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New laboratory methods to study tooth surface coverage and interproximal plaque control by dentifrice products.

OBJECTIVE: To develop and test an in vitro tooth model for use in conjunction with laboratory methods to study interproximal effects and efficacy of dentifrices. The application of the model should offer visual evaluation of dentifrice coverage of the tooth surface, and measure dental plaque control at posterior interdental spaces with a dentifrice. METHODOLOGY: The dentifrice products tested with the model were: Colgate Total 2 in 1 Toothpaste and Mouthwash (CTTM), Colgate Total dentifrice (CTD), and Colgate Regular dentifrice (CRD). Extracted human posterior teeth were disinfected, cleaned, aligned, and mounted in denture acrylic. In the area coverage method, tooth surface coverage and penetration of two different forms of dentifrice products (CTTM and CRD) were compared using digital photography. In the interproximal plaque control method, the teeth were coated with human saliva and incubated anaerobically with a mixture of representative oral bacteria for six hours at 37 degrees C. In vitro dental plaque was assessed after brushing the facial surface with one of the three dentifrice products using a clinical plaque scoring index. RESULTS: The area coverage method demonstrated that both dentifrice products tested covered approximately 70% of the facial tooth surface; the CTTM dentifrice coverage on the lingual tooth surface was significantly higher than the coverage for the CRD dentifrice. With the interproximal plaque control method, in the presence of an active ingredient, the CTTM dentifrice had equivalent efficacy to the CTD dentifrice. Both CTTM and CTD were significantly superior to the CRD for interproximal dental plaque control. CONCLUSION: Using the developed tooth model, two assessment methods have been shown to have the potential to demonstrate tooth surface coverage, and to assess the potential efficacy of a dentifrice for the control of interproximal dental plaque. This process can indicate potential clinical evaluation of an oral care product, and support clinical findings with controlled evidence.

Bacteria↗

[Clinical study of the anti-calculus effect of a dentifrice containing sodium polyphosphate].

A double-blind clinical study was conducted to evaluate the effect of a tartar-control dentifrice containing 1% sodium polyphosphate as tartar control agent compared with dentifrice A containing 5% sodium pyrophosphate and a placebo dentifrice. One hundred forty-eights who continued to have a degree of calculus formation after using a regular dentifrice containing no tartar control agent for 1 month in the pretest, were stratified randomly on the basis of pretest, calculus score, age and sex into 3 homogeneous groups. All subjects who received initial prophylaxis were provided the assigned dentifrice and toothbrush. No instructions regarding frequency or method of toothbrushing were allowed. Assessment of supragingival calculus was made at 4 and 12 weeks using the calculus scoring procedure proposed by Volpe et al. Side effects such as oral irritation, ablation of oral mucosa and discoloration of teeth caused by dentifrices were also diagnosed after 12 weeks of use. The following results were obtained in this study. 1. The test dentifrice had reduced (P less than 0.01) supra-gingival calculus significantly more than dentifrice A and the placebo at 12 weeks. 2. A significant reduction (P less than 0.01) was observed when dentifrice A was compared with the placebo dentifrice. 30.1% reduction was obtained using the test dentifrice and 9.0% reduction using dentifrice A when assessed in subjects who had a pretest VMI score of more than 6.0. 3. No side effects caused by the dentifrice which contained sodium polyphosphate were observed.

Dental Calculus↗

Efficacy of a dentifrice containing zinc citrate for the control of plaque and gingivitis: a 6-month clinical study in adults.

