Clinical oral investigations · 2026
Anhydrous stannous fluoride toothpaste in dentin hypersensitivity: clinician-assessed and patient-reported outcomes from two controlled trials.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Qiu Jianhong, Creeth Jonathan E, Mohammad Abeera, Milleman Kimberly R, Gallob John, Milleman Jeffery, Pradhan Monica, Qaqish Jimmy
Аннотация
OBJECTIVES: To confirm anti-sensitivity efficacy of a new anhydrous 0.454% stannous fluoride (SnF2) toothpaste formulation compared to a standard fluoride toothpaste after 28 and 56 days of twice-daily brushing, using clinician-assessed measures and patient-reported outcomes.
MATERIALS AND METHODS: Two independent, examiner-blind, parallel studies enrolled healthy adults with dentin hypersensitivity (DH). Participants were randomized to brush twice-daily with either the SnF₂ toothpaste (Test) or a standard fluoride toothpaste (Reference). DH was assessed by clinician via evaporative (Schiff scale) and tactile (Yeaple probe) stimuli. Participant-reported outcomes were measured using the Labelled Magnitude Scales (LMS) (for DH pain), and the DH Experience Questionnaire (DHEQ-48) (for impact on oral health-related quality-of-life).
RESULTS: 104 participants in Study 1 and 113 participants in Study 2 (18-65 years) were randomized. In both studies, the Test treatment showed a statistically significant decrease in Schiff sensitivity scores, an increase in tactile threshold, and an improvement in LMS domain scores from baseline to Day 28 and 56. The improvements in all three measures were greater than those observed for the Reference treatment (all, p < 0.05). Additionally, Study 1 showed significantly greater improvements in DHEQ scores in the Test treatment versus the Reference at Day 56. Toothpastes were generally well-tolerated.
CONCLUSIONS: Twice-daily use of the 0.454% SnF₂ toothpaste significantly and progressively reduced examiner-assessed and perceived DH over 56 days versus standard fluoride toothpaste.
CLINICAL RELEVANCE: The studies confirm the efficacy of the novel 0.454% SnF₂ toothpaste in delivering meaningful relief from DH, supporting its role as a patient-centred treatment.
MATERIALS AND METHODS: Two independent, examiner-blind, parallel studies enrolled healthy adults with dentin hypersensitivity (DH). Participants were randomized to brush twice-daily with either the SnF₂ toothpaste (Test) or a standard fluoride toothpaste (Reference). DH was assessed by clinician via evaporative (Schiff scale) and tactile (Yeaple probe) stimuli. Participant-reported outcomes were measured using the Labelled Magnitude Scales (LMS) (for DH pain), and the DH Experience Questionnaire (DHEQ-48) (for impact on oral health-related quality-of-life).
RESULTS: 104 participants in Study 1 and 113 participants in Study 2 (18-65 years) were randomized. In both studies, the Test treatment showed a statistically significant decrease in Schiff sensitivity scores, an increase in tactile threshold, and an improvement in LMS domain scores from baseline to Day 28 and 56. The improvements in all three measures were greater than those observed for the Reference treatment (all, p < 0.05). Additionally, Study 1 showed significantly greater improvements in DHEQ scores in the Test treatment versus the Reference at Day 56. Toothpastes were generally well-tolerated.
CONCLUSIONS: Twice-daily use of the 0.454% SnF₂ toothpaste significantly and progressively reduced examiner-assessed and perceived DH over 56 days versus standard fluoride toothpaste.
CLINICAL RELEVANCE: The studies confirm the efficacy of the novel 0.454% SnF₂ toothpaste in delivering meaningful relief from DH, supporting its role as a patient-centred treatment.