Grimaldi Roberta, Baker Sarah R, Shah Parth, Sanchez Edwin, Shanga Gilbert, Gomez-Pereira Paola R, Parkinson Charlie R
Haleon, Weybridge, Surrey, UK.
School of Clinical Dentistry, University of Sheffield, Sheffield, UK.
J Clin Periodontol. 2025 Jul;52(7):940-948. doi: 10.1111/jcpe.14155. Epub 2025 Apr 1.
To evaluate the impact of an anti-sensitivity toothpaste on the oral-health-related quality of life (OHrQoL) in a real-world (RW) setting.
This was a decentralised, prospective, 24-week, open-label study in participants with self-reported dentine hypersensitivity (DH). A total of 655 enrolled participants used a 5% potassium nitrate toothpaste per label instructions and completed the Dentine Hypersensitivity Experience Questionnaire (DHEQ) and Numerical Pain Rating Scale (NPRS) monthly for 24 weeks and numerical scale for satisfaction of self-management of DH at 24 weeks. An ANOVA model was used to assess changes from baseline, overall and within subgroups (age ≤ 40, > 40 years, DH diagnosis confirmed or not by a dentist, use of sensitivity toothpaste [non-user, intermittent and current users] and DH frequency [frequent: several times a week; less frequent: less than once a week]).
The intent-to-treat population included 577 participants. At each timepoint, compared to baseline, improvements were statistically significant for all measures of OHrQoL (p < 0.0001, except Global Oral Health) and for NPRS (p < 0.0001) in the overall population and among subgroups (p < 0.05). All participants were highly satisfied with the product for self-management of DH.
This study showed the effectiveness of an anti-sensitivity toothpaste in improving OHrQoL and self-reported DH in an RW setting, as measured by a validated questionnaire.
评估一款抗敏感牙膏在真实环境中对口腔健康相关生活质量（OHrQoL）的影响。
这是一项针对自我报告有牙本质过敏（DH）的参与者进行的去中心化、前瞻性、为期24周的开放标签研究。总共655名入组参与者按照标签说明使用含5%硝酸钾的牙膏，并在24周内每月完成牙本质过敏体验问卷（DHEQ）和数字疼痛评分量表（NPRS），以及在24周时完成关于DH自我管理满意度的数字量表。使用方差分析模型评估与基线相比的变化，包括总体变化以及亚组内变化（年龄≤40岁、>40岁，是否经牙医确诊为DH，是否使用过敏感牙膏[非使用者、间歇性使用者和当前使用者]以及DH发作频率[频繁：每周数次；不频繁：每周少于一次]）。
意向性分析人群包括577名参与者。在每个时间点，与基线相比，总体人群以及各亚组中OHrQoL的所有测量指标（除全球口腔健康外，p<0.0001）和NPRS（p<0.0001）的改善均具有统计学意义（p<0.05）。所有参与者对该产品用于DH自我管理的满意度都很高。
本研究表明，通过一份经过验证的问卷测量，一款抗敏感牙膏在真实环境中对于改善OHrQoL和自我报告的DH是有效的。