The objective of this 6-month, double-blind, clinical study, conducted in harmony with American Dental Association (ADA) guidelines, was to evaluate the efficacy of a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base (zinc citrate dentifrice) for the control of supragingival plaque and gingivitis, compared to a control dentifrice containing 0.76% sodium monofluorophosphate in a silica base (control dentifrice). Adult men and women from the Atlanta, Georgia, area were entered in the study and stratified into two treatment groups, which were balanced for baseline Quigley-Hein Plaque Index scores and baseline Löe-Silness Gingival Index scores. Participants received an oral prophylaxis and were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for supragingival plaque and gingivitis were conducted after 3 months and again after 6 months' use of the study dentifrices. Ninety-nine participants complied with the protocol and completed the entire 6-month clinical study. At both the 3- and 6-month study examinations, the zinc citrate dentifrice group exhibited statistically significant reductions in both plaque and gingivitis compared to the control dentifrice group, based on whole-mouth data. At the 6-month examination, the magnitude of these reductions met or exceeded 18% for both plaque and gingivitis (25.3% for plaque; 18.8% for gingivitis). The effect of the zinc citrate dentifrice was most pronounced on the more severe manifestations of plaque and gingivitis, indicating a statistically significant (50.2%) reduction in severe plaque and a statistically significant (66.7%) reduction in severe gingivitis over the control dentifrice after 6 months of use. Similar findings were observed for data obtained from proximal, lingual, and posterior sites. Among the sites that indicated a tendency toward high levels of plaque or gingivitis based on the baseline scores, substantially fewer sites tended to continue to present such high levels at follow-up exams in the zinc citrate dentifrice group than in the control dentifrice group. Thus, in accordance with the 1986 guidelines published by the ADA and the 1994 revision published by the Task Force on Design and Analysis in Dental and Oral Research, the results of this study support the conclusion that a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base is clinically efficacious for the control of supragingival plaque and gingivitis.

Adolescent↗

Comparative tooth whitening and extrinsic tooth stain removal efficacy of two tooth whitening dentifrices: six-week clinical trial.

OBJECTIVE: The objective of this six-week, examiner-blind clinical study was to assess the tooth whitening and extrinsic tooth stain removal efficacy of a new dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base (Test Dentifrice), relative to that of commercially available hexametaphosphate-containing whitening dentifrice (Positive Control Dentifrice). METHODOLOGY: Following a baseline oral soft tissue examination and scoring of extrinsic tooth stain and tooth shade, qualifying adult male and female subjects from the Harrisburg, Pennsylvania area were randomized into either the Test or Positive Control Dentifrice group. The two groups were balanced for gender, extrinsic tooth stain, and tooth shade scores. All subjects were provided their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for two minutes twice daily (morning and evening) using only the dentifrice provided, and to refrain from using any other oral hygiene products for the entire six weeks of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Oral soft tissue, extrinsic tooth stain, and tooth shade assessments for each subject were repeated after two and six weeks of product use. All statistical tests were two sided and employed a level of significance of alpha = 0.05. RESULTS: Fifty-six (56) subjects complied with the protocol and completed the entire study. Compared to baseline at both the two- and six-week examinations, the Test Dentifrice group had statistically significant reductions in extrinsic tooth stain area and intensity, and statistically significant mean shade rank reductions, with a six-week reduction of 4.81. In contrast, at six weeks, the Positive Control dentifrice had a statistically significant increase in tooth stain area, a non-significant increase in tooth stain intensity, and a statistically significant mean 1.40 shade rank score reduction. At both the two- and six-week examinations, the Test Dentifrice group had statistically significantly lighter tooth shades and statistically significantly lower levels of extrinsic tooth stain area and intensity than the Positive Control Dentifrice group. CONCLUSION: A new whitening dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride, and sodium tripolyphosphate in a high-cleaning silica base has significant efficacy in tooth whitening and extrinsic stain removal, and provides a statistically significantly greater level of efficacy for both tooth whitening and extrinsic tooth stain removal than the commercially available Positive Control Dentifrice.

Adolescent↗

Extrinsic tooth stain removal efficacy of a sodium bicarbonate dual-phase dentifrice containing calcium and phosphate in a six-week clinical trial.

