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A clinical evaluation of a sodium fluoride dentifrice.

A double-blind study to determine the anticaries efficacy of a neutral pH dentifrice containing sodium fluoride and a high Beta-phase calcium pyrophosphate was conducted among elementary school children in Kansas City, Missouri. A sample of 567 children ages 8-13 were recruited and randomly assigned to test and control groups: the test group received a sodium fluoride high Beta-phase calcium pyrophosphate dentifrice, and the control group received a calcium pyrophosphate dentifrice without the active ingredient. The sodium fluoride dentifrice contained fluoride at the level of 1000 ppm. Caried examinations were conducted at initiation, after 12 months, and again after 24 months at the study's termination. All examinations (clinical and radiographic) were performed by the same investigator. At 12 months the sodium fluoride dentifrice demonstrated a caries reduction of 24.1% (DMFS). At 24 months the reduction demonstrated was 30.1% (DMFS); this reduction is significant at alpha = 0.05.

Adolescent↗

Clinical effect of a triclosan containing dentifrice on gingivitis during pregnancy and post-partum.

One hundred forty pregnant women 3 months gestation were enrolled in a 9 month, double-blind clinical study to evaluate the effect of 0.3% triclosan/copolymer dentifrice on gingivitis, compared to a placebo dentifrice. Women were stratified into two balanced groups according to their baseline gingivitis scores. They then received oral prophylaxis and were assigned to use either a placebo or the triclosan dentifrice for the next 9 months. The 3, 5 and 9 month results of this study showed that the triclosan dentifrice provided statistically significant reductions in gingivitis of 19.73, 27.91and 38.45%, respectively, compared to the placebo dentifrice.

Adult↗

A clinical trial on the effectiveness of professional toothbrushing using dentifrice and water.

The purpose of this trial was to compare the plaque removal effectiveness of professional toothbrushing with dentifrice and with only water. Fifty three subjects were divided into a dentifrice and a water group. Both groups had their teeth professionally brushed for one minute using either dentifrice or water. Plaque scores were recorded before and immediately after brushing. The results of this trial show that toothbrushing with dentifrice was more effective in removing plaque compared to brushing with water alone. The amount of plaque reduction was low, and varied with tooth surfaces. The mid buccal surface had the greatest reduction of plaque. No significant differences were observed on the distobuccal and distolingual surfaces when the dentifrice group was compared with the water group.

Dental Plaque↗

Effect of a triclosan/copolymer/fluoride dentifrice prophylaxis on the shear bond strength of a composite resin to enamel.

A new fluoride dentifrice formulation containing triclosan and a copolymer has been introduced. The purpose of this study was to evaluate the shear bond strength of a resin composite bonded to enamel previously cleaned with this new dentifrice formulation. A total of 45 human extracted permanent molars were used. A flat enamel surface was obtained with 600 grit SiC paper and the teeth randomly distributed into 3 groups of 15 teeth each: Group 1: Pumice prophylaxis with a rubber cup and slow-speed handpiece; Group 2: Prophylaxis with a conventional fluoridated dentifrice (Colgate); Group 3: Prophylaxis with a triclosan/copolymer/NaF dentifrice (Colgate). After prophylaxis, the teeth were acid-etched with a 37% phosphoric acid gel for 30 seconds, rinsed and dried. An unfilled resin (Coe Bond) was thinly applied with a brush and cured for 30 seconds. A nylon ring was placed over the area and filled with a light-cured resin composite (Occlusin). The teeth were thermocycled for 100 cycles, mounted in plastic cups and plaster, and sheared with a knife-edged blade in an Instron running at a crosshead speed of 1 mm/min. The results in MPa were as follows: Group 1: 11.34 +/- 4.57; Group 2: 13.46 +/- 3.60; Group 3: 13.84 +/- 4.33. An ANOVA showed that there was no statistically significant difference among the groups. Fracture within the enamel occurred in 27% in Group 1, 47% in Group 2, and 67% in Group 3. The results support the use of the fluoride dentifrices tested in this study for prophylaxis prior to bonding procedures.

Analysis of Variance↗

Anti-plaque dentifrices: current status and prospects.

