The comparative efficacy of stabilized stannous fluoride dentifrice, peroxide/baking soda dentifrice and essential oil mouthrinse for the prevention of gingivitis.

This double-blind parallel-design clinical study compared the efficacy of a stabilized stannous fluoride dentifrice (Crest Plus Gum Care), baking soda and peroxide (NaF) dentifrice (Mentadent), and essential oil mouthrinse (Listerine) to a conventional NaF dentifrice (Crest) for the control of plaque, gingivitis and gingival bleeding over six months. Following an initial baseline examination and stratification, subjects received a complete oral prophylaxis and were distributed assigned test products. Following three and six months, subjects re-visited the clinic for examinations. Evaluations at baseline and at 3 and 6 months included soft tissue status. Löe-Silness gingivitis/gingival bleeding, Silness-Löe plaque and dental stain. Results subsequent to six months of product use were as follows: At six months, the stabilized stannous fluoride dentifrice was observed to produce statistically significant 17.5% reductions in gingivitis and 27.5% reductions in gingival bleeding relative to the NaF dentifrice. The combination of sodium fluoride dentifrice and essential oil mouthrinse produced statistically significant reductions of 7.4% in gingivitis and 10.8% in plaque as compared with the NaF dentifrice. The stabilized stannous fluoride dentifrice produced statistically significant reductions in both gingivitis (10.8%) and gingival bleeding (23.0%) relative to the combination of sodium fluoride dentifrice and essential oil mouthrinse. The baking soda and peroxide (NaF) dentifrice did not provide reductions in gingivitis, plaque or gingival bleeding as compared with the conventional NaF dentifrice. The stabilized stannous fluoride dentifrice provided statistically significant reductions in gingivitis as compared with the baking soda and peroxide dentifrice following six months of use, and both the essential oil mouthrinse and stabilized stannous fluoride dentifrice provided statistically significant reductions in gingivitis as compared with the baking soda and peroxide dentifrice following three months of use. These results support: 1) the efficacy of stabilized stannous fluoride dentifrice and the combination of sodium fluoride dentifrice and essential oil mouthrinse for the prevention of gingivitis; 2) the superior activity of stabilized stannous fluoride dentifrice as compared with a combination of sodium fluoride dentifrice and essential oil mouthrinse for the control of gingivitis and gingival bleeding; and 3) the lack of efficacy for baking soda and peroxide dentifrice for the control of plaque, gingivitis and gingival bleeding as compared with conventional fluoridated dentifrice.

A comparison of intraoral antimicrobial effects of stabilized stannous fluoride dentifrice, baking soda/peroxide dentifrice, conventional NaF dentifrice and essential oil mouthrinse.

The intraoral antimicrobial activity of four commercial oral products-conventional NaF dentifrice (Crest), baking soda/peroxide/NaF dentifrice (Mentadent), essential oil mouthrinse (Listerine) and SnF2 dentifrice (Crest Plus Gum Care)-have been compared in three test regimens. Formulations were compared for their ability to suppress the regrowth and apical extension of dental plaque following toothbrushing during thirty hours of non-brushing where products were used as oral rinses (30-hour plaque regrowth model). Formulations were also compared for their ability to suppress the colony-forming units (cfu) of facultative anaerobic bacteria sampled from buccal gingival surfaces following use (Gingival Surface Microbial Index-GSMI model). Lastly, formulations were compared for effects in suppressing the glycolytic metabolic activity and regrowth activity of in vivo-treated dental plaques sampled at various periods following topical use and incubated under controlled ex vivo conditions (Plaque Glycolysis and Regrowth-PGRM model). In thirty-hour plaque regrowth testing, the rank ordered antimicrobial efficacy of formulations followed SnF2 > essential oils > NaF = water = baking soda/peroxide. In GSMI testing, all formulations were shown to suppress the cfu of facultative anaerobic bacteria relative to baseline, although SnF2 treatment was observed to reduce bacterial levels to a significantly greater degree than NaF dentifrice or baking soda/peroxide dentifrice up to two hours following brushing. In PGRM testing, the SnF2 dentifrice provided significant inhibition of bacterial metabolism and regrowth following topical application when compared with the NaF dentifrice as control. The baking soda/peroxide dentifrice provided no reduction in either bacterial metabolism or regrowth in PGRM. Previous studies had demonstrated modest effects for essential oil rinse in reducing PGRM plaque regrowth, with no effects for this treatment on plaque metabolism. Overall, these results demonstrate that SnF2 dentifrice provides substantial intraoral antimicrobial effects. The essential oil mouthrinse also exhibits significant intraoral antimicrobial effects, albeit apparently less than SnF2 dentifrice. The baking soda/peroxide dentifrice did not produce any antimicrobial effects following in vivo use compared with conventional dentifrice. These results provide mechanistic rationale for the chemotherapeutic efficacy of SnF2 and essential oil formulations in reducing gingivitis, while providing no support for the expectation of clinical efficacy for formulations containing baking soda and peroxide.