OBJECTIVE: The objective of this clinical investigation was to evaluate the effectiveness in removing existing extrinsic tooth stains of a sodium bicarbonate (baking soda), dual-phase dentifrice containing calcium and phosphate (Test Dentifrice), when compared to a commercial hydrated silica dentifrice (Control Dentifrice), during a six-week period of normal, unsupervised use. METHODOLOGY: This investigation was a double-blind comparison of two equivalent, parallel groups of subjects assigned to use different dentifrices for six weeks. A total of 108 adult male and female subjects qualified for the trial based on the presence of existing extrinsic tooth stains and other inclusion/exclusion criteria. The two groups were balanced for gender, tobacco use, and extrinsic tooth stain scores, and randomly assigned the Test or Control dentifrices. All subjects were instructed to brush their teeth twice daily using only the dentifrice and toothbrush provided, and to refrain from using any other oral hygiene products for the duration of the study. Although product usage was unsupervised after the baseline visit, subjects maintained a treatment diary, and product consumption was monitored to estimate compliance. Oral soft and hard tissue and extrinsic stain assessments (Modified Lobene Stain Index) for each subject were conducted at baseline and after two, four, and six weeks of product use. RESULTS: A total of 107 subjects complied with the protocol and completed the six-week study. Compared to baseline, at the two-, four-, and six-week examinations the Test Dentifrice group had statistically significant reductions in extrinsic tooth stain. In contrast, the Control Dentifrice group did not attain significant reductions from baseline at any of the exams. At both the four-week and six-week examinations, the Test Dentifrice group had significantly lower levels of extrinsic tooth stain than the Control Dentifrice group. CONCLUSION: A sodium bicarbonate, dual-phase dentifrice containing calcium and phosphate demonstrated statisically significant efficacy in removing naturally acquired, extrinsic tooth stain, and was significantly more effective for stain removal than a commercially available, hydrated silica dentifrice.

Adult↗

Effect of a triclosan/copolymer/fluoride dentifrice on plaque formation and gingivitis: a 7-month clinical study.

A total of 108 adult male and female subjects completed a 7-month, double-blind clinical study designed to compare the effect of a dentifrice containing 0.3% triclosan and 2% of a copolymer of methoxyethylene and maleic acid on plaque formation and gingivitis, as compared to a placebo dentifrice. The subjects were stratified into two balanced groups according to baseline plaque and baseline gingivitis scores. They then received an oral prophylaxis and were assigned to the use of either a placebo dentifrice or the triclosan/copolymer dentifrice for the next 7 months. After this time, the dentifrice containing triclosan/copolymer provided a 58.96% statistically significant (99% level of confidence) reduction in plaque [corrected], as compared to the placebo dentifrice. Further, after 7-months' use, the dentifrice containing triclosan/copolymer also provided a 30.17% statistically significant (99% level of confidence) reduction in gingivitis as compared to the placebo dentifrice. The results after 7 months also indicated that the dentifrice containing triclosan/copolymer provided a 97.74% statistically significant (99% level of confidence) reduction in the supragingival plaque deposits on those tooth surfaces with the greatest amount of plaque formation, when compared to the placebo dentifrice. The dentifrice containing triclosan/copolymer also provided 87.56% less sites with the most severe amount of gingival disease, as compared to the placebo dentifrice. This decrease in diseased gingival sites was statistically significant at the 99% level of confidence. It was concluded that the twice daily use of a dentifrice containing 0.3% triclosan and 2% of a copolymer reduces supragingival plaque deposit formation and gingivitis to a highly significant degree, without any extrinsic stains observed.

Adult↗

The effect of a dentifrice containing triclosan and a copolymer on plaque formation and gingivitis: a 14-week clinical study.