A dentifrice can, in principle, be an effective delivery vehicle for anti-plaque agents, provided bioavailability of the agent concerned can be achieved, because the agent is applied and delivered at the site of action and favourable patient compliance can be obtained. It is widely assumed that anti-plaque agents need to be retained in the oral cavity after application ('substantivity'). To use a dentifrice as a dosing vehicle successfully the anti-plaque agents have to be compatible with the dentifrice formulation to achieve release from the formulation and subsequent retention of the anti-plaque agent after application. Various anti-plaque agents have been described, such as quarternary ammonium compounds (e.g., chlorhexidine), metal ions and phenolic agents. Recently progress has been achieved with a selection of compatible anti-plaque agents for inclusion in a dentifrice such as metal ions and non-charged phenolic agents. Studies on long-term unsupervised brushing have shown favourable anti-plaque and anti-gingivitis activity from anti-plaque agents dosed from a dentifrice [corrected].

Dental Plaque↗

Bicarbonate-based powder and paste dentifrice effects on caries.

The effects of sodium bicarbonate-based powder and paste dentifrices on dental caries and Streptococcus sobrinus recoveries in rats were studied. Three S. sobrinus 6715-13WT infected groups of specific pathogen-free weanling rats, consuming a diet which contains 56% sucrose, were topically treated with either demineralized water, dentifrice paste, or dentifrice powder. Both the paste and powder contained 0.22% (w/w) NaF. All topical treatments were given for one min daily per rat, five days a week. Animals' teeth were swabbed for recovery of 6715-13WT and total recoverable flora. Recoveries of 6715-13WT were 75% lower from both powder-treated and paste-treated dentifrice than from water-treated rats' teeth (p less than 0.001). Total caries scores were 45% lower for the powder-treated and 43% lower for the paste-treated rats than the water-treated ones (p less than 0.01). The major portion of the caries inhibition was evident on smooth tooth surfaces, 68% for powder-treated and 65% for paste-treated by comparison with water-treated animals (p less than 0.01), although a lesser caries reduction was also evident in tooth fissures (sulci). Thus, both powder and paste formulations of a sodium bicarbonate-based dentifrice containing 0.22% NaF equally and potently inhibited caries in rats, challenged bacteriologically and dietarily to develop severe caries.

Animals↗

The effectiveness of two test dentifrices on dental plaque formation: a 1-week clinical study.

A 1-week, double-blind clinical study was conducted to compare the effects on plaque formation of two test dentifrices with a placebo dentifrice. Male and female adult subjects received an oral prophylaxis and were randomly allocated to three study groups. The subjects used the dentifrice three times daily and were examined for the presence of plaque after seven days. The results indicated that one of the two test dentifrices, containing 0.3% triclosan, 2% of a copolymer, and 0.76% sodium monofluorophosphate in an insoluble sodium metaphosphate abrasive system, significantly reduced plaque formation by 16% when compared to the placebo dentifrice.

Adult↗

A clinical evaluation of the relative cariostatic effect of dentifrices containing sodium fluoride or sodium monofluorophosphate.

A three-year clinical trial was conducted to determine whether a sodium fluoride (NaF) dentifrice had greater cariostatic effects than a sodium monofluorophosphate (Na2PO3F) dentifrice. Both dentifrices contained 1100 ppm fluoride and silica abrasive systems. A panel of 3,290 children, age 6-16, received one of the two dentifrices for ad libitum home use. The subjects were examined for caries at the baseline and after 2 and 3 years. Results were analyzed both for all children and for those children age 11 years or older at the baseline. The older children were found to have about 50 percent higher new caries increments than did the entire panel of children. In the older, caries- prone children, the subjects using the NaF product experienced significantly (15 percent and 12 percent) fewer new lesions than did the subjects using the Na2PO3F product after 2 and 3 years respectively. In the panel of all children, subjects using the NaF product had numerically, but not significantly, fewer new lesions. The results for this study, showing significantly greater cariostatic benefits in caries-prone children for a sodium fluoride dentifrice with a highly compatible system, are consistent with findings of other investigators.

