跳至主要内容
临床试验/NCT04005417
NCT04005417已完成不适用

Bioavailable Stannous Fluoride Dentifrice Meta-Analyses: Effects on Dentine Hypersensitivity and Enamel Erosion

Procter and Gamble1 个研究点 分布在 1 个国家目标入组 1,036 人开始时间: 2018年1月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,036
试验地点
1
主要终点
Change from Baseline Air Challenge

研究概览

简要总结

The aim of this 11 study analysis was to compare the effect of bioavailable stannous fluoride (SnF2) on dentine hypersensitivity versus a positive or negative control dentifrice.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Stannous fluoride dentifrice

Twice daily brushing

干预措施: Stannous fluoride dentifrice (Drug)

Positive control dentifrice

Twice daily brushing

干预措施: Positive control dentifrice (Drug)

Negative control dentifrice

Twice daily brushing

干预措施: Negative control dentifrice (Drug)

结局指标

主要结局

Change from Baseline Air Challenge

时间窗: Up to 8 weeks

The Schiff Sensitivity Scale is assessed for each test tooth via an evaporative air challenge. The examiner records the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth.

Change from Baseline in Tactile Threshold

时间窗: Up to 8 weeks

Tactile Threshold is measured using a Yeaple probe. Testing is performed beginning at 10 g. The examiner records tactile scores for responding teeth. After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increases until a "yes" response is repeated. If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and is recorded as the threshold on the Tactile Sensitivity Score form.

次要结局

未报告次要终点

研究者

发起方
Procter and Gamble
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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