One hundred eighteen male and female adult subjects were entered into a 14-week, double-blind clinical study to compare the effect of a dentifrice containing 0.3% triclosan and 2% of a copolymer of methoxyethylene and maleic acid on plaque formation and gingivitis. The subjects were stratified into two balanced groups according to baseline plaque scores. They then received an oral prophylaxis and were assigned to the use of either a placebo dentifrice or the triclosan/copolymer dentifrice for the next 14 weeks. After 6 weeks' use, the triclosan/copolymer dentifrice provided a 21.34% statistically significant (99% level of confidence) reduction in supragingival plaque deposits, as compared to the placebo dentifrice. The triclosan/copolymer dentifrice also provided a 5.49% reduction gingivitis after 6 weeks' use, as compared to the placebo dentifrice. This reduction was not statistically significant. After 14 weeks' use, the triclosan/copolymer dentifrice provided a 38.80% statistically significant (99% level of confidence) reduction in supragingival plaque deposits, as compared to the placebo dentifrice. The dentifrice containing triclosan and copolymer also provided 50.72% statistically significant (99% level of confidence) reduction in gingivitis, as compared to the placebo dentifrice. When tooth surfaces with the highest degree of plaque formation (i.e. Quigley-Hein score greater than or equal to 3) were examined at 6 weeks, the triclosan/copolymer dentifrice provided a 42.92% statistically significant (99% level of confidence) reduction in supragingival plaque deposits, as compared to the placebo dentifrice.(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗

Anticalculus efficacy of three dentifrices.

PURPOSE: To evaluate the anticalculus effect of three commercial dentifrices. MATERIALS AND METHODS: A 12-week independent and double-blind clinical study was conducted on a population of calculus-forming adult male and female subjects in Budapest, Hungary to directly compare the anticalculus efficacy of three commercially-available dentifrices, as compared to a placebo dentifrice. The three commercially-available anticalculus dentifrices compared in this clinical study to a 0.243% sodium fluoride/silica placebo dentifrice were as follows: (1) A dentifrice containing 1.3% soluble pyrophosphate and 1.5% of a PVM/MA copolymer in a 0.243% sodium fluoride/silica base. (2) A dentifrice containing 0.3% triclosan and 2% of a PVM/MA copolymer in a 0.243% sodium fluoride/silica base. (3) A dentifrice containing 0.3% triclosan and 0.75% zinc citrate in a 1.14% sodium monofluorophosphate/silica base. RESULTS: All three anticalculus dentifrices provided statistically significant reductions in supragingival calculus formation, as compared to a placebo dentifrice, after 12 weeks of use. The reductions in supragingival calculus formation ranged from 39% to 55%, as compared to a placebo dentifrice, for the three commercially-available anticalculus dentifrices. There was no statistically significant difference among the three commercially-available dentifrices with regard to anticalculus efficacy.

Adult↗

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.

Adult↗

Development of an enhanced anticaries efficacy dual component dentifrice containing sodium fluoride and dicalcium phosphate dihydrate.

