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The comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the control of gingivitis: a 6-month randomized clinical study.

BACKGROUND: Antimicrobial agents such as stannous fluoride and triclosan have been incorporated into dentifrice formulations and have been shown to be effective in reducing gingivitis. The objective of this study was to compare the anti-gingivitis efficacy of a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice to a positive control triclosan/copolymer dentifrice. METHODS: This was a 6-month, randomized, double-masked, parallel-group study conducted according to the American Dental Association guidelines for evaluating chemotherapeutic products for the control of gingivitis. A 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available positive control dentifrice (0.30% triclosan/2.0% Gantrez copolymer). Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 seconds using their assigned product. Tooth brushing was supervised for 3 days of each week. Clinical examinations using a gingival index were performed at baseline and at 3 and 6 months. RESULTS: A total of 199 subjects were enrolled and 186 completed the 6-month study. Average baseline gingivitis and bleeding scores were similar for the two treatment groups. After 6 months, the experimental group had statistically significantly less gingivitis (25.8%) and statistically significantly less bleeding (27.4%) on average compared to the control group. Neither adverse oral soft tissue effects nor tooth staining were reported. CONCLUSION: Within the limits of the study protocol, the results demonstrated superior therapeutic benefits for the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice in reducing gingivitis compared to the triclosan/copolymer control in this partially supervised study.

Adolescent↗

An investigation of the transverse technique of dentifrice application to reduce the amount of fluoride dentifrice for young children.

PURPOSE: Recent studies have shown an increase in the prevalence of fluorosis. Consequently, recommendations for the use of a small quantity of fluoride dentifrice, 0.25 to 0.5 g or the equivalent of a "pea size" amount for children, have been made. This study evaluated a method of placing dentifrice in a transverse relation to the bristles (TT) and compares it to the standard technique used (ST) and to the "pea size" recommendation (PS). METHODS: The study was conducted in three phases: the first was in a laboratory setting using 22 commercial brands of children's toothbrushes; the second evaluated various recommendations with 240 mothers (Brazilian and Peruvian); and the third evaluated these recommendations in 135 Peruvian children (ages 4 to 6). RESULTS: The results showed that the mean quantity of dentifrice used with ST, PS, and TT was 0.58 g, 0.34 g, and 0.27 g for the mothers and 0.46 g, 0.29 g, and 0.24 g for the children, respectively. The average TT obtained through multiple weighing of 22 children's toothbrushes was 0.22 g. Both recommendations (PS and TT) reduced the amount of dentifrice used. However, TT also yielded a smaller variation range. Mothers and children learn easily and prefer TT. CONCLUSION: This technique could be recommended for young children in order to decrease the amount of fluoride dentifrice used, hence minimizing the potential inadvertent ingestion of fluoride dentifrice.

Brazil↗

Comparison of 2 desensitizing dentifrices with a commercially available fluoride dentifrice in alleviating cervical dentine sensitivity.

Previous studies have demonstrated efficacy of desensitizing dentifrices containing strontium acetate/sodium fluoride (SrAc2F) and potassium chloride/sodium monofluorophosphate (KCl/MFP) in alleviating discomfort arising from cervical dentine sensitivity (CDS). The aim of this investigation, therefore, was to determine efficacy of a SrAc2F dentifrice compared with KCl/MFP and a commercially available fluoride dentifrice containing sodium fluoride/sodium monofluorophosphate (NaMFP). Fifty-six patients participated in a 2-center double-blind, 3-way comparative parallel 6-week clinical study. Patients were evaluated at 0, 2, and 6 weeks for tactile (Yeaple probe), air sensitivity (dental air syringe), and subjective perception of pain (VAS scores). Results for Yeaple probe scores (Wilcoxon tests) between 2 weeks and baseline were highly significant for KCl/MFP, significant for NaMFP and nonsignificant for SrAc2F; scores between 6 weeks and baseline were, however, highly significant for all groups. Subjective Yeaple probe VAS scores (paired t-tests) between 6 weeks and baseline were significant for all groups; significance was demonstrated in the KCl/MFP group between 2 weeks and baseline. Subjective air visual analogue scores (paired t-tests) between 2 weeks and baseline were highly significant for all groups. There were no significant differences between groups at any time point. The results of the study demonstrated that the commercially available fluoride-containing dentifrice was as effective as the 2 desensitizing dentifrices in alleviating CDS over time.

