Relative anti-caries efficacy of 1100, 1700, 2200, and 2800 ppm fluoride ion in a sodium fluoride dentifrice over 1 year.

There is limited evidence from clinical trials on the dose response of sodium fluoride dentifrices at concentrations above 1100 ppm fluoride ion, with respect to caries efficacy. This randomized, double-blind study examined the anti-caries effectiveness of sodium fluoride dentifrices containing 1700 ppm, 2200 ppm and 2800 ppm fluoride ion relative to an 1100 ppm fluoride ion control. A population of 5439 elementary schoolchildren, aged 6-15 years, was recruited from an urban central Ohio area with a low fluoride content water supply (<0.3 ppm). Subjects were examined by visual-tactile and radiographic examination at baseline and after 1, 2, and 3 years of using the sodium fluoride dentifrices. Subjects were stratified according to gender, age and baseline DMFS scores derived from the visual-tactile baseline examination and randomly assigned to one of four treatment groups: 0.243% sodium fluoride (1100 ppm fluoride ion), 0.376% sodium fluoride (1700 ppm fluoride ion), 0.486% sodium fluoride (2200 ppm fluoride ion), and 0.619% sodium fluoride (2800 ppm fluoride ion). All products were formulated with the same fluoride compatible silica abrasive. Results after 1 year provided evidence of a positive sodium fluoride dose response. Compared to the 1100 ppm fluoride treatment group, the 1700 ppm fluoride treatment group had an 11.0% reduction in DMFS that was not statistically significant, while the 2200 ppm and 2800 ppm fluoride treatment groups showed statistically significant (P<0.05) reductions of 18.6% and 20.4%, respectively. The reductions in caries delivered by the higher fluoride dentifrices were present across all tooth surface types, but were most pronounced for occlusal surfaces. Results at years 2 and 3 were confounded by a concurrent fluoride rinse program, which involved portions of the study population. While the trends for the higher fluoride dentifrices observed at year 1 remained at years 2 and 3, the difference observed between treatments were substantially less and failed to reach statistical significance (P<0.05). Collectively, the data demonstrate that the 2200 ppm and the 2800 ppm fluoride treatments delivered statistically significantly greater caries efficacy than the 1100 ppm fluoride treatment. This large-scale clinical trial provides evidence of a positive statistically significant dose relationship between dental caries and sodium fluoride in a dentifrice at levels above 1100 ppm fluoride at year 1.

Reduction in dental caries with four concentrations of sodium fluoride in a dentifrice: a meta-analysis evaluation.

Information on the effects of fluoride concentrations above 1,100 ppm in dentifrices is not extensive in the literature. The objective of this meta-analysis was to examine and compare the anticaries effectiveness (in terms of DMFS scores) of 1,700 ppm, 2,200 ppm and 2,800 ppm F- ion (as sodium fluoride) dentifrices vs. an 1,100 ppm F- ion (as sodium fluoride) control dentifrice based on results from six double-blind, randomized clinical studies, each conducted over a two- to three-year period. The studies each enrolled approximately 1,200-2,000 male and female school children per treatment group in grades I through 8, and were conducted in areas with low fluoride content water supplies in the states of Indiana, Pennsylvania, Ohio and Oregon. Separate meta-analyses were performed on the study results (DMFS increment scores determined by visual-tactile examinations supplemented with radiographs) for the one-year, two-year and three-year examinations. Comparisons of the 1,700 ppm F-, 2,200 ppm F-, and 2,800 ppm F- groups vs. the 1,100 ppm F- group were based on pooling the effect sizes for these comparisons from the individual studies. The effect sizes were calculated in two different ways, reflecting the analyses that were performed in the original studies: 1) effects based on the sample means and variances; and 2) effects based on the adjusted sample means and mean squared error from an analysis of covariance. The results obtained from this meta-analysis provide evidence that the use of a 2,800 ppm F- ion, as sodium fluoride, dentifrice results in statistically significantly lower caries increment than the use of an 1,100 ppm F- ion, as sodium fluoride, dentifrice. This result was noted after one, two, and three years of dentifrice use. The 1,700 ppm F- and 2,200 ppm F- dentifrice groups showed some directional advantages over the 1,100 ppm F- dentifrice group, however the analysis did not establish these groups as statistically significantly better than 1,100 ppm F-. The meta-analysis based on analysis of covariance results was somewhat more sensitive to treatment group differences than the analysis based on sample means and variances, as was expected.