Adolescent↗

Dentin abrasion (RDA), enamel abrasion (REA) and polishing scores of dentifrices sold in Switzerland.

Assessments of the abrasion of hard dental tissues produced by different dentifrices are usually carried out on extracted teeth in the laboratory. The tests most commonly used to measure dentifrice abrasion on dentin and enamel are the radiotracer (radio-active) and profilometry methods. The radiotracer dentin (RDA) and enamel (REA) abrasion scores of the 32 dentifrices were determined using the ADA specifications. RDA and REA scores are related to a standard abrasive, calcium pyrophosphate (Ca2P2O7), which is assigned a score of 100 for the RDA method and 10 for the REA method. The same abrasive was used as the standard in the enamel polish study and assigned a score of 100. The RDA scores of the dentifrices tested varied from 37 to 203, the REA scores from 1.0 to 11.7, and the polishing scores ranged from 19.63 to 96.88. Half the dentifrices tested had RDA scores below 100.

Dental Enamel↗

On dental health in Icelandic children. Observations during a clinical dentifrice trial.

Dental health and the relative caries preventive effect of different fluoride dentifrice formulations were assessed in an Icelandic child population. For a cross sectional study 1370 children, aged 11 and 12 years were examined for caries and periodontal conditions employing standardized methods. Longitudinal data were obtained from 1161 children, participating in a three-year dentifrice trial. Randomly selected subgroups were employed to study salivary levels of mutans streptococci and lactobacilli, consumption of high-sucrose products and enamel fluoride content in relation to caries experience. Relative caries preventive effect of anticalculus agents (HEBP and AHBP) and lowered fluoride concentration (250 ppm) in dentifrices were evaluated in a three-year double blind randomized clinical trial. At the baseline examination a comparatively high mean caries prevalence (DFS 9.9) was registered. Longitudinal observations showed a mean caries increment of 10.5 surfaces during a three-year period. Simultaneously an improvement of gingival health was observed. A majority of children harbored mutans streptococci (98%) and lactobacilli (92%). High numbers of either microorganism were associated with high caries prevalence. S. sobrinus carriers were more frequent among children with high numbers of CFU per ml saliva. The consumption of sugar-containing products was generally frequent. Higher caries increment was associated with consumption of sweets and bakery products during mealtimes. The fluoride content of surface enamel was comparatively low, reflecting scarce post eruptive exposure. Dentifrice, containing 250 ppm fluoride showed significantly lower caries preventive effect compared to 1000 ppm sodium fluoride and MFP formulations. Addition of anticalculus agents (biphosphonates) had no negative effect on reducing caries increment. These studies show that dental caries constitutes a major health problem among Icelandic children, where high sugar consumption and comparatively low exposure to fluoride appear to play major roles. The use of fluoride dentifrice has not been able to limit caries development.

Child↗

[Analysis of the use of fluoridated dentifrices in Curitiba].

The use of fluoride dentifrices in Curitiba (Brazil) was studied. The scholarity and socio-economical levels of the population were related to the use of fluoride dentifrices. The sample was composed of 155 persons, men and women. The results showed that 96.8% used dentifrices, but only 36.2% used fluoride dentifrices. The use of fluoride dentifrices was more significant among the higher socioeconomical and school levels.

Brazil↗

The effects of a silica dentifrice containing Triclosan and zinc citrate on supragingival plaque and calculus formation and the control of gingivitis.

A double blind, 7-month parallel clinical study was conducted to determine the effect of a dentifrice containing 0.3 per cent Triclosan and 0.75 per cent zinc citrate in a 0.8 per cent sodium monofluorophosphate/silica base on supragingival plaque, gingivitis and supragingival calculus formation, compared to a 0.8 per cent monofluorophosphate/silica control dentifrice. The results of this clinical study demonstrate that the use of the Triclosan/zinc citrate dentifrice over a 7-month period provided a statistically significant and clinically relevant benefit in controlling gingivitis, compared to a control dentifrice. Supragingival plaque and calculus levels were also significantly reduced in comparison to the effects of a control dentifrice.

Adult↗

Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice.

