Development of an in situ methodology for the clinical evaluation of dentine hypersensitivity occlusion ingredients.

The aim of these clinical studies was to evaluate an in situ dentine tubule occlusion model, and to determine the occluding effect from novel occluding agents on patent dentine tubules compared to a positive control (8% strontium acetate--Sensodyne Mint) and negative control (a non-occluding agent) after four days of brushing treatment. These two in situ clinical studies were of single-center, randomized, crossover, single-blind design. Healthy participants wore two lower intra-oral appliances retaining four dentine samples for four treatment days for each period of the study. Samples were power-brushed each day with the test product. Assessment utilized surface topological analysis with a replica-based methodology under scanning electron microscopy (SEM). Both clinical trials demonstrated that the positive control (8% strontium acetate) occluded dentine tubules significantly better (p = 0.0007; p < 0.0009) than the negative controls in the two studies, respectively. The experimental occluding agents demonstrated varying degrees of success for occluding effect compared to the controls. The methodology clearly demonstrates that this in situ clinical model can robustly and reproducibly detect the dentine tubular occlusive effects of positive and negative controls in the treatment of dentine hypersensitivity brushed on the dentine surface. Using this methodology, new occlusion agents for the relief of dentine hypersensitivity can be assessed for occlusive effects on dentine.