Impact of a Desensitising Toothpaste on Quality of Life: RWE

Objectives: To evaluate the impact of a commercially available toothpaste containing 5% potassium nitrate on oral health related quality of life (OHrQoL) in a real-world (RW) setting.
Methods: Fully decentralised, prospective, 24-week, open-label study in healthy subjects, aged 18-65 years, with self-reported dentine hypersensitivity (DH). A total of 655 subjects were recruited through social media platforms. Subjects used Sensodyne Fresh Mint toothpaste as per commercial tube instructions and complete a validated OHrQoL questionnaire (Dentine Hypersensitivity Experience Questionnaire, DHEQ) at baseline, 4, 8, 12, 16, 20 and 24 weeks. An ANOVA model was used to assess changes from baseline, overall and within subgroups. Subgroup analyses included 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: ≤once a week).
Results: A total of 557 subjects completed the study. Statistically significant improvements (p<0.0001) in OHrQoL were observed in the overall population at each timepoint vs baseline for DHEQ total score, domains (restriction, emotional impact, adaption, social impact and identity), Global Oral Health and Effect on Life overall. Data demonstrated statistically significant improvement from baseline (p<0.0001) on everyday life: symptoms were less intense (-2.94), better tolerated (-2.37), and subjects were less bothered by DH (-3.24). Similar trend of improvements was observed amongst subgroups (p<0.05). Forty-four subjects reported treatment emergent adverse events (TEAEs), 7 reported 10 oral TEAEs; only one was considered treatment related (lip dryness).
Conclusions: This fully decentralised study demonstrated the effectiveness of 5% potassium nitrate toothpaste in improving OHrQoL of self-reported DH sufferers over 24 weeks in RW setting: less impact on daily life activities and emotions, fewer modifications to habits, less difficulties to be with others and less negative impact on health or age perception. Treatment was well tolerated.