新型含稳定亚锡-氟化钠牙膏对减轻牙龈炎的功效评估

摘要

AIM:To assess the anti-gingivitis efficacy of a novel stannous-containing dentifrice. METH-ODS:120 generally healthy adults with gingivitis were enrolled intoa 4-week randomized, controlled, double blind, single center,two-treatment, parallel group clinical study. The subjects were randomly assigned to Oral -B novel stannous-containing group(Oral-B group)and NaF dentifrice group(NaF group). Papillary Bleeding Index(Mazza GI) and bleeding siteswere examinedat Baseline, Day 3 and Week 4 afterbaseline by a qualified dental examiner. RESULTS:118 subjects completed the study.At Day 3 the Oral-Bgroup(n=59) provided statistically significant re-duction of Mazza GI scores and number of bleeding sites vs. the NaF control(n=60) (P0.05). At Week 4,Oral-B group showed 17.70% lower GI scores and a 51.40% fewer bleeding sites than NaF group(P0.05). CONCLU-SION:The anti-gingivitiseffect of Oral-B novel stannous-containing sodium fluoride dentifrice is superior than that of NaF dentifrice.%目的:评估新型稳定亚锡-氟化钠牙膏减轻牙龈炎的效果.方法:采用随机、对照、双盲法进行临床试验.选取符合纳入标准的中、重度牙龈炎患者120名,随机分为两组(n=60),试验组用新型稳定亚锡-氟化钠牙膏,对照组使用普通含氟牙膏.两组分别在基线、3 d、4周时评估Mazza改良牙龈指数(Mazza GI)和出血位点数.结果:共118位受试者完成了试验.与基线相比,使用牙膏3 d 后,试验组和对照组的Mazza GI及出血位点数均显著减少(P0.05).连续使用4周后,试验组Mazza GI和出血位点数与3 d后相比下降10.70%和39.00%(P0.05),与对照组相比分别下降17.70%和51.40%(P0.05).结论:新型稳定亚锡-氟化钠牙膏抗牙龈炎功效优于普通含氟牙膏.