OBJECTIVE: Stannous fluoride is a broad-spectrum anti-microbial agent that has been used in dentistry as a chemical adjunct to prevent dental caries and gingivitis. The objective of this study was to assess the anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice relative to a negative control. METHODS: This was a randomized, 6-month, double-blind, parallel-group gingivitis study conducted according to the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 s using their assigned product. Oral soft-hard-tissue examinations and clinical examinations using the Modified Gingival Index, Gingival Bleeding Index, and the Turesky modification of the Quigley-Hein Plaque Index were performed at baseline, 3 and 6 months post-treatment. RESULTS: A total of 143 subjects were enrolled and 130 of them completed the 6-month study. After 6 months of product usage, the experimental group had 21.7% less gingivitis (p<0.001), 57.1% less bleeding (p<0.001), and 6.9% less plaque (p=0.01) on average compared with the negative control group. No adverse oral soft-hard-tissue effects or extrinsic tooth staining was observed in the study. CONCLUSION: The results demonstrate that use of the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice over a 6-month period provided statistically significant reductions in gingivitis, gingival bleeding, and plaque when compared with a negative control dentifrice.

Adolescent↗

One-year study of the efficacy of a dentifrice containing zinc citrate and triclosan to maintain gingival health.

In a previous study we demonstrated that gingival health could be maintained in a group of highly motivated nurses using a dentifrice containing a zinc salt and triclosan. We have now investigated the effect of the experimental dentifrice on a group of less motivated men. One hundred and three male students were given oral hygiene instruction (OHI) and their teeth were professionally cleaned. For each individual, both the instruction and cleaning were completed in a single 15-min period. Two balanced groups were formed, based on the prestudy plaque levels and gingival bleeding. One group used the experimental dentifrice for 12 months, while the other used a control. Results were assessed after 6 months, and after 12 months. As a result of the OHI, plaque and gingival bleeding were reduced at the end of the prestudy period. This improvement was not maintained by the control group even for 6 months. In contrast, the test group exhibited significantly lower plaque levels and higher standard of gingival health throughout the 12 months. Reassessment of available participants 6 months after the study showed that gingival health in both groups had returned to its prestudy condition. The lower observed standard of gingival health in the test group after ceasing to use the experimental dentifrice further supports the conclusion that this dentifrice can contribute to an oral care program.

Adult↗

Laboratory enamel solubility reduction and fluoride uptake from enamelon dentifrice.

The presence of calcium-releasing ingredients in toothpastes containing sodium fluoride is usually avoided to prevent loss of active fluoride due to the formation of the insoluble calcium salt. The purpose of this study was to determine the bio-availability of fluoride from Enamelon Toothpaste (E), which simultaneously supplies fluoride, calcium and phosphate salts from a dual dispensing package. Fluoride uptake into artificially lesioned enamel cores due to the use of the test dentifrice (E) diluted 1:3 in whole human saliva was compared to that from a clinically proven effective sodium fluoride/silica USP reference toothpaste (C) and a non-fluoride control (E-w/o F). Enamel solubility reduction due to the use of E, C and E-w/o F was measured by determining the quantity of phosphate released to lactic acid buffer before and after treatment of the crowns of molars with 1:3 slurries of the dentifrices in water. Fluoride uptakes and enamel solubility reductions were 5031 +/- 158 ppm and 21.6 +/- 2.2% for E, 1915 +/- 39 ppm and 13.6 +/- 2.0% for C, and -3 +/- 2 ppm and 0.8 +/- 1.7% for E-w/o F. The fluoride uptake and enamel solubility reductions from E were significantly greater than from C (p < 0.001, Fisher LSD), and both fluoride-containing dentifrices significantly outperformed E-w/o F (p < 0.001). The laboratory results indicate that the calcium and phosphate salts delivered by the remineralizing Enamelon dentifrice increase the bioavailability of fluoride to substantially exceed that of the clinically proven standard dentifrice.

Analysis of Variance↗

Advanced oral antibacterial/anti-inflammatory technology: A comprehensive review of the clinical benefits of a triclosan/copolymer/fluoride dentifrice.