Plaque regrowth effects of a triclosan/pyrophosphate dentifrice in a 4-day non-brushing model.

Triclosan is a lipophilic antimicrobial agent which, when present in an aqueous dentifrice vehicle, is complexed by or in close contact with polymers and surface-active molecules, emulsifying agents, flavoring oils and other hydrophobic ingredients. Because of this, dentifrice products containing triclosan may not have triclosan in a bioavailable state and, hence, the products themselves can not be assumed to possess antimicrobial activity. In order to determine the antimicrobial effects on dental plaque of a triclosan/pyrophosphate dentifrice relative to a negative control (without triclosan or pyrophosphate), a crossover 4-day non-brushing study was conducted. Thirty-four subjects were enrolled in this randomized two-period, double-blind crossover investigation with thirty-three subjects completing all aspects. Following a baseline plaque examination and complete plaque removal at the start of the first 4-day treatment period, subjects initiated a twice-daily supervised dosing regimen, during which they rinsed with their first assigned dentifrice in slurry form while refraining from tooth-brushing and all other oral hygiene procedures. Evaluations to quantify test product effects on plaque were conducted on Day 5. After a week-long interim washout period, subjects repeated the twice daily rinsing regimen over Days 1-4 of Treatment Period 2 with their second assigned product, again with examinations on Day 5. Analysis of data demonstrated subjects had significantly (p = 0.0296) less plaque when rinsing with the triclosan/pyrophosphate dentifrice slurry as compared to the negative control dentifrice slurry; the relative treatment difference as determined by the primary examiner was 12.7%. A trainee examiner observed a 16.0% reduction on a subset of subjects (p = 0.0139). This efficacy result compares favorably with results from other studies of triclosan-containing products. The examinations for oral safety demonstrated no meaningful clinical differences between the triclosan/pyrophosphate dentifrice and control dentifrice.

Assessing the efficacy of three dentifrices in the treatment of dentinal hypersensitivity.

A multicenter clinical trial conducted by the authors compared the desensitizing efficacy of a new 5 percent potassium nitrate: 0.243 percent sodium fluoride dentifrice along with two clinically proven, commercially available desensitizing dentifrices to a placebo dentifrice. Sensitivity to cold air and tactile stimulation, along with patients' subjective assessments, were evaluated to assess the dentinal desensitizing efficacy of the test dentifrices. Results demonstrated that after four weeks, participants who used the new dentifrice formulation experienced significant decreases in dentinal sensitivity compared to the placebo group for all measured indexes.

Crest Tartar Control benefits assessed by Quanticalc: clinical method and three-month results.

In this paper, a method is described for applying the Quanticalc (QC) dental scaler to the clinical assessment of tartar control dentifrice effects on supragingival calculus formation and therapist efforts required in subsequent calculus debridement. In a 3-month, randomized cross-over study, subjects using Crest Tartar Control were observed to form 25% less calculus than they formed in a similar period using Crest Regular non-tartar control dentifrice as placebo. QC measurements likewise revealed 25% savings in the developed force used to scale the anterior lingual surfaces, coupled with a 27% reduction in the number of strokes required to clean these surfaces free of supragingival calculus in subjects using tartar control dentifrice. The quantitative savings in professional effort amounted to 3 kg (developed forces saved) per subject using tartar control dentifrice. White subjects using placebo dentifrice for 3 months developed less calculus than shown at baseline (29% less calculus), this was not complemented by decreases in total force and strokes used in cleaning. This supports the hypothesis that the surface area coverage of calculus (e.g., the planimetric "area" of supragingival calculus on the tooth) does not contribute alone to the amount of effort as forces and strokes required in subsequent debridement. These results demonstrate that: 1) the QC dental scaler can be effectively used in the clinical assessment of scaling forces/efforts associated with supragingival calculus debridement; and 2) a tartar control dentifrice containing soluble pyrophosphate is clinically effective in reducing both the surface coverage of calculus and the therapist effort required in subsequent calculus debridement.