Evaluation of Cetylpyridinium Chloride-Containing Mouthwashes Using In Vitro Disk Retention and Ex Vivo Plaque Glycolysis Methods.

The Disk Retention Assay (DRA) is an in vitro method developed to measure the available level of cetylpyridinium chloride (CPC) in mouthwash formulations. This method is based on the binding of the cationic CPC molecule to the anionic surface of a cellulose filter disk. Aqueous CPC solutions demonstrate a linear response (A545) for concentrations up to 0.3%. Higher levels of CPC showed no increased response in the assay. Among common oral product ingredients, at relevant concentrations, surfactants are the primary compounds which inhibit CPC detection and hence, chemical availability. Poloxamer-407 decreased CPC availability to 60% at 0.1%, to 10% at 0.5%, and to 24-33% for 0.2-0.4%. Polysorbate-80 decreased CPC availability to 30% at 0.1% and 6% at 0.25%. A range (4-54%) of available levels of CPC were determined for several commercial products containing 0.045-0.05% nominal levels of CPC indicating significant formulation excipient influence. A plaque glycolysis (PG) assay was used to determine the biological activity of all mouthwash products analyzed by DRA. An experimental series of mouthwash formulations having nominal CPC levels of 0-0.10% demonstrated a good correlation (r2 = 0.955) between the calculated available level of CPC (DRA) and inhibition of plaque glycolysis. The calculated available level of CPC from select commercial mouthwash products, also fit the established correlation with biological activity. The combination of DRA and plaque glycolysis methods are valuable tools which can be used during development to maximize the biological activity of CPC mouthwash formulations prior to clinical evaluation.

The clinical effect of a stabilized stannous fluoride dentifrice on plaque formation, gingivitis and gingival bleeding: a six-month study.

The effects of a stabilized 0.454% stannous fluoride dentifrice, currently marketed as Crest Gum Care, on supragingival plaque, gingivitis, gingival bleeding and oral soft tissue condition were studied in 328 adult male and female subjects who completed a six-month, double blind clinical study. Following initial examinations, subjects presenting with a minimum of five gingival bleeding sites received a thorough dental prophylaxis and were instructed to brush at least twice a day for three months with a commercially available fluoride dentifrice, packaged in such a way as to blind its identity to the study subjects. This constituted the three-month pre-test period. At the end of this period, subjects were again examined, given a second oral prophylaxis, and randomly assigned to brush with one of the following dentifrices: 1) stabilized 0.454% stannous fluoride, 2) 0.243% sodium fluoride control, or 3) one of three experimental dentifrices. Subjects were instructed to brush their teeth as they normally would, at least twice a day for one minute per brushing. Follow-up examinations after three and six months of dentifrice use evaluated supragingival plaque, gingivitis, gingival bleeding, extrinsic tooth stain and oral soft tissue status. After six months, the stabilized stannous fluoride dentifrice significantly reduced gingivitis and gingival bleeding by 20.5% and 33.4% compared to the sodium fluoride control group. However, the stabilized stannous fluoride dentifrice group was not significantly different from the control dentifrice group with respect to supragingival plaque scores. As expected, accumulation of extrinsic tooth stain was greater in the stabilized stannous fluoride group than the control group. No unexpected nor clinically significant oral soft tissue health effects were associated with the use of the test dentifrices. The results from this clinical study demonstrate that over a six-month period, twice-daily use of a dentifrice containing 0.454% stabilized stannous fluoride significantly reduced gingivitis and gingival bleeding, relative to a 0.243% sodium fluoride control dentifrice.