A clinical study to measure anti‐erosion properties of a stabilized stannous fluoride dentifrice relative to a sodium fluoride/triclosan dentifrice

Abstract

Objective To compare the enamel protection efficacy of a stabilized stannous fluoride (SnF2) dentifrice to a sodium fluoride (NaF)/triclosan dentifrice following acidic erosive challenge. Methods In this in situ, randomized, controlled, double‐blind, two‐treatment, four‐period crossover clinical trial, subjects wore an appliance fitted with human enamel samples 6 h day−1 during each 15‐day treatment period. Twice each treatment day they swished with their assigned dentifrice slurry: 0.454% SnF2/0.077% NaF or 0.32% NaF/0.3% triclosan. After each treatment and two other times daily, subjects swished with 250 ml of orange juice over a 10‐min period (acidic erosive challenge). Enamel samples were measured for tooth surface loss using contact profilometry at baseline and days 10 and 15. Results Thirty‐six subjects (mean age 44.8 years, range 23–65 years) were randomized to treatment; 33 subjects completed the final study visit. There were no statistically significant baseline differences (P > 0.44) in the specimen surfaces of the two dentifrice treatment groups via profilometry. At day 10, the SnF2 dentifrice provided a statistically significant (P < 0.0001) reduction in enamel loss by 67% versus the NaF/triclosan dentifrice with estimated medians of 1.22 and 3.68 μm, respectively. At day 15, the SnF2 dentifrice again provided a significantly greater benefit (P < 0.0001) against tooth surface loss versus the NaF/triclosan dentifrice, with 68% less erosion, and estimated medians of 1.60 and 5.03 μm, respectively. Both dentifrices were well tolerated. Conclusion A stabilized SnF2 dentifrice provided superior protection against the initiation and progression of tooth enamel surface loss in situ after erosive challenge compared to a NaF/triclosan dentifrice.

Randomized in situ clinical trial evaluating erosion protection efficacy of a 0.454% stannous fluoride dentifrice

“…This study, using 10‐day treatment periods, demonstrated a significant erosion protection benefit of 93.5% for the multi‐benefit, 1100 ppm fluoride, high bioavailable stabilized stannous fluoride dentifrice compared to the triclosan‐containing dentifrice formulated with 1100 ppm fluoride as NaF. These results are consistent with other in situ clinical studies in the literature that have similarly demonstrated enhanced erosion protection, ranging from 27% to 94%, delivered from stabilized stannous fluoride dentifrices compared to other dentifrices that are not formulated with this ingredient . For example, a similar study by West et al found 68% greater erosion protection for a 0.454% stannous fluoride plus 0.077% sodium fluoride (1450 ppm fluoride) dentifrice marketed in the United Kingdom compared to a 1450 ppm fluoride NaF/triclosan dentifrice after 15 days of treatment and a 67% benefit after 10 treatment days.…”

“…These results are consistent with other in situ clinical studies in the literature that have similarly demonstrated enhanced erosion protection, ranging from 27% to 94%, delivered from stabilized stannous fluoride dentifrices compared to other dentifrices that are not formulated with this ingredient. [19][20][21][22][23][24] For example, a similar study by West et al 19 found 68% greater erosion protection for a 0.454% stannous fluoride plus 0.077% sodium fluoride (1450 ppm fluoride) dentifrice marketed in the United Kingdom compared to a 1450 ppm fluoride NaF/triclosan dentifrice after 15 days of treatment and a 67% benefit after 10 treatment days. These study results are also consistent with recommendations from professional groups and organizations.…”

“…While some fluoride sources have been shown to provide a limited level of erosion protection, stannous fluoride, a multi‐benefit active used in some toothpastes, has been shown to provide significant anti‐erosion benefits in various types of laboratory studies . There is a growing body of in situ evidence to support the claim that the use of stabilized stannous fluoride dentifrice is an effective means to help control both the initiation and progression of dental erosion in vivo …”

“…[15][16][17][18] There is a growing body of in situ evidence to support the claim that the use of stabilized stannous fluoride dentifrice is an effective means to help control both the initiation and progression of dental erosion in vivo. [19][20][21][22][23][24] The study reported here was the first to evaluate a high bioavailable 1100 ppm fluoride stabilized stannous fluoride dentifrice relative to a marketed 1100 ppm fluoride triclosan dentifrice control for erosion protection efficacy using an in situ erosion model with 10-day treatment periods.…”

Influence of cigarette smoke combined with different toothpastes on enamel erosion

“…9 Therefore, it is necessary to combine fluoride with other agents. 7 In this study, NaF had more anti-erosive effects only in relation to the negative control treated to distilled water, as previously reported 28 . Under acidic conditions, the NaF action of forming a CaF 2 layer on demineralized surfaces is reduced at low pH 9 .…”