Quanticalc assessment of the clinical scaling benefits provided by pyrophosphate dentifrices with and without triclosan.

The Quanticalc (QC) dental scaler permits a quantitative assessment of the work used by professionals in calculus removal through the measurement of force dynamics and scaling strokes applied in calculus debridement. The purpose of this study was to use the QC to compare the clinical effects of two 5% pyrophosphate dentifrices on dental calculus in subjects following six-months' product use. Three-hundred forty-six subjects participated in a six-month, double-blind tartar control clinical trial involving traditional Volpe-Manhold Index (VMI) evaluations. Following the six-month VMI examinations, the subjects had a QC prophylaxis (scaling force measurements). The three dentifrice treatment groups included a control dentifrice (NaF only, Crest); NaF dentifrice containing 5.0% pyrophosphate (Crest Tartar Control); and NaF dentifrice containing 5.0% pyrophosphate plus 0.28% triclosan (antimicrobial). Subjects were balanced by baseline (pretest) VMI scores at the start of the trial. QC examinations revealed statistically significant reductions in total force and stroke number used by the therapist to scale the six anterior VMI teeth for subjects using the pyrophosphate tartar control dentifrices as compared to control dentifrice. The reduction in scaling effort amounted to almost 3 kg per scaling for subjects. QC results paralleled VMI reductions of calculus on the teeth and demonstrated that the use of 5% pyrophosphate dentifrices, with or without triclosan antimicrobial, results in significant reductions in the total (developed) force and strokes required by therapists in regular calculus debridement at a six-month interval. The clinical benefits of tartar control toothpastes may not only include reductions in cosmetically objectionable supragingival calculus, but in reducing professional effort in calculus debridement during regular prophylaxis.

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.

The clinical effect of dentifrices containing stabilized stannous fluoride on plaque formation and gingivitis--a six-month study with ad libitum brushing.

The effects of stabilized 0.454% stannous fluoride dentifrices on supragingival plaque, gingival inflammation and gingival bleeding were studied in 549 adult male and female subjects who completed a six-month, double blind clinical study. Following an oral prophylaxis, subjects were randomly assigned to brush with one of the following dentifrices: 1) 0.454% SnF2 stabilized with 2.08% sodium gluconate, 2) 0.454% SnF2 stabilized with 4.16% sodium gluconate, 3) an experimental dentifrice, or 4) 0.243% NaF control dentifrice. Follow-up examinations were conducted at 3 and 6 months. Compared to the control dentifrice at 6 months, stannous fluoride dentifrices stabilized with 2.08% or 4.16% sodium gluconate significantly reduced gingivitis by 18.8% and 18.0%, respectively. There were no statistically significant differences between the two stabilized SnF2 groups with respect to their beneficial effects on gingival health. Gingival bleeding was also reduced, relative to the control dentifrice, for both stabilized SnF2 dentifrices. However, these differences were not statistically significant at p=0.05. The stabilized SnF2 dentifrices were not significantly different from the control dentifrice in their effects on supragingival plaque. No significant differences in adverse oral soft tissue effects were observed between the test and control groups. As expected, accumulation of extrinsic tooth stain increased in the stabilized SnF2 groups. However, the difficulty in removing accumulated dental stain was similar between the control and stabilized SnF2 dentifrices. Since use of SnF2 dentifrices has been reported to produce tooth stain, gingivitis examinations were done with and without custom-made tooth covers to evaluate the potential for examiner bias. Comparable gingivitis and gingival bleeding benefits were observed when the evaluations were conducted with or without the tooth covers. Results from this study support that 0.454% stabilized stannous fluoride dentifrices can provide an important adjunct to the prevention and control of gingivitis when used in combination with regular personal oral hygiene procedures and professional care.

Microbiological assessment of an improved stannous fluoride dentifrice.