Acetates↗

The comparative anticaries efficacy of a dentifrice containing 0.3% triclosan and 2.0% copolymer in a 0.243% sodium fluoride/silica base and a dentifrice containing 0.243% sodium fluoride/silica base: a two-year coronal caries clinical trial on adults in Israel.

The purpose of this two-year clinical study was to provide a comparison of the anticaries efficacy associated with two commercially available, American Dental Association-accepted dentifrices: Colgate Total Toothpaste, which contains 0.3% triclosan and 2% copolymer in a 0.243% sodium fluoride/silica base; and Crest Cavity Fighting Toothpaste with Fluoristat, which contains 0.243% sodium fluoride in a silica base. The study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. The study employed a double-blind parallel-group design, and involved adults living in communities throughout Israel. Qualifying subjects were randomly assigned to the two treatment groups, with multiple subjects in the same household all assigned to the dentifrice randomly allocated to the first among them. Caries examinations were conducted in accordance with U.S. Food and Drug Administration guidelines for the clinical evaluation of drugs to prevent dental caries. Two calibrated examiners performed all of the measurements. After treatment assignment, study participants were instructed to brush their teeth at home with their assigned dentifrice at least twice daily. Brushing instructions were reinforced by indoctrination in proper oral hygiene techniques by dental professionals, supplemented by pamphlets supplied by the sponsor and yearly mailings to participants, emphasizing good oral hygiene and the need to ensure compliance with the study. Post-baseline examinations were performed after one year of product use, and again after two years of product use. Three-thousand, three-hundred and ninety-two (3,392) subjects completed this two-year study. For these subjects, the mean caries scores (DFS, decayed or filled surfaces) at baseline were 21.96 for the Colgate Total Toothpaste group, and 21.49 for the Crest Cavity Fighting Toothpaste with Fluoristat group. For caries increment after one year, the respective means were 1.37 for the Colgate Total Toothpaste group, and 1.56 for the Crest Cavity Fighting Toothpaste with Fluoristat group. After two years, the mean caries increments were 1.46 for the Colgate Total Toothpaste group, and 1.75 for the Crest Cavity Fighting Toothpaste with Fluoristat group. No statically significant difference was indicated between the treatment groups at baseline. However, for both the one-year and two-year increments, there was a statistically significant difference between treatment groups. Relative to the Crest Cavity Fighting Toothpaste with Fluoristat group, the Colgate Total Toothpaste group presented a 12.2% reduction in caries increment scores at one year, and a 16.6% reduction in caries increment scores at two years. In accordance with the procedures and standards provided by the published guidelines of the American Dental Association for the comparison of the anticaries efficacy of fluoride dentifrices, the results of this study support the conclusion that Colgate Total Toothpaste provides a superior level of coronal anticaries efficacy compared to Crest Cavity Fighting Toothpaste with Fluoristat.

Adult↗

Antiplaque effects of dentifrices containing triclosan/copolymer/NaF system versus triclosan dentifrices without the copolymer.

A dentifrice containing triclosan/PVM/MA, Colgate Gum Protection Formula Toothpaste (GPF), was found to be highly effective against oral bacteria with minimal inhibitory concentration ranging from 0.3 to 5.35 micrograms/ml. A variety of in vitro model systems simulating oral environment were used to compare dentifrices containing triclosan/PVM/MA versus the dentifrices containing triclosan without PVM/MA, such as Crest Gum Health Toothpaste (CGH) and Neo-Mentadent P Toothpaste (N-MP). The uptake of triclosan on saliva-coated hydroxyapatite (HA) disks and buccal epithelial cells was significantly higher from the GPF versus the other dentifrices. Uptake on HA disks was 132 micrograms/disk versus 11 micrograms/disk from CGH; on buccal epithelial cells the uptake was 59 micrograms/2 x 10(5) cells with GPF versus 30.0 micrograms with CGH per same number of cells. The retained triclosan on the surfaces provided a sustained and higher antibacterial effect up to 4 hours post-treatment with GPF, but not with N-MP and CGH. In dynamic plaque model systems such as the chemostat or the controlled saliva flow system, GPF was significantly (P = 0.05) more effective than N-MP or CGH in reducing plaque thickness, protein and carbohydrate contents of plaque films. Collectively, the results of these microbiological and biochemical investigations indicate that the GPF has the potential to provide superior clinical efficacy versus the dentifrices without the copolymer.

Dental Plaque↗

Enamel caries formation and lesion progression with a fluoride dentifrice and a calcium-phosphate containing fluoride dentifrice: a polarized light microscopic study.

