Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.

A Randomized, Single-center, Two-cell, Double-blind and Parallel-group Design Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a Test Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.

To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period.

Inclusion Criteria:

• Subjects were required to sign an Informed Consent form
• Subjects had to be in general good health
• Male and female adults between the ages of 18-70 (inclusive)
• Six (6) scoreable mandibular anterior teeth free of large restorations or dental prosthetic crowns
• Subjects were required to possess a Volpe-Manhold Calculus Index of at least 7.0
• Subjects had to be able to participate for the full duration (20 weeks) of the study

Exclusion Criteria:

• Presence of orthodontic appliances or removable prosthesis at the lower jaw or more than one mandibular anterior tooth with a prosthetic crown or veneer
• Tumor(s) or significant pathology of the soft or hard tissues of the oral cavity
• Moderate or advanced periodontal disease
• Five or more carious lesions requiring immediate care
• Use of antibiotics or steroids any time during one month prior to entry into the study
• Participation in any other clinical study or panel test
• Pregnant or breast feeding women
• History of allergies to dentifrice and personal care ingredients
• Allergies to dentifrice products
• Medical reasons that prohibit eating or drinking for 4 hours prior to clinical facility visit.