A dual-chamber dentifrice, which contains sodium fluoride (NaF) in one component and dicalcium phosphate dihydrate (dical) in the other, has been developed. The dentifrice is packaged in a dual-chamber tube and is formulated to deliver 1100 ppm F. A series of studies consisting of in vitro fluoride uptake, in vivo calcium labeling, intraoral remineralization-demineralization, and animal caries studies were performed to support the improved anticaries efficacy of this product in comparison to a sodium fluoride/silica dentifrice (NaF/silica). An in vitro fluoride uptake study comparing 1100 ppm F NaF/dical dentifrice to 1100 ppm F NaF/silica showed that NaF/dical delivered significantly more fluoride than NaF/silica, 3.72 +/- 0.36 micrograms/cm2 versus 2.41 +/- 0.10 micrograms/cm2. A 6-day in vivo brushing study with a 44Ca labeled NaF/dical dentifrice showed that calcium from dical penetrated demineralized enamel and was present in plaque up to 18 hrs since the last brushing. An intra-oral remineralization-demineralization study was performed to evaluate NaF/dical's ability to promote remineralization in comparison to three silica-based dentifrices containing 0, 250, and 1100 ppm F as NaF. The percent mineral changes after treatment were +20.44 +/- 17.14 for NaF/dical, +9.27 +/- 19.53 for 1100 ppm NaF/silica, -1.43 +/- 20.57 for 250 ppm NaF/silica, and -12.36 +/- 32.76 for 0 ppm F/silica. A statistical analysis showed that the dual-chamber NaF/dical dentifrice was significantly more effective than the 1100 ppm NaF/silica dentifrice at promoting remineralization. A rat caries study was performed to evaluate NaF/dical ability to prevent caries in comparison to 1100 ppm F NaF/silica, 250 ppm F NaF/silica, silica, and dical dentifrices. The mean smooth surface caries scores were 1.6 +/- 2.8 for NaF/dical, 5.5 +/- 6.2 for 1100 ppm F NaF/silica, 10.6 +/- 6.2 for 250 ppm F NaF/silica, 13.7 +/- 4.7 for 0 ppm F/silica, and 9.5 +/- 7.8 0 ppm F/dical. A statistical analysis showed that the the dual-chamber NaF/dical dentifrice was superior to all other treatments tested in preventing caries in rats. The dical dentifrice was significantly superior to the silica dentifrice in preventing caries, which indicates that dical alone exhibits anticaries efficacy. In conclusion, individual and cumulative results from the fluoride uptake, intra-oral remineralization-demineralization, and rat caries studies from the dual chamber NaF/dical dentifrice support the improved anticaries efficacy of this product.

Animals↗

Fluoride availability in human saliva after dentifrice use: correlation with anticaries effects in rats.

Studies were conducted to determine fluoride availability in saliva after dentifrice use and to relate this parameter to cariostatic efficacy in rat caries experiments. Three dentifrices--two commercial formulations (Colgate Winterfresh Gel and Crest Dentifrice with Na-Sr-polyacrylate) and an Experimental dentifrice--were compared with respect to salivary fluoride availability. All of the dentifrices tested contained 1100 ppm F as sodium fluoride. It was observed that the Experimental dentifrice and Crest dentifrice with Sr-polyacrylate exhibited low salivary fluoride availability relative to the Colgate Winterfresh Gel. Salivary fluoride availability was assessed by means of two parameters: (a) the fluoride concentration in the dentifrice saliva slurry expectorated after brushing, and (b) the area under the curve of salivary F concentration vs. time for up to two hours after dentifrice use. In two rat caries experiments, it was observed that both the Experimental dentifrice and the Sr-polyacrylate dentifrice provided less cariostatic efficacy than the clinically validated Positive Control (Colgate Winterfesh Gel). Analysis of these data provides further evidence in support of the concept that fluoride availability in saliva following dentifrice use is an important parameter related to anticaries efficacy.

Acrylic Resins↗

Studies on plaque fluoride after use of F-containing dentifrices.

Increased fluoride levels in plaque and saliva have been associated with improved protection against dental caries for dentifrices which contained sodium monofluorophosphate (Duckworth et al., 1992). The main aim of the present work was to test whether oral fluoride retention depended on F source after use of dentifrices containing either NaF or Na2FPO3. In study 1, plaque samples were collected from 474 subjects who had been using one of six test dentifrices for two years, and analyzed by F extraction with water. The dentifrices contained 1000 or 1500 micrograms F/g as either NaF or Na2FPO3. Significantly more fluoride was found in plaque from subjects who were using the NaF dentifrices than in plaque from subjects who were using Na2FPO3 dentifrices of the same F content. Subsets of plaque samples were large enough to divide into two parts for extraction by both acid and water. No significant difference was found between mean fluoride contents, indicating that the majority of fluoride retained in plaque from these conventional dentifrices appears to be relatively labile. The results of two small-scale human enamel studies showed that NaF dentifrices gave elevated F concentrations in plaque and saliva, respectively, compared with Na2FPO3 dentifrices of equivalent F content, consistent with the main plaque study 1. These findings demonstrate that oral F retention from dentifrices is dependent on the source of ionic fluoride and support the view that NaF dentifrices may be more clinically effective than dentifrices which contain the same amount of F as Na2FPO3.

