Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis and the proportion of subjects moving between gingivitis severity (< 10, > 10 < 30, > 30% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks. This was a single-center, examiner-blinded, randomized, 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 MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High > 2.00) and randomized to treatment. Following randomization, 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 8 h prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores. One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p < 0.0001). At 24 weeks, 71% of subjects in the 0.453% SnF2 treatment group demonstrated < 10% of bleeding sites. A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of “clinical periodontal health” (< 10%) following a dental prophylaxis and 24 weeks of product use. This study was retrospectively registered at ClinicalTrials.gov, on 11th Oct. 2019 (NCT04123665).

中文翻译：

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0.454％w / w氟化亚锡洁齿剂的牙龈炎疗效：24周随机对照试验。

可以通过定期有效的口腔卫生（主要是通过定期用牙刷进行机械清洁）来预防和治疗牙菌斑诱发的牙龈炎。为了补充去除机械斑块，可以将抗菌成分掺入洁齿剂中以抑制斑块的生长。这项研究旨在评估和比较每天两次使用非水性0.454％重量的实验性牙龈炎以及在牙龈炎严重程度（<10，> 10 <30，> 30％出血部位之间）和牙菌斑减少之间移动的受试者的比例/重量（w / w）氟化亚锡（SnF2）洁牙剂，在12和24周内与阴性对照洁牙剂相比。这是一项针对中度牙龈炎的健康成人志愿者的单中心，双盲，随机，分层，两次治疗，平行治疗的为期24周的临床研究。在基线时，在禁止牙刷过夜后，对受试者进行MGI（改良牙龈指数），BI（出血指数）和PI（牙菌斑指数）评估。符合纳入/排除标准的符合条件的受试者根据性别和基线平均MGI得分（低≤2.00/高> 2.00）进行分层，并随机分配至治疗组。随机分组后，对受试者进行彻底的牙齿预防和牙线剔除。在每天和每天两次刷牙并分配治疗后的12和24周后，受试者返回该部位（有过夜斑块，在就诊前8小时不做口腔卫生操作）进行MGI，BI和PI评估。通过比较MGI，BI和PI评分评估治疗效果。筛选了129名受试者；98名受试者被随机分组​​，90名受试者完成了研究。对于所有结局指标（MGI，BI，出血部位和PI在第12周和第24周时，P <0.0001），与阴性对照相比，治疗之间观察到统计学上的显着差异，有利于0.454％的氟化亚锡洁齿剂。在第24周时，0.453％SnF2治疗组中71％的受试者表现出<10％的出血部位。在24周内，含有0.454％w / w SnF2的洁牙剂在控制牙龈炎和龈上菌斑方面优于标准洁牙剂。0.454％SnF2治疗组中超过三分之二的受试者表现出一定程度的出血部位，这些部位可能代表预防牙科和使用产品24周后的“临床牙周健康”（<10％）。这项研究于10月11日在ClinicalTrials.gov进行了回顾性注册。