The effects of a fluoride dentifrice (Colgate Total) and a calcium-phosphate containing fluoride dentifrice (Enamelon) on caries-like enamel lesion formation and progression were evaluated in vitro. One quarter from each tooth (n = 12) was assigned to one of the study groups: 1) control group [artificial saliva only]; 2) Colgate Total; and 3) Enamelon. The dentifrices were applied to the enamel windows (3 minutes, 3 time per day for 14 days). Following treatment, enamel lesions were created with an acidified gel. After lesion initiation, sections were obtained for polarized light microscopy. To evaluate lesion progression, enamel windows with caries-like lesions in each test group were treated again for 14 days, returned to acidified gels for lesion progression, and then sections were obtained for polarized light microscopy. Mean lesion depths (polarized light, water imbibition) were as follows: 1) Lesion Initiation: Control 109 +/- 19 microns, Colgate Total 76 +/- 14 microns, Enamelon 63 +/- 17 microns; 2) First Lesion Progression: Control 164; +/- 24 microns, Colgate Total 124 +/- 22 microns, Enamelon 110 +/- 19 microns; 3) Second Lesion Progression: Control 235 +/- 23 microns; Colgate Total 172 +/- 27 microns, Enamelon 153 +/- 18 microns. Both Colgate Total and Enamelon enhanced the resistance of sound enamel and caries-like enamel lesions to a continuous in vitro cariogenic challenge when compared with matched controls (P < .05, ANOVA, DMR). Enamelon provided a further reduction in lesion depth for all periods when compared with Colgate Total (P > .05, ANOVA, DMR). Addition of bioavailable calcium and phosphate ions to a fluoride dentifrice may improve the ability of enamel to resist caries initiation and subsequent lesion progression.

Analysis of Variance↗

Six-month evaluation of Parodontax dentifrice compared to a placebo dentifrice.

Parodontax dentifrice, containing herbal ingredients and a sodium bicarbonate abrasive, has shown antiplaque effectiveness in laboratory and short term clinical studies. This study was to evaluate the efficacy of Parodontax versus a calcium carbonate placebo dentifrice using American Dental Association guidelines. Subjects (128) were randomly assigned to the two groups. Indices used were plaque area, gingivitis, bleeding on probing and stain at baseline, three and six months of unsupervised home use. With a minimal acceptable level of significance set at p < .05, the results of the ANOVA found no differences between the two groups on any parameter monitored at baseline or on the stain scores between the groups at any point in the study. Plaque area scores decreased with time in both groups and at three and six months Parodontax was significantly lower compared to the placebo on total surfaces. At six months, gingivitis scores decreased significantly in both groups compared to baseline. Bleeding on probing scores at six months were significantly lower in the Parodontax group compared to the placebo group. In this clinical study Parodontax dentifrice was found to be an effective agent for reducing plaque area, bleeding on probing and gingivitis.

Adolescent↗

A three-year clinical comparison of a sodium monofluorophosphate dentifrice with sodium fluoride dentifrices on dental caries in children.

This study compared the anticaries effects of these three fluoride-containing dentifrices: 1100 ppm F as NaF (positive control); 2800 ppm F as SMFP; and 2800 ppm F as NaF. The group using the 2800 SMFP dentifrice showed no significant differences in DMFS or DMFT, compared to the positive control, at anytime during the study. This indicated that higher levels of sodium monofluorophosphate in a dentifrice offer no advantage in caries protection over the conventional level of sodium fluoride, 1100 ppm F.

Adolescent↗

Remineralization of human enamel in situ after 3 months: the effect of not brushing versus the effect of an F dentifrice and an F-free dentifrice.

The in situ remineralization of 100-microns-deep enamel lesions positioned in a full prosthesis just under the first molar was determined in 13 participants after 3 months. The outer surface of the samples was always flush with the acrylic surface: there was no measurable plaque accumulation on the samples. The effect of not brushing of the samples (A) is compared with the effect of brushing with a nonfluoridated dentifrice (B) or with a fluoridated paste (C) containing 1,250 ppm F. The results show that lesion depth (and mineral loss) data increase by about 50% (case A), do not change statistically in case B and decrease by about 40% in case C. The increase of lesion depth in case A is most likely due to acidic food and/or beverage intake by the participants. With respect to nonbrushing, the remineralization effect of brushing with an F-free paste is about 50% and with the fluoridated paste about 90% in 3 months. It is suggested that the remineralization efficacy of fluoridated pastes is due to the cleaning effect of the brushing by the dentifrice (presumably on the pellicle) as well as due to the fluoride effect on mineral nucleation and growth.

Adult↗