Recently, a new stabilized stannous fluoride (SnF2) dentifrice (SSF) has been developed. The aim of the present work was to examine the antimicrobial activity of SnF2, and to assess the long-term microbial safety of this dentifrice in a series of in vitro and clinical evaluations. Results of in vitro time-kill experiments with representative oral bacteria demonstrated that SnF2 exerts broad antimicrobial activity against both Gram-positives and Gram-negatives and, in particular, has potent activity against Streptococcus mutans. Sixty-eight subjects participated in a nine-day plaque regrowth clinical study to assess the short-term antiplaque effect of SSF. The results revealed no significant differences from the negative control, suggesting that SnF2 does not detectably or directly alter plaque microbial viability or composition. Separately, evaluation of microbial safety in a subgroup of 120 subjects participating in a six-month clinical efficacy and safety trial found no significant ecological shifts between SSF and the negative (NaF dentifrice) control among 11 supragingival microbial populations examined. The potential for development of bacterial resistance to SnF2 was assessed under both in vitro and clinical conditions. In a rigorous assessment of the ability of bacterial populations to develop either phenotypic or genotypic resistance to SnF2, representative bacteria were exposed to continuous sub-lethal concentrations of SnF2 in a laboratory chemostat for at least 9 days. Results of time-kill experiments on exposed populations revealed no significant changes in susceptibility despite exposure of over 10(12) bacteria. Based on typical spontaneous mutation rates of 10(-6) to 10(-8), these results suggested that the potential for bacteria to develop resistance to SnF2 is low. Evaluation of susceptibility to SnF2 to over 800 bacterial isolates obtained over the course of the six-month clinical trial corroborate the in vitro findings, revealing no changes in susceptibility suggestive of development of resistance to SnF2 is a microbiologically safe agent for oral use and support separate clinical observations demonstrating the safety and efficacy of this stabilized SnF2 dentifrice.

Reduction of calculus and Peridex stain with Tartar-Control Crest.

Regular use of an effective oral rinse (0.12% chlorhexidine [CHX]) may be accompanied by tooth staining and slightly increased calculus formation. Since dentifrices containing soluble pyrophosphates are known to significantly reduce calculus formation, this study was designed to investigate whether CHX-induced staining and increased calculus may be reduced by the use of such dentifrices. The study compared stain and calculus formation in 163 subjects using a CHX oral rinse (Peridex, Procter & Gamble) according to label directions and either a pyrophosphate-containing anticalculus toothpaste (Tartar-Control Crest, 3.3% pyrophosphate) or an otherwise similar toothpaste without pyrophosphate (Regular Crest). Subjects were instructed to brush and floss ad lib and were examined after three and six months. Whole-mouth calculus occurrence was significantly reduced in the anticalculus toothpaste group at three and six months. Also, staining on the cosmetically important facial-anterior surfaces was significantly reduced at the 3-month examination. After six months the difference in facial anterior staining was still directionally favorable to the anticalculus toothpaste group but no longer statistically significant. These results indicate that routine brushing with an anticalculus toothpaste such as Tartar-Control Crest significantly reduces both facial-anterior staining and calculus occurrence in subjects using a CHX oral rinse. Whether more frequent or more thorough brushing would lead to still greater reductions remains to be investigated.

Clinical effects of a 0.12% chlorhexidine rinse as an adjunct to scaling and root planing.

This trial tested the adjunctive effects of a 0.12% chlorhexidine rinse (Peridex) upon gingival healing following scaling and root planing. Assessments were made on reduction in plaque (Pl), gingivitis (GI), pocket depth and gingival bleeding as measures of treatment benefit. All subjects had Class II, III or IV periodontal conditions. Following baseline examinations, subjects received a gross supragingival scaling and polishing. Subjects were separated by sex and periodontal classification, arrayed by GI scores, and randomly assigned to either the chlorhexidine rinse or a placebo rinse. Subjects were instructed to rinse with 1/2 ounce of their assigned products for 30 seconds twice daily. Following two weeks of product use, the clinical examinations were repeated and two randomly selected, opposing contralateral quadrants were scaled and root planed. After two more weeks of product use (week 4), clinical examinations were repeated and the remaining quadrants were scaled and root planed. At week 6, final clinical examinations were conducted. Since half-mouths were treated at different times and exposed to the treatment rinses for different periods, the data were analyzed for the half-mouths independently 2 and 4 weeks after gross scaling, and 2 and 4 weeks after root planing. A total of 94 subjects (47 in each treatment group) completed all phases of the trial. Gingival healing following scaling and root planing in subjects using a chlorhexidine rinse (0.12%) was significantly better than subjects using the placebo rinse as evidenced by less gingivitis (29%), fewer GI bleeding sites (48%) and less plaque (54%).

