Perlich M A, Bacca L A, Bollmer B W, Lanzalaco A C, McClanahan S F, Sewak L K, Beiswanger B B, Eichold W A, Hull J R, Jackson R D
The Procter and Gamble Company, Sharon Woods Technical Center, Cincinnati, Ohio, USA.
J Clin Dent. 1995;6 Spec No:54-8.
The effects of a stabilized 0.454% stannous fluoride dentifrice, currently marketed as Crest Gum Care, on supragingival plaque, gingivitis, gingival bleeding and oral soft tissue condition were studied in 328 adult male and female subjects who completed a six-month, double blind clinical study. Following initial examinations, subjects presenting with a minimum of five gingival bleeding sites received a thorough dental prophylaxis and were instructed to brush at least twice a day for three months with a commercially available fluoride dentifrice, packaged in such a way as to blind its identity to the study subjects. This constituted the three-month pre-test period. At the end of this period, subjects were again examined, given a second oral prophylaxis, and randomly assigned to brush with one of the following dentifrices: 1) stabilized 0.454% stannous fluoride, 2) 0.243% sodium fluoride control, or 3) one of three experimental dentifrices. Subjects were instructed to brush their teeth as they normally would, at least twice a day for one minute per brushing. Follow-up examinations after three and six months of dentifrice use evaluated supragingival plaque, gingivitis, gingival bleeding, extrinsic tooth stain and oral soft tissue status. After six months, the stabilized stannous fluoride dentifrice significantly reduced gingivitis and gingival bleeding by 20.5% and 33.4% compared to the sodium fluoride control group. However, the stabilized stannous fluoride dentifrice group was not significantly different from the control dentifrice group with respect to supragingival plaque scores. As expected, accumulation of extrinsic tooth stain was greater in the stabilized stannous fluoride group than the control group. No unexpected nor clinically significant oral soft tissue health effects were associated with the use of the test dentifrices. The results from this clinical study demonstrate that over a six-month period, twice-daily use of a dentifrice containing 0.454% stabilized stannous fluoride significantly reduced gingivitis and gingival bleeding, relative to a 0.243% sodium fluoride control dentifrice.
对328名成年男性和女性受试者进行了一项为期六个月的双盲临床研究，研究了目前作为佳洁士牙龈护理牙膏销售的0.454%稳定氟化亚锡牙膏对龈上菌斑、牙龈炎、牙龈出血和口腔软组织状况的影响。在初始检查后，至少有五个牙龈出血部位的受试者接受了全面的牙齿洁治，并被指示每天至少刷牙两次，持续三个月，使用一种市售含氟牙膏，其包装方式使研究对象无法知晓其品牌。这构成了为期三个月的预测试期。在此期间结束时，再次对受试者进行检查，进行第二次口腔洁治，并随机分配使用以下牙膏之一刷牙：1）0.454%稳定氟化亚锡牙膏，2）0.243%氟化钠对照牙膏，或3）三种实验牙膏之一。受试者被指示按正常习惯刷牙，每天至少两次，每次刷牙一分钟。在使用牙膏三个月和六个月后进行的随访检查评估了龈上菌斑、牙龈炎、牙龈出血、外源性牙齿染色和口腔软组织状况。六个月后，与氟化钠对照组相比，稳定氟化亚锡牙膏使牙龈炎和牙龈出血分别显著降低了20.5%和33.4%。然而，稳定氟化亚锡牙膏组在龈上菌斑评分方面与对照牙膏组没有显著差异。正如预期的那样，稳定氟化亚锡组的外源性牙齿染色积累比对照组更多。使用测试牙膏未发现意外的或具有临床意义的口腔软组织健康影响。这项临床研究的结果表明，在六个月的时间里，相对于0.243%氟化钠对照牙膏，每天两次使用含0.454%稳定氟化亚锡的牙膏可显著降低牙龈炎和牙龈出血。
