Comparison of a dual-phase fluoride toothpaste containing calcium, phosphate, and sodium bicarbonate with a regular fluoride toothpaste on calculus formation.

This clinical study compared the effect on dental calculus formation of a dual-phase fluoride dentifrice containing sodium bicarbonate, calcium, and phosphate with that of a regular dentifrice using a short-term clinical model in which calculus formation was facilitated. A total of 87 adult volunteers completed this study, which was a double-blind, parallel-group design, consisting of 2-week pretrial and trial periods separated by a washout period. A partial-mouth technique was used wherein the lower anterior teeth were protected from brushing by a custom-fitted toothshield, which doubled as an applicator for an undiluted dentifrice, twice daily. Calculus was measured on the labial/lingual surfaces of six lower anterior teeth by the Volpe-Manhold Index (V-MI). Subjects used a non-tartar-control dentifrice during the pretrial period to determine calculus formation rates, and these V-MI scores were used as baseline data for random allocation to either a control or test product for the trial period. Subjects who were accepted into the study, based on existing tartar deposits, readily formed calculus during the pretrial period using the toothshield method. During the trial period, subjects who were assigned the test dentifrice had comparable amounts of calculus accumulation to those who used the control dentifrice. However, subjects in the test dentifrice group had significantly lower (16%) calculus scores on lingual surfaces than those in the control group. Intragroup comparisons of V-MI data from the pretrial period with those from the trial period provided similar overall results to the comparisons between groups. This study demonstrated that a dual-phase baking soda dentifrice containing calcium and phosphate did not increase calculus accumulation relative to a regular dentifrice when used by adults with a propensity for developing calculus.

RCT Entities:   Population Interventions Outcomes