Clinical Study to Assess the Efficacy of New Toothpaste Containing SnF as Compared to Colgate Cavity Protection Toothpaste on the Reduction of Enamel Erosion

The objective of this clinical study is to assess the efficacy of New Toothpaste Containing SnF as compared to commercially available toothpaste in the reduction of enamel erosion over a ten (10) days period. This investigation will be a randomized, double-blinded, single-center, parallel clinical study. Subjects will be randomly assigned to one of the two study groups, and will be instructed to use their assigned toothpaste for a period of ten (10) days.

Inclusion criteria

• Sign an Informed Consent Form;
• Male or female 18 to 70 years of age, inclusive;
• Be in good general health as determined by the study investigators;
• Available for the eighteen (18) days duration of the study;
• Have normal salivary flow rate (stimulated and unstimulated flow of ≥0.7 ml/min and ≥0.2 ml/min respectively) ascertained from a preliminary saliva examination;
• Have healthy salivary pH (unstimulated saliva pH 6.8-7.8) ascertained from a preliminary saliva test;
• Must be able to accept a well-fitting removable intraoral appliance bearing at least two enamel specimens.

Exclusion criteria

• Gross oral pathology, chronic disease, and/or history of allergies to any of the test products;
• Use of a desensitizing oral care product and/or recipient of any dental desensitizing treatment within the past three months prior to start of the study;
• Advanced periodontal disease and/or treatment for periodontal disease (including surgery) within the past twelve months;
• Obvious signs of dental erosion Teeth with extensive/defective restorations (including prosthetic crowns), suspected pulpitis, caries, cracked enamel, or used as abutments for removable partial dentures;
• Current use of anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs, daily use of analgesics, or medication which alters salivary flow
• Participation in any other oral clinical study for the duration of this study
• Self-reported pregnancy and/or currently breastfeeding;
• Allergies to oral care products, personal care consumer products, and/or their ingredients;
• Medical condition which prohibits not eating/drinking for 4 hours.