A clinical comparison of antibacterial mouthrinses: effects of chlorhexidine, phenolics, and sanguinarine on dental plaque and gingivitis.

This study compared the clinical efficacy of three mouthrinses containing either 0.12% chlorhexidine, phenolic compounds, or sanguinarine, which were used unsupervised, in a placebo-controlled, double-blind study of 6 months' duration. The study was conducted according to ADA clinical guidelines for evaluation of antigingivitis agents and was completed by 481 adults. Following baseline exams and a prophylaxis, subjects were randomly divided into treatment groups matched for age, gender, and gingivitis severity, and were instructed to use the rinses in accordance with manufacturer's directions. Followup examinations evaluated supragingival plaque, gingivitis, and gingival bleeding. Compared to placebo at 6 months, the group rinsing with 0.12% chlorhexidine had significantly less gingivitis (31% reduction), gingival bleeding (39% reduction), and plaque (49% reduction) and was significantly better than any of the other treatment groups (P less than 0.05). Both the phenolic and sanguinarine groups showed moderate, yet significant, reductions in plaque compared to placebo (24% and 12% respectively) yet were significantly less effective than the 0.12% chlorhexidine rinse (P less than 0.05). However, neither the phenolic nor sanguinarine rinses were significantly different than placebo in their effects on gingivitis or gingival bleeding. These results support previous published results on the superiority of 0.12% chlorhexidine when used in conjunction with professional care and as an adjunct to routine oral hygiene practices.

A comparison of 3 clinical indices for measuring gingivitis.

A clinical study was conducted among 200 adult males and females to compare the intrusive gingival index (GI) for estimating gingivitis with the nonintrusive and only visually applied papillary-marginal-gingivitis index (PMGI). The GI examinations were performed by a senior examiner with long experience and a junior examiner, while the PMGI was graded by only a senior examiner with long experience. A 4th examiner was included for grading bleeding sites by gentle intrusion at the orifice of the gingival crevice. Following the baseline examination by all examiners, the subjects were randomly assigned to either a group that received an oral prophylaxis immediately or to a group that received an oral prophylaxis 6 weeks after the baseline. All subjects were regraded by all examiners 4 days after the 2nd group received a prophylaxis. This delayed prophylaxis design created a difference in the responses between treatment groups. Both the GI examiners and the PMGI examiner concluded there was significantly less gingivitis in the group receiving a prophylaxis second. There were also significantly fewer bleeding sites in the group receiving a prophylaxis second as determined by both GI examiners and the bleeding-sites examiner.

Statistical transformations of indices of gingivitis measured non-invasively.

An index (PMGI) that combines the Massler-Schour (PMA) and Löe-Silness (GI) indices for non-invasive scoring of gingivitis was applied in 2 independent comparative clinical studies. 4 statistical transformations of the scores of individual papillary and marginal units were analyzed: the whole-mouth mean, its square root, the proportion of units judged to be inflamed, and its arc sin transformation. According to the criteria of how closely the transformations produced approximately normal distributions, and of how successful they were in detecting treatment differences, the square root transformation performed the best.

A clinical procedure for determining the proficiency of gingivitis examiners.

The purpose of the present study was to evaluate a clinical procedure for determining the proficiency of gingivitis examiners. After 4 examiner trainees were instructed by and participated in practice examination sessions with a senior examiner, the 5 examiners participated in a 2-group clinical study which employed appropriately timed-staggered dental prophylaxes to create a gingivitis treatment effect between the 2 groups. The 1st group received dental prophylaxes 30 days before the 2nd group. 10 days after the 2nd group had received dental prophylaxes, both groups were examined independently by all 5 examiners. Baseline examinations had been made on all subjects by all 5 examiners independently to serve as a covariable in the statistical analyses. During this clinical exercise, the examiners did not know at what time prophylaxes had been given nor did they have access to the previous examination records. The expected presence of a treatment effect, as confirmed by the senior examiner, was found by all of the examiner trainees in this exercise. The treatment effect for all examiners was statistically significant.