Adolescent↗

Clinical comparison of anticalculus dentifrices: a three-month study of Thai children and teenagers.

A three-month, double-blind, parallel clinical study was conducted to evaluate the effects of three dentifrices on supragingival calculus formation. The products tested were a pyrophosphate/Gantrez copolymer, silica based dentifrice containing 0.243% sodium fluoride, a zinc citrate dentifrice containing 1.2% sodium monofluorophosphate in an alumina abrasive system, and a sodium fluoride/silica based placebo dentifrice. Using baseline Volpe-Manhold calculus scores, 150 Thai elementary school children in Chonburi Province were stratified into three balanced groups. All children then received a whole mouth oral prophylaxis and were randomly assigned one of the three test dentifrices. The children used only their assigned dentifrice for the next three months. At the end of three months, the study dentifrice containing pyrophosphate/copolymer reduced supragingival calculus deposits by 35% compared to the placebo dentifrice. This reduction was statistically significant at p less than .01. The pyrophosphate/copolymer dentifrice was also significantly better than the zinc citrate dentifrice at the p less than .01 level in reducing calculus scores. The zinc citrate dentifrice scores were not found to be significantly different from the placebo dentifrice scores on calculus reduction.

Adolescent↗

Daily use of dentifrice with and without xylitol and fluoride: effect on glucose retention in humans in vivo.

The effect of daily use of three different dentifrices on glucose retention after glucose mouth rinsing was tested in this study regarding xylitol and fluoride. Six experimental groups used three different dentifrices produced by two different companies: xylitol- and fluoride-containing dentifrice (XF), non-xylitol- and fluoride-containing dentifrice (F), and non-xylitol- and non-fluoride-containing dentifrice (NonX-NonF). Subjects were divided at random and rinsed their mouths for 15s with 20ml of 0.5M glucose solution. Glucose and lactate retention were determined by collecting samples of saliva from the approximal areas of the maxillary and mandibular anterior teeth and using the enzyme membrane test. Samples were collected 0, 1 and 2 months after the start of regular dentifrice use. There were significant differences in glucose retention in relation to the dentifrice used, month of sampling, site of sampling, and time since start of rinsing. Their contribution ratios were 2.0, 4.4, 11.7 and 7.4%, respectively (P<0.01). There were significant differences observed between the XF and NonX-NonF groups, with the XF group presenting lower glucose retention than the NonX-NonF group. The XF group presented lower glucose retention than the F group. The F group showed lower glucose retention than the NonX-NonF group. There were significant differences in lactate retention in relation to the month and site of sampling, and their contribution ratios were 3.3 and 2.8%, respectively (P<0.01). There were, however, no significant differences in glucose and lactate retention in relation to the dentifrice manufacturer. It was concluded that the XF dentifrice was the most effective, and the F dentifrice was more effective in reducing glucose retention than the NonX-NonF dentifrice.

Adult↗

Evaluation of ketorolac concentrations in plasma and gingival crevicular fluid following topical treatment with oral rinses and dentifrices.

