A randomized controlled trial evaluating the efficacy of a 67% sodium bicarbonate toothpaste on gingivitis. Issue 4 (22nd May 2016) - Lomax, A
Abstract: Introduction: In previous studies, toothpastes with high levels of sodium bicarbonate (>50%) have reduced gingival inflammation and oral malodour. This study compared the effects of brushing for 6 weeks with 67% (test group) or 0% (control group) sodium bicarbonate toothpaste on gingival health. Methods: This was a single‐centre, single examiner‐blind, randomized, controlled, two‐treatment, parallel‐group study. Eligible subjects (≥18 years) had ≥20 gradable teeth, mild‐to‐moderate gingivitis, a positive response to bleeding on brushing and ≥20 bleeding sites. The primary objective was to compare the number of bleeding sites following twice‐daily use of 67% sodium bicarbonate toothpaste or 0% sodium bicarbonate toothpaste after 6 weeks. Secondary endpoints included Modified Gingival Index (MGI), Bleeding Index (BI) and volatile sulphur compounds (VSC), assessed after 6 weeks. Safety was assessed by treatment‐emergent oral soft tissue abnormalities and adverse events. Results: Of 148 patients randomized (74 to each treatment), 66 (89.2%) completed the study in the test group, compared with 69 (93.2%) in the control group. Compared with the control group, the test group had a significant reduction in the number of bleeding sites at Week 6 (absolute difference – 11.0 [−14.0, −8.0], P < 0.0001; relative difference – 25.4%), together with significant reductions in MGI and BI (both P < 0.0001). Although the median reductions from baseline for VSC were numerically greater in the test group, the difference did not reach statistical significance ( P = 0.9701). Conclusions: This 67% sodium bicarbonate toothpaste provided statistically significant improvements in gingival health and bleeding after 6 weeks of use.