A comparison of stabilized stannous fluoride dentifrice and triclosan/copolymer dentifrice for efficacy in the reduction of gingivitis and gingival bleeding: six-month clinical results.

This parallel-group, double-blind, placebo-controlled clinical trial directly compared the efficacy of two antimicrobial dentifrice formulations for the control of plaque, gingivitis and gingival bleeding during six months of use following a pre-test randomization period. Test antimicrobial dentifrices for the study included: a stabilized stannous fluoride formulation (Crest Plus Gum Care-currently marketed in U.S.) comprised of 0.454% SnF2 in a stabilized silica abrasive base; and a formulation containing triclosan (Colgate Total, currently marketed outside the U.S. in numerous countries) comprised of 0.30% triclosan. 2.0% Gantrez co-polymer and 0.243% NaF in a silica abrasive base. The control dentifrice was a conventional fluoride dentifrice comprised of 0.243% NaF in a silica abrasive base. Clinical evaluations included Turesky et al. plaque, Löe-Silness gingivitis and gingival bleeding, and Meckel stain. The stabilized stannous fluoride dentifrice exhibited significant efficacy in the reduction of both gingivitis (20.5%) and gingival bleeding (33.4%) after six months relative to the placebo control (p < 0.05). In direct comparison, the stabilized stannous fluoride dentifrice reduced gingivitis and gingival bleeding significantly relative to the triclosan/copolymer dentifrice (p < 0.05). These results establish: 1) the superior clinical efficacy of a stabilized stannous fluoride dentifrice relative to a triclosan/copolymer dentifrice in the chemotherapeutic control of gingivitis and gingival bleeding; 2) the important contribution of clinical test design/sensitivity in assessing the therapeutic efficacy of antimicrobial agents; and 3) the value of head-to-head comparative studies in establishing the therapeutic relevance of clinical effects of formulations for the reduction of gingivitis.

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.

A Quanticalc clinical comparison of professional efficiency in manual supragingival calculus debridement.

The Quanticalc (QC) dental scaler permits the assessment of work effort expended by professionals in removing supragingival calculus from the teeth. The purpose of this study was to compare the efficiency of two professionals in scaling calculus under controlled clinical conditions in like populations. One-hundred and thirty-one subjects were randomly assigned to two professionals, A and B, for QC scaling of their six Volpe-Manhold Index (VMI) teeth. VMI assessments were carried out by a separate examiner prior to QC cleaning. The QC was used to record total developed force, total strokes and force/stroke used in calculus debridement. Results demonstrated significant differences in scaling efficiency between the two professionals. These results further demonstrate the potential utility of the QC and like devices in assisting in the instruction of professionals toward the development of more efficient manual scaling procedures.

The comparative efficacy of two commercial tartar control dentifrices in preventing calculus development and facilitating easier dental cleanings.

Tartar control dentifrices have been proven effective in reducing the build-up of supragingival calculus deposits between professional tooth cleanings. In addition to providing consumers with a cleaner dentition, these formulations can, in principle, contribute to easier professional tooth cleaning. Until recently, clinical methods for evaluating the effects of tartar control dentifrices were limited to the assessment of area coverage of calculus on the tooth surface. The development of the Quanticalc dental scaler permits the quantitative clinical measurement of force and stroke number associated with supragingival calculus debridement. In this clinical study, two commercial tartar control dentifrices, one containing 5.0% pyrophosphate as the tartar control agent and the other containing a combination of 1.3% pyrophosphate and 1.5% Gantrez copolymer, were compared for efficacy in reducing the development of supragingival calculus between prophylaxes, and in facilitating easier calculus removal in subsequent scaling. Results showed that the two commercial dentifrices were equally effective in reducing calculus extent between prophylaxes. In contrast, the 5.0% pyrophosphate dentifrice was observed to be almost twice as effective on a percentage basis as the lower dosage pyrophosphate dentifrice in facilitating easier calculus removal. The enhanced activity of the 5.0% pyrophosphate dentifrice may be postulated to be due to elevated dosage of tartar control crystallization inhibitor or to potential side effects of copolymer in the other commercial dentifrice. Importantly, these results substantiate that the clinical benefits of tartar control dentifrices are not completely described by actions in reducing calculus build-up as assessed by VMI, and that important clinical benefits and differences in efficacy may be provided by these formulations in facilitating easier dental cleaning of supragingival calculus.

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.

A new Plaque Glycolysis and Regrowth Method (PGRM) for the in vivo determination of antimicrobial dentifrice/rinse efficacy towards the inhibition of plaque growth and metabolism--method development, validation and initial activity screens.

A new method, the Plaque Glycolysis and Regrowth Method (PGRM), is described for the evaluation of antimicrobial effects on plaque metabolism in vivo. The method relies on the experimental observation that in vivo sampled dental plaques, collected from different quadrants of the dentition, produce equivalent rates of metabolic activity and regrowth when similarly dispersed and normalized into incubation media. In applications of the technique to antimicrobial evaluations, overnight fasted dental plaque is collected from a non-treated quadrant of the dentition along the gingival margin. Topical formulations are used in vivo. Following this, dental plaques are collected from other dentition quadrants at extended times, allowing for the back diffusion, clearance and natural intraoral deactivation of antimicrobials within the oral cavity. In vivo treated and non-treated plaque samples are subsequently tested for metabolic and regrowth activity under controlled and standardized conditions in vitro following normalization for biomass. The technique thus combines the necessary biological factors important to the legitimate evaluation of antimicrobial effects in vivo, while benefiting from the improved precision and control provided by in vitro assessment of plaque activity. In this paper evidence is presented validating the PGRM method, and initial activity screens of commercial antimicrobial mouthrinses and toothpastes, including a new stabilized stannous fluoride dentifrice, are described.

Effects of nine weeks' use of a new stabilized stannous fluoride dentifrice on intrinsic plaque virulence expressed as acidogenicity and regrowth: a modified PGRM study.

A new stabilized stannous fluoride dentifrice, currently marketed as Crest Gum Care has been examined for its effects on intrinsic plaque metabolic and regrowth activity and effects on plaque resistance to SnF2 throughout nine weeks of toothbrushing. Subjects brushed their teeth 1 X, 2 X or 3 X/day with stabilized stannous fluoride dentifrice or placebo dentifrice for nine weeks, presenting in the morning on weeks 3, 6-9 for plaque sampling. Following nine weeks, subjects were crossed-over and repeated the experiment on their alternative assigned product (active SnF2/placebo). Sampled dental plaques were evaluated for standardized glycolysis and regrowth activity using the "Plaque Glycolysis and Regrowth Method" (PGRM). Following the second nine-week treatment period, subjects concluding either placebo or SnF2 toothbrushing participated in a single-treatment PGRM experiment using stabilized stannous fluoride dentifrice. Toothbrushing with stabilized stannous fluoride dentifrice in this experiment produced significant and sustained reductions in both plaque glycolytic and regrowth activity as compared to placebo treated plaques. In the concluding single-brushing PGRM experiment, SnF2 dentifrice was shown to produce equal inhibitory actions in plaque from subjects completing stannous fluoride or placebo treatments. This result confirmed that nine weeks toothbrushing with stabilized stannous fluoride dentifrice produced no development or resistance of plaque to SnF2 inhibition. These results support the strong in vivo antimicrobial actions of the stabilized stannous fluoride dentifrice, Crest Gum Care.