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一种新型含亚锡氟化钠牙膏的脱敏疗效:一项为期8周的随机对照临床试验。

The desensitizing efficacy of a novel stannous-containing sodium fluoride dentifrice: an 8-week randomized and controlled clinical trial.

作者信息

Ni Long Xing, He Tao, Chang Alice, Sun Lily

机构信息

School of Stomatology, Fourth Military Medical University Xian, China.

出版信息

Am J Dent. 2010 Sep;23 Spec No B:17B-21B.

Abstract

PURPOSE

To assess the efficacy of a novel stannous-containing dentifrice in the reduction of dentin hypersensitivity when compared to a marketed positive control dentifrice.

METHODS

An 8-week, single-center, randomized, parallel group, two-treatment, double-blind clinical study was conducted in a generally healthy adult population with moderate thermal and tactile dentin hypersensitivity. A total of 60 adults were enrolled into the study. Participants were stratified at baseline by age, gender, and cold air sensitivity scores, and randomly assigned to either an experimental stannous-containing sodium fluoride dentifrice or a marketed potassium nitrate positive control. Brushing was supervised on site after baseline and Week 4 examinations. All other product usage was unsupervised. Subjects brushed 2 minutes twice daily. At baseline, Week 4 and Week 8, efficacy outcomes were assessed for tactile sensitivity via the Yeaple Probe, and for thermal sensitivity with air-blast/SchiffAir Index.

RESULTS

Fifty-eight subjects completed all evaluations. Both the experimental stannous-containing and positive control dentifrices provided significant (P< 0.05) reductions in both tactile and thermal dentin hypersensitivity compared to baseline at both Weeks 4 and 8. There were no significant differences in Yeaple Probe or Schiff Air Index results between the dentifrices with either efficacy measurement at Week 4 and Week 8 (P > or = 0.5375).

摘要

目的

与市售阳性对照牙膏相比,评估一种新型含亚锡牙膏在减轻牙本质过敏方面的疗效。

方法

在一般健康的、患有中度冷热和触觉牙本质过敏的成年人群中开展了一项为期8周的单中心、随机、平行组、双治疗组、双盲临床研究。共有60名成年人纳入该研究。参与者在基线时按年龄、性别和冷空气敏感评分进行分层,并随机分配至含亚锡氟化钠实验牙膏组或市售硝酸钾阳性对照组。在基线检查和第4周检查后,现场监督刷牙情况。所有其他产品使用情况均无监督。受试者每天刷牙两次,每次2分钟。在基线、第4周和第8周时,通过Yeaple探针评估触觉敏感性,并通过气喷/希夫气指数评估热敏感性,以此评估疗效结果。

结果

58名受试者完成了所有评估。与基线相比,含亚锡实验牙膏和阳性对照牙膏在第4周和第8周时均能显著(P<0.05)减轻触觉和热牙本质过敏。在第4周和第8周的任何一项疗效测量中,两种牙膏在Yeaple探针或希夫气指数结果上均无显著差异(P≥0.5375)。

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