Parkinson Charles R, Hughes Nathan, Hall Claire, Whelton Helen, Gallob John, Mason Stephen
Am J Dent. 2016 Feb;29(1):25-32.
To assess the short-term efficacy of dentifrices containing 0.454% weight/weight (w/w) stannous fluoride applied using a focused brushing methodology for the relief of dentin hypersensitivity (DH).
Three randomized, examiner blind, controlled, two treatment arm, parallel group studies were conducted utilizing a novel application method in which, prior to brushing the whole mouth, the stannous fluoride dentifrice was applied to two sensitive teeth by focused brushing. DH was assessed with an evaporative (air) stimulus (with the Schiff Sensitivity Scale and a Visual Analogue Scale [VAS, Studies 1 and 3 only]) and a tactile stimulus (using a Yeaple Probe). Clinical assessments were made at baseline, immediately after first use of study dentifrice and after 3 and 14 days of twice daily brushing. Study 1 compared a marketed 0.454% w/w stannous fluoride dentifrice indicated for short-term DH relief to a marketed standard fluoride dentifrice (negative control). Studies 2 and 3 compared a novel anhydrous 0.454% w/w stannous fluoride dentifrice to the same negative control.
For Studies 1, 2 and 3, 118, 113 and 120 subjects respectively were randomized to treatment and included in the intent-to-treat populations. Study 1 showed significant DH improvements in all measures for the test dentifrice compared to the negative control at Day 14. Study 2 showed significant differences in favor of the test dentifrice for all measures at all time points (Immediate, Days 3 and 14). In Study 3, treatment with both test and control dentifrices resulted in significant improvements over baseline, but there were no significant between-treatment differences. While these studies provide evidence for relief of DH with 0.454% w/w stannous fluoride dentifrices after short-term use (14 days) using a novel focused brushing methodology, the evidence, especially at the earliest time points, is inconclusive and further testing is needed. Study dentifrices were well tolerated. ClinicalTrials.gov trial registration numbers: Study 1 NCT01494649; Study 2: NCT01592851; Study 3: NCT01724008; funded by GSK Consumer Healthcare.
评估采用集中刷牙方法使用含0.454%重量/重量（w/w）氟化亚锡的牙膏缓解牙本质过敏（DH）的短期疗效。
进行了三项随机、检查者盲法、对照、双治疗组、平行组研究，采用一种新的应用方法，即在全口刷牙前，通过集中刷牙将氟化亚锡牙膏涂于两颗敏感牙齿上。使用蒸发（空气）刺激（采用希夫敏感量表和视觉模拟量表[仅研究1和3使用]）和触觉刺激（使用耶普尔探针）评估牙本质过敏。在基线、首次使用研究牙膏后立即以及每天刷牙两次3天和14天后进行临床评估。研究1将一种用于短期缓解牙本质过敏的市售0.454%w/w氟化亚锡牙膏与一种市售标准氟化物牙膏（阴性对照）进行比较。研究2和3将一种新型无水0.454%w/w氟化亚锡牙膏与相同的阴性对照进行比较。
研究1、2和3分别有118、113和120名受试者被随机分配至治疗组并纳入意向性分析人群。研究1显示，在第14天，与阴性对照相比，试验牙膏在所有测量指标上牙本质过敏均有显著改善。研究2显示，在所有时间点（即刻、第3天和第14天），试验牙膏在所有测量指标上均有显著优势。在研究3中，试验牙膏和对照牙膏治疗均使情况较基线有显著改善，但治疗组间无显著差异。虽然这些研究为使用新型集中刷牙方法短期使用（14天）0.454%w/w氟化亚锡牙膏缓解牙本质过敏提供了证据，但该证据尤其是在最早时间点上尚无定论，需要进一步测试。研究牙膏耐受性良好。ClinicalTrials.gov试验注册号：研究1 NCT01494649；研究2：NCT01592851；研究3：NCT01724008；由葛兰素史克消费者保健公司资助。
