Erosion protection benefits of stabilized SnF2 dentifrice versus an arginine-sodium monofluorophosphate dentifrice: results from in vitro and in situ clinical studies.

OBJECTIVES: The aim of these investigations was to assess the ability of two fluoride dentifrices to protect against the initiation and progression of dental erosion using a predictive in vitro erosion cycling model and a human in situ erosion prevention clinical trial for verification of effectiveness. MATERIALS AND METHODS: A stabilized stannous fluoride (SnF2) dentifrice (0.454 % SnF2 + 0.077 % sodium fluoride [NaF]; total F = 1450 ppm F) [dentifrice A] and a sodium monofluorophosphate [SMFP]/arginine dentifrice (1.1 % SMFP + 1.5 % arginine; total F = 1450 ppm F) [dentifrice B] were tested in a 5-day in vitro erosion cycling model and a 10-day randomized, controlled, double-blind, two-treatment, four-period crossover in situ clinical trial. In each study, human enamel specimens were exposed to repetitive product treatments using a standardized dilution of test products followed by erosive acid challenges in a systematic fashion. RESULTS: Both studies demonstrated statistically significant differences between the two products, with dentifrice A providing significantly better enamel protection in each study. In vitro, dentifrice A provided a 75.8 % benefit over dentifrice B (p < 0.05, ANOVA), while after 10 days in the in situ model, dentifrice A provided 93.9 % greater protection versus dentifrice B (p < 0.0001, general linear mixed model). CONCLUSION: These results support the superiority of stabilized SnF2 dentifrices for protecting human teeth against the initiation and progression of dental erosion. CLINICAL RELEVANCE: Stabilized SnF2 dentifrices may provide more significant benefits to consumers than conventional fluoride dentifrices.

Erosion Prevention Potential of an Over-the-Counter Stabilized SnF2 Dentifrice Compared to 5000 ppm F Prescription-Strength Products.

OBJECTIVE: To determine the relative ability of various F-containing products to protect enamel against the initiation and progression of tooth surface loss due to erosive acid challenges. METHODS: Cores of enamel were prepared from extracted human teeth, soaked in pooled human saliva (pellicle formation), and then treated in a 1:3 slurry (product:saliva) of either OTC level (1100 ppm F) or prescription level (5000 ppm F) products, followed by a standardized erosion cycling procedure (five days of cycling) that included 10-minute challenges with an erosive dietary acid (1% citric acid at pH 2.3) applied 60 minutes after each dentifrice treatment (repeated four times per day). Enamel surface loss was measured using transverse microradiography. Two studies were conducted. Study 1 included: A) 1100 ppm F as NaF; B) 1100 ppm F as stabilized SnF; C) 5000 ppm F as NaF; and D) 5000 ppm F as NaF + acidulated phosphate. Study 2 included: 1) 1100 ppm F as stabilized SnF; 2) 5000 ppm F as NaF + tricalcium phosphate; and 3) 1100 ppm F as NaF. RESULTS: Study 1: Treatment B (1100 ppm F as SnF), where specimens lost only 8.0 µm of the enamel surface, was significantly more effective than Treatments A, C, and D at protecting enamel against the initiation and progression of erosive acid damage (p < 0.05). Specimens treated with product A exhibited 22.8 (1.25) µm (mean ± sem) of enamel loss; 20.0 (0.71) µm of enamel loss with treatment C and 24.0 (1.4) µm of enamel loss with Treatment D. Study 2 also demonstrated significantly greater erosion protection with the stabilized SnF2 dentifrice (p < 0.05), with only 5.8 (1.93) µm of tooth surface loss, while groups 2 and 3 lost 19.8 (0.75) µm and 18.0 (2.16) µm, respectively. CONCLUSION: Results from both studies demonstrated the OTC dentifrice formulated with stabilized SnF2 provides significantly greater protection against erosive acid attack compared to some of the most popular prescription level (5000 ppm F) fluoride treatments available.

A new model for demonstrating enamel protection benefits relative to acid challenge.

OBJECTIVE: To determine the applicability of a modified US FDA Caries Monograph test method for measuring the protective benefits of fluoride (F) against erosive, dietary acids. METHODS: Acid-challenged teeth were treated in two studies with a dentifrice, rinsed, and then re-challenged in a series of tests using three dietary acids. Study 1 included dentifrices containing 1450 ppm F as sodium fluoride (NaF) + triclosan [A], 1450 ppm F (NaF) + potassium nitrate (KNO3) [B], 1000 ppm F as sodium monofluorophosphate (SMFP) [C], and 0 ppm F (placebo) [D]. Study 2 included dentifrices containing 1450 ppm F (NaF) [A]; and 0 ppm F (placebo) [B]. Acids were analyzed for phosphate removed during tooth challenges, with post-treatment results compared to baseline. Results were averaged and reported as a % protection value for each product, with higher values indicating greater protection. RESULTS: Study 1: % protection for A = 16.4; B = 13.0; C = 7.1; and D = -5.2. Study 2: A = 15.2; B = -10.5, with A = B > C > D: Study 1; and A > B: Study 2. In each study, p < 0.05, ANOVA. CONCLUSIONS: The model provides a viable tool for initially assessing the potential for fluoride-containing oral care products to protect teeth against erosive, dietary acids. This can then lead to further and more elaborate testing with reasonable expectations for outcomes.

Enamel protection from acid challenge--benefits of marketed fluoride dentifrices.

OBJECTIVE: To determine the ability of various marketed dentifrices containing stabilized stannous fluoride (SnF2), sodium fluoride (NaF), or sodium monofluorophosphate (SMFP) to protect enamel against the earliest stages of erosive dietary acid damage using an in vitro enamel protection model. METHODS: Acid-challenged, extracted human teeth were treated with a 1:3 dilution of dentifrice, rinsed, and then challenged in a controlled series of tests using four dietary acids considered potentially erosive to teeth. Each acid was collected and analyzed to determine the level of mineral (phosphorous) removed from the teeth during the challenge. Post-treatment results were compared to baseline values for each acid. Results for the four acids were averaged and reported as an average percent protection value for each of the dentifrices tested, with higher values representing greater acid protection. The study included six dentifrices formulated with (A) sodium fluoride (NaF), (B) stabilized stannous fluoride (SnF2), (C,D) NaF plus 5% potassium nitrate (KNO3), (E) sodium monofluorophosphate (SMFP), or (F) SMFP plus 8% arginine bicarbonate. RESULTS: The stabilized SnF2 dentifrice demonstrated an average protection score of 39.3%, while products formulated with NaF resulted in protection scores between 11 and 13%. The SMFP dentifrice was rated at -3.5%, and the SMFP + arginine bicarbonate dentifrice resulted in a net average score of -5.0%. Results of this test were statistically significant (p < 0.05, ANOVA: B > A = C = D > E = F), in favor of the stabilized SnF2 dentifrice. CONCLUSIONS: These results suggest the stabilized SnF2 dentifrice has the potential to provide significantly better overall acid protection versus any of the other dentifrices included in the study.