A Real-World Evidence Study Evaluating Oral-Health-Related Quality of Life Following the Use of Anti-Sensitivity Toothpaste for Self-Reported Dentine Hypersensitivity Management

AimsTo evaluate the impact of an anti-sensitivity toothpaste on the oral-health-related quality of life (OHrQoL) in a real-world (RW) setting. Materials and MethodsThis 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]). ResultsThe 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. ConclusionsThis 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.