Parkinson Charles, Amini Pejmon, Wu Jianming, Gallob John
GSK Consumer Healthcare, Weybridge, Surrey, United Kingdom.
Silverstone Research Group, Las Vegas, Nevada, USA.
Am J Dent. 2018 Feb;31(1):17-23.
To evaluate and compare gingival health, as measured by a bleeding index (BI), a modified gingival index (MGI), a dental plaque index (PI), and number of bleeding sites following twice daily use of an anhydrous 0.454% weight/weight (w/w) stannous fluoride dentifrice (Test Dentifrice) compared to a sodium monofluorophosphate (SMFP) dentifrice (Negative Control) over 24 weeks.
This was a single-center, examiner-blinded, randomized [by gender and baseline mean MGI score (Low ≤ 2.00/High > 2.00)], stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent BI, MGI and PI assessments. Following randomization, eligible subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site with overnight plaque (having abstained from oral hygiene procedures for at least 8 hours) for BI, MGI and PI assessments.
Of 109 screened subjects, 104 were randomized and 98 completed the study. Statistically significant differences between treatments were observed in favor of the Test Dentifrice compared to the Negative Control dentifrice for all outcome measures including not only BI, MGI and PI indices but also number of bleeding sites (P< 0.0001 at Week 12 and Week 24 for all). Data observation showed that the percentage of sites that decreased was more, and those that increased was less, with the Test Dentifrice than with the Negative Control dentifrice at both 12 and 24 weeks. 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) and plaque compared to a SMFP dentifrice over a 24-week period.
通过出血指数（BI）、改良牙龈指数（MGI）、牙菌斑指数（PI）以及每日两次使用无水0.454%重量/重量（w/w）氟化亚锡牙膏（测试牙膏）与单氟磷酸钠（SMFP）牙膏（阴性对照）24周后的出血部位数量，来评估和比较牙龈健康状况。
这是一项单中心、检查者盲法、随机（按性别和基线平均MGI评分：低≤2.00/高>2.00）、分层、双治疗组、平行组、为期24周的临床研究，研究对象为患有中度牙龈炎的健康成年志愿者。在基线时，受试者隔夜不刷牙后，接受BI、MGI和PI评估。随机分组后，符合条件的受试者接受全面的牙齿清洁和牙线清洁。在使用分配的治疗方法每日刷牙两次12周和24周后，受试者带着过夜形成的牙菌斑（至少8小时未进行口腔卫生程序）返回研究地点，进行BI、MGI和PI评估。
在109名筛查的受试者中，104名被随机分组，98名完成了研究。在所有结果指标上，包括BI、MGI和PI指数以及出血部位数量，均观察到治疗组之间存在统计学显著差异，与阴性对照牙膏相比，测试牙膏更具优势（在第12周和第24周时，所有指标P<0.0001）。数据观察表明，在第12周和第24周时，测试牙膏使牙龈部位减少的百分比更高，增加的百分比更低。治疗方法总体耐受性良好。
与SMFP牙膏相比，在24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）和牙菌斑。
