Abstract
BACKGROUND: Dentine hypersensitivity can impact functional status and everyday activities such as eating and talking. This study aimed to assess changes in oral health-related quality of life measures in individuals with dentine hypersensitivity following long-term use (24 weeks) of a commercially available toothpaste marketed for dentine hypersensitivity relief. METHODS: This study was conducted across two sites and enrolled 75 adults with ≥2 non-adjacent sensitive teeth. Participants were assigned to twice-daily brushing with toothpaste containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Every 4 weeks, participant-reported outcomes were assessed using the Dentine Hypersensitivity Experience Questionnaire (DHEQ), a condition specific oral health-related quality of life scale that has five domains and includes questions on social and emotional impact, restrictions, adaptations and effect on life overall. Responses to a clinically applied evaporative (air) stimulus were assessed using the examiner-observed Schiff sensitivity scale and Labelled Magnitude Scales (LMS), which included dentine hypersensitivity-specific descriptors of intensity, duration, tolerability and descriptive qualities of the participant's response. RESULTS: Participant-reported outcomes demonstrated reduction of the impact of dentine hypersensitivity over time on health-related quality of life, as measured by the DHEQ. This reached statistical significance from Week 8 onwards (p < 0.0001 versus baseline) for the Total DHEQ score, with scores continually decreasing at each timepoint. Most domain scores followed a similar pattern. Statistically significant reductions were also detected for the examiner-observed Schiff Sensitivity Scale scores at all timepoints (including at 4 weeks) (p < 0.05), which were mirrored by LMS responses. The toothpaste was generally well-tolerated. CONCLUSIONS: These results show that long-term use of a sensitivity toothpaste containing 0.454% w/w stannous fluoride has a beneficial, ongoing, impact on the oral health-related quality of life of people with dentine hypersensitivity. TRIAL REGISTRATION: This study was registered at Clinicaltrials.gov ( https://clinicaltrials.gov/ct2/show/NCT02752958 ) on April 27, 2016.