Parkinson Charles Richard, Amini Pejmon, Jose Anto, Gallob John
GlaxoSmithKline Consumer Healthcare, Weybridge, Surrey, United Kingdom.
Silverstone Research Group, Las Vegas, NV, USA.
Am J Dent. 2018 Apr;31(2):81-85.
To evaluate and compare gingival health, as measured by a bleeding index (BI), a modified gingival index (MGI), number of bleeding sites, and blood in expectorate following twice daily use of a non-aqueous 0.454% weight/weight (w/w) stannous fluoride dentifrice ('Test dentifrice') compared to a sodium monofluorophosphate (SMFP) dentifrice (' Negative Control') over 12 weeks, in subjects with moderate gingivitis and gingival bleeding following tooth brushing.
This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 12-week clinical study in healthy adult volunteers with moderate gingivitis who demonstrated gingival bleeding following tooth brushing. Subjects were assessed at baseline for MGI, visible blood in dentifrice expectorate and BI. Following randomization, eligible subjects underwent a thorough dental prophylaxis and flossing. After 4 and 12 weeks of twice daily brushing with their allocated treatment, subjects returned to the site for MGI, visible blood in dentifrice expectorate, and BI assessments.
Of 317 screened subjects, 253 were randomized, and 238 completed the study. Statistically significant differences between treatments were observed in favor of the Test dentifrice compared to the Negative Control dentifrice in terms of gingival bleeding (number of bleeding sites and bleeding index), and visual signs of gingival inflammation (MGI) (P< 0.0001 at Weeks 4 and 12 for all). The visual assessment of the level of blood in expectorate following brushing demonstrated large reductions from baseline, however no significant difference between treatments was observed. Treatments were generally well tolerated.
Use of a dentifrice containing 0.454% w/w stannous fluoride led to significantly greater control of gingivitis (gingival bleeding and visual signs of gingival inflammation) compared to a SMFP dentifrice over a 12-week period. This study was conducted in subjects with moderate gingivitis and in a population represented by individuals who experience gingival bleeding on brushing, and is therefore considered representative of individuals who may opt for treatment therapies in the form of a daily use toothpaste.
通过出血指数（BI）、改良牙龈指数（MGI）、出血部位数量以及刷牙后痰中带血情况，评估并比较每天使用两次非水基0.454%重量/重量（w/w）氟化亚锡牙膏（“试验牙膏”）与单氟磷酸钠（SMFP）牙膏（“阴性对照”）12周后，中度牙龈炎且刷牙后牙龈出血的受试者的牙龈健康状况。
这是一项单中心、检查者盲法、随机、分层、双治疗组、平行组、为期12周的临床研究，研究对象为患有中度牙龈炎且刷牙后牙龈出血的健康成年志愿者。在基线时对受试者进行MGI、牙膏咳出物中可见血液以及BI评估。随机分组后，符合条件的受试者接受全面的牙齿预防治疗和牙线清洁。在每天使用分配的治疗牙膏刷牙4周和12周后，受试者返回研究地点进行MGI、牙膏咳出物中可见血液以及BI评估。
在317名筛查受试者中，253名被随机分组，238名完成了研究。在牙龈出血（出血部位数量和出血指数）以及牙龈炎症的视觉体征（MGI）方面，与阴性对照牙膏相比，试验牙膏的治疗效果具有统计学意义上的显著差异（第4周和第12周时所有指标P<0.0001）。刷牙后痰中带血水平的视觉评估显示，与基线相比有大幅下降，但各治疗组之间未观察到显著差异。各治疗方法总体耐受性良好。
与SMFP牙膏相比，在12周期间，使用含0.454%w/w氟化亚锡的牙膏能更显著地控制牙龈炎（牙龈出血和牙龈炎症的视觉体征）。本研究针对中度牙龈炎受试者以及刷牙时牙龈出血的人群进行，因此被认为代表了可能选择日常使用牙膏形式治疗方法的个体。
