AIM: To compare the anticalculus efficacy of an experimental dentifrice (0.454% stabilized stannous fluoride/sodium hexametaphosphate) with a negative control. METHODS AND MATERIALS: This was a randomized, examiner-blind, parallel group study. After a three-month run-in, qualifying subjects were randomized to the experimental or control dentifrice to use twice a day for six months. Volpe-Manhold Index (V-MI) and oral soft tissue examinations were conducted at baseline, three, and six months. Additional analyses were performed separately at three and six months on three subgroups categorized into high, medium, and low calculus-forming subjects. RESULTS: Compared to the control group, the experimental dentifrice group had a mean calculus score statistically significantly lower at both three months (50%) and six months (55%) post-treatment (p<0.001). Compared to control scores, mean experimental dentifrice calculus scores at three and six months were statistically significantly lower at both points in time for high, medium, and low calculus forming sub-groups (p<0.001). Both products were generally well tolerated. CONCLUSION: The experimental dentifrice revealed significant anticalculus efficacy compared to the control regardless of levels of baseline calculus formation. CLINICAL SIGNIFICANCE: The stannous fluoride/sodium hexametaphosphate dentifrice technology is an effective calculus inhibitor for home care.
RCT Entities:
AIM: To compare the anticalculus efficacy of an experimental dentifrice (0.454% stabilized stannous fluoride/sodium hexametaphosphate) with a negative control. METHODS AND MATERIALS: This was a randomized, examiner-blind, parallel group study. After a three-month run-in, qualifying subjects were randomized to the experimental or control dentifrice to use twice a day for six months. Volpe-Manhold Index (V-MI) and oral soft tissue examinations were conducted at baseline, three, and six months. Additional analyses were performed separately at three and six months on three subgroups categorized into high, medium, and low calculus-forming subjects. RESULTS: Compared to the control group, the experimental dentifrice group had a mean calculus score statistically significantly lower at both three months (50%) and six months (55%) post-treatment (p<0.001). Compared to control scores, mean experimental dentifrice calculus scores at three and six months were statistically significantly lower at both points in time for high, medium, and low calculus forming sub-groups (p<0.001). Both products were generally well tolerated. CONCLUSION: The experimental dentifrice revealed significant anticalculus efficacy compared to the control regardless of levels of baseline calculus formation. CLINICAL SIGNIFICANCE: The stannous fluoride/sodium hexametaphosphate dentifrice technology is an effective calculus inhibitor for home care.
Authors: Philip G Bellamy; Robin Harris; Robert F Date; Andrew J S Mussett; Andrew Manley; Andrew Manly; Matthew L Barker; Nicola Hellin; Nicola X West Journal: Int Dent J Date: 2014-03 Impact factor: 2.607