一种新型含稳定亚锡-氟化钠牙膏治疗牙龈炎患者的临床效果评价

摘要

Objective: To evaluate the anti-gingivitis efficacy of a novel stabilized stannous-containing sodium fluoride dentifrice. Methods: A randomized, controlled and double blind clinical study was conducted. 156 adults with gingivitis were enrolled and randomly assigned to experimental group(group of novel stabilized stannous-containing sodium fluoride dentifrice, n = 51), positive control group (group of Yunnan Baiyao dentifrice, n = 54) and negative control group (group of Crest dentifrice, n = 51). Gingival health was assessed using Mazza Modification of the Papillary Bleeding Index(Mazza GI) at Baseline, day 3 and week 4 and pocket depth was evaluated at baseline and week 4, respectively. Results: At day 3 and week 4, the experimental and positive control groups exhibited lower clinical parameters than the negative control group(P＜ 0. 000 1). At week 4, the mean Mazza GI scores and PD of the experimental group were significantly lower than those of the positive control group(P＜ 0. 05). Conclusion: The novel stannous-containing sodium fluoride dentifrice has anti-gingivitis efficacy.%目的: 评估一种新型含稳定亚锡- 氟化钠牙膏治疗牙龈炎的临床效果.方法: 采用随机、对照、双盲的研究方法,纳入成年牙龈炎患者156 名,分为试验组(欧乐B 新型含稳定亚锡- 氟化钠牙膏组,n = 51) 、阳性对照组(市售云南白药牙膏组,n = 54) 和阴性对照组(佳洁士牙膏组,n = 51) ,各组受试者使用相应牙膏刷牙,2 次/d.分别在基线、3 d 和4 周,检查mazza 改良牙龈乳头出血指数(Mazza GI) 和牙龈出血点个数,并在基线和4 周时记录牙周探诊深度(probing depth,PD) .结果: 牙膏使用3 d 和4 周时,试验组和阳性对照组临床指标均较阴性对照组显著改善(P＜ 0. 000 1) ,使用4 周时试验组各项指标均优于阳性对照组(P＜ 0. 05) .结论: 欧乐B 新型含亚锡- 氟化钠牙膏具有抗牙龈炎的效果.