INTRODUCTION: Triclosan is a broad-spectrum antibacterial agent, marketed for use in oral products. It is effective against both gram-positive and gram-negative bacteria. PVM/MA is the non-proprietary designation for a polyvinylmethyl ether maleic acid copolymer. It has been demonstrated that there is a greater uptake of triclosan to enamel and buccal epithelial cells from the use of a fluoride dentifrice containing triclosan and the PVM/MA copolymer than from a dentifrice containing triclosan alone. This Supplement details the results of antibacterial, anti-inflammatory, and short- and long-term plaque and gingivitis studies with a triclosan/copolymer/ fluoride dentifrice. Additionally, the Supplement reviews studies on the effect of a triclosan/copolymer/fluoride dentifrice on periodontitis, calculus, caries, whitening and stain removal, oral malodor, and on the microflora. CONCLUSION: Clinical studies indicate that the use of a triclosan/copolymer/fluoride dentifrice (Colgate Total Toothpaste) may provide oral health benefits beyond those associated with "traditional" toothpaste use, in a manner that is safe and effective. Studies presented in this Supplement demonstrate that Colgate Total Toothpaste provides superior protection against plaque and gingivitis, caries, oral malodor, exhibits superior stain removal, and provides protection against the progression of periodontal disease.

Anti-Infective Agents, Local↗

Cariostatic effects of monofluorophosphate in solutions and dentifrices in rats.

The cariostatic effectiveness of dentifrices and solutions containing sodium monofluorophosphate (MFP) was evaluated in rats. In one study using 36 CARA rats, the caries inhibiting effects of sodium fluoride and MFP solutions, at equivalent soluble fluoride concentrations (750 ppm F), were compared. Both MFP and sodium fluoride significantly (p less than 0.01) reduced smooth surface caries by 78% to 81%, respectively. No significant differences between the two treatment groups were observed. In a second study, 5 dentifrices formulated with dicalcium phosphate dihydrate (DCPD) abrasive and different amounts of MFP (0, 250, 500, 750, and 1000 ppm F) were tested for cariostatic effects in CARA rats. Compared to the control groups, the MFP/DCPD dentifrices significantly (p less than 0.01) reduced smooth surface caries incidence by 66%, 81%, 76% and 85% at the 250, 500, 750, and 1000 ppm F concentrations, respectively. In each of the studies, both enamel fluoride content and molar surface solubility were measured. A third study assessed the compatibility of MFP with different abrasives and the effect of dentifrice composition on the release of MFP from a dentifrice slurry to a saliva phase. No differences in MFP release were observed for two different silica-based formulations which differed with respect to thickener, humectants and other ingredients.

Animals↗

Antimicrobial effects of a new therapeutic liquid dentifrice formulation on oral bacteria including odorigenic species.

The control of oral malodor is well-recognized in efforts to improve oral health. Antimicrobial formulations can mitigate oral malodor, however, procedures to assess effects on oral bacteria including those implicated in halitosis are unavailable. This investigation examined the antimicrobial effects of a new liquid triclosan/copolymer dentifrice (test) formulation that demonstrated significant inhibition of oral malodor in previous organoleptic clinical studies. Procedures compared antimicrobial effects of the test and control formulations on a range of oral micro-organisms including members implicated in halitosis, substantive antimicrobial effects of formulations with hydroxyapatite as a surrogate for human teeth and ex vivo effects on oral bacteria from human volunteers. With Actinomyces viscosus, as a model system, the test formulation demonstrated a dose-dependent effect. At these concentrations the test formulation provided significant antimicrobial effects on 13 strains of oral bacteria including those implicated in bad breath at selected posttreatment time points. Treatment of hydroxyapatite by the test dentifrice resulted in a significant and substantive antimicrobial effect vs. controls. Oral bacteria from subjects treated ex vivo with the test dentifrice resulted in significant reductions in cultivable oral bacteria and odorigenic bacteria producing hydrogen sulfide. In summary, microbiological methods adapted to study odorigenic bacteria demonstrate the significant antimicrobial effects of the test (triclosan/copolymer) dentifrice with laboratory and clinical strains of oral bacteria implicated in bad breath.

Actinomyces viscosus↗