adult volunteers with existing gingivitis and oral malodor. After one week of acclimation with a regular anti-cavity dentifrice and manual brush subjects were randomly assigned to one of two groups: 1) two-step, 0.454% SnF2 then 3.3% Sodium pyrophosphate, sequence or 2) regular 0.76% NaMFP paste (Colgate® Cavity Protection). Test products were dispensed with a regular manual brush in blinded over-labeled kits for twice daily use. Oral safety, gingival health and hedonic breath evaluations were performed at Baseline, and after one and four weeks of product use.

Results: Fourty nine subjects (59% female) with an average age of 42.2 years were enrolled, and 47 completed the study. At Week 1 and Week 4, the two-step system exhibited significantly lower (p<0.0001) number of bleeding sites compared to control by 52% and 75%, respectively. Loë-Silness Gingivitis scores were also significantly lower (p<0.0001) at both time points compared to control by 20% and 24.6%, respectively. At Week 1 and Week 4, both groups demonstrated significantly (p≤0.035) lower mean malodor values relative to Baseline. Comparing treatments, the two-step system exhibited significantly lower (p<0.0001) hedonic malodor score compared to control by 38.6% and 59.8% at Week 1 and 4, respectively. Products were well tolerated.

Conclusions: This clinical study demonstrated statistically significant improvements in gingivitis, number of bleeding sites and oral malodor over a four-week usage of the two-step system.