Randomized Trial Evaluating 0.454% Stannous Fluoride Dentifrice with Restorative Dentistry

Objective: A pilot clinical trial was conducted to evaluate the clinical response of 0.454% stannous fluoride dentifrice used during routine crown and bridge treatment. Methods: After informed consent, healthy adults undergoing crown and bridge treatment at the dental school were randomized to a therapeutic dentifrice or normal oral hygiene, which served as the untreated control. Test products were distributed blind to treatment at the preparation visit, with subjects receiving either 0.454% stannous fluoride sodium hexametaphosphate (Crest® Pro-Health™) or control. Subjects were instructed to brush normally (unsupervised) at least twice daily. Gingivitis and bleeding were measured at the preparation, impression and cementation visits using a standard clinical index (Loe-Silness). Treatments were compared using non-parametric ANCOVA. Results: 33 subjects with common gingivitis evaluators at all time points were included the analysis. Groups were balanced (p>0.33) on gingivitis and bleeding at baseline. At both the impression and cementation visits, the stannous fluoride dentifrice group had lower observed gingivitis and bleeding scores than control. In the crown preparation region, median gingivitis scores were 0.00 in the stannous fluoride group compared to 0.26 in the control, resulting into significantly lower gingivitis (p<0.01) and bleeding (p<0.05) with the therapeutic dentifrice at the impression visit. Outcomes were directionally similar at cementation, with median gingivitis scores of 0.11 in the stannous fluoride group and 0.33 in control. Treatment was generally well-tolerated. Conclusion: This pilot study supports use of 0.454% stannous fluoride dentifrice to reduce gingivitis and bleeding during crown and bridge treatment.