一项评估 62%和 67%碳酸氢钠牙膏对牙龈健康功效的随机临床试验。

PURPOSE

This randomised, examiner-blind, parallel study compared gingival bleeding and plaque control following 12 weeks' twice-daily use of 67%, 62% or 0% sodium bicarbonate (NaHCO3)-containing toothpastes.

MATERIALS AND METHODS

Adults with mild-to-moderate gingivitis, ≥ 20 gingival bleeding sites and bleeding after brushing were randomised to toothpastes containing 923 ppm sodium fluoride and either 67% NaHCO3, 62% NaHCO3 + 5% w/w silica, or 0% NaHCO3. Gingival bleeding was assessed with the Saxton and van der Ouderaa Bleeding Index (BI), plaque was assessed with the Turesky modification of the Quigley-Hein Plaque Index (TPI).

RESULTS

There were significantly fewer bleeding sites at Week 12 (primary endpoint) for 67% NaHCO3 (n = 110) and 62% NaHCO3 (n = 110) groups compared with the 0% NaHCO3 group (n = 110) (treatment differences: -3.1 [97.5% confidence interval (CI) -5.5, -0.7] P = 0.0068 and -2.4 [-4.8, 0.0] P = 0.0448, respectively). Statistically significant differences were also seen at Week 6 (P = 0.0361 for 67% NaHCO3, P = 0.0044 for 62% NaHCO3 compared to 0% NaHCO3). Compared with the 0% NaHCO3 group, BI was significantly lower in the 67% NaHCO3 group at Weeks 6 and 12 (P = 0.0477 and P = 0.0066, respectively). TPI was significantly lower in the 67% NaHCO3 and 62% NaHCO3 groups at Week 6 (P = 0.0336 and 0.0009, respectively) but not at Week 12. No statistically significant differences were found between the 67% NaHCO3 and 62% NaHCO3 toothpastes for any variable. No treatment-related adverse events were reported.

CONCLUSION

Twice-daily brushing over 12 weeks with toothpastes containing 67% NaHCO3 or 62% NaHCO3 significantly improved plaque control and reduced indices of bleeding in participants with mild-to-moderate gingivitis.

目的

本随机、检查者盲、平行研究比较了使用含 67%、62%或 0%碳酸氢钠（NaHCO3）的牙膏，每天两次刷牙 12 周后牙龈出血和菌斑控制情况。

材料和方法

患有轻度至中度牙龈炎、≥20 个牙龈出血部位和刷牙后出血的成年人被随机分配到含有 923 ppm 氟化物和 67%NaHCO3、62%NaHCO3+5%w/w 二氧化硅或 0%NaHCO3 的牙膏中。使用 Saxton 和 van der Ouderaa 出血指数（BI）评估牙龈出血，使用 Turesky 改良的 Quigley-Hein 菌斑指数（TPI）评估菌斑。

结果

与 0%NaHCO3 组（n = 110）相比，第 12 周（主要终点）时 67%NaHCO3（n = 110）和 62%NaHCO3（n = 110）组的出血部位明显减少（治疗差异：-3.1[97.5%置信区间（CI）-5.5，-0.7]P = 0.0068 和-2.4[-4.8，0.0]P = 0.0448）。第 6 周时也观察到统计学上的显著差异（与 0%NaHCO3 相比，67%NaHCO3 组 P = 0.0361，62%NaHCO3 组 P = 0.0044）。与 0%NaHCO3 组相比，第 6 周和第 12 周时，67%NaHCO3 组的 BI 明显较低（P = 0.0477 和 P = 0.0066）。第 6 周时，67%NaHCO3 和 62%NaHCO3 组的 TPI 明显较低（P = 0.0336 和 P = 0.0009），但第 12 周时没有统计学意义。67%NaHCO3 和 62%NaHCO3 牙膏在任何变量上均未发现统计学显著差异。未报告与治疗相关的不良事件。