Two clinical studies were conducted to determine the relative amounts of ketorolac detectable locally in the gingival crevicular fluid (GCF) and systemically in plasma after oral, topical drug administration. The rinse study compared topical administration of three concentrations of ketorolac tromethamine (0.1%, 0.5%, and 0.01%) in oral rinse formulations administered topically and a perorally administered capsule (10 mg), and the dentifrice study compared two concentrations of ketorolac in dentifrice formulations (0.15% and 1.0%) with a 0.1% oral rinse, all treatments administered topically. The dose-corrected systemic availability of the three oral rinses evaluated in the rinse study relative to the peroral capsule was about 15%. However, the ratios of the observed maximum GCF ketorolac concentration to maximum plasma ketorolac concentration ranged from 22 to 49, compared to less than 1 for the peroral ketorolac capsule. Using this ratio as an estimate of the ability of a treatment to target the drug to the gingival tissue, these data indicate that the ketorolac oral rinses achieved greater delivery of drug to the gingival tissue (presumed site of action for periodontitis) with a lower systemic drug load than peroral administration of a ketorolac capsule. The dose-corrected relative systemic bioavailabilities for the dentifrice treatments with respect to the 0.1% rinse in the dentifrice study were 59.2% and 86.4% for the 1.0% and 0.15% dentifrices, respectively, indicating that significantly less ketorolac was systemically available from the two dentifrices relative to the oral rinse. The relative bioavailabilities of ketorolac in the GCF after dosing with the dentifrice formulations with respect to the rinse were 89.1% for the 1.0% dentifrice and 19.7% for the 0.15% dentifrice. Thus, the 1.0% dentifrice appears to provide statistically equivalent levels of ketorolac to the gingival tissue as the 0.1% oral rinse with significantly less systemic exposure. The T1/2 of ketorolac in the GCF was about 0.5 h for all three treatments, which is significantly less than the plasma half-life of about 5.3 h. These data suggest that GCF levels of ketorolac should remain above the IC50 for PGE2-stimulated IL-1 bone resorption for about 7 h following treatment, assuming continuation of the first-order elimination observed over the first two postdosing hours. We conclude that oral rinses and dentifrices are effective and preferred vehicles for administration of ketorolac for use in treatment of periodontitis.

Administration, Topical↗

Effect of a triclosan/PVM/MA copolymer/fluoride dentifrice on volatile sulfur compounds in vitro.

OBJECTIVE: The objective of the investigation was to document the in vitro efficacy of a triclosan/PVM/MA copolymer/fluoride (TCF) dentifrice against the formation of volatile sulfur compounds (VSC) as well as the growth of H2S-producing bacteria. Clinical studies using organoleptic judges, gas chromatography, or a portable sulfide monitor have generally been employed in the assessment of treatments for the control of oral malodor. However, these studies are not appropriate for screening purposes because of the expense and time required. METHODS: An in vitro method was developed for the purpose of screening new compounds, agents or formulations for their ability to control VSC formation and for determining bio-equivalence of efficacy when implementing changes in existing formulations. The method combines basic microbiological methods, dynamic flow cell techniques and head space analysis. The in vitro VSC method was validated by comparing the efficacy of two dentifrices containing TCF with a control fluoride dentifrice as the TCF products have been clinically proven to control oral malodor. RESULTS: In the validation studies, the TCF-containing dentifrices were significantly better (P < 0.05) than the control dentifrice in inhibiting VSC formation and reducing H(2)S-producing bacteria. For example, when compared with baseline, the TCF dentifrices reduced VSC formation between 42 and 49% compared with the control dentifrice which reduced VSC formation 3%. There was no significant difference (P > 0.05) between the two TCF dentifrice formulations. CONCLUSION: Using an in vitro breath VSC model, it has been demonstrated that two variants of a dentifrice containing triclosan, PVM/MA copolymer and fluoride have efficacy that is significantly better than a control fluoridated dentifrice and that there is no significant difference between the triclosan/PVM/MA copolymer/fluoride dentifrice variants.

Actinomyces↗

The antimicrobial potential of 14 natural herbal dentifrices: results of an in vitro diffusion method study.

BACKGROUND: Increasing numbers of Americans are using natural herbal products for general and oral health care. Few of these products, however, have undergone rigorous testing, as evidenced by the limited amount of information on their safety and efficacy in the literature. The authors conducted an in vitro study to evaluate the antimicrobial potential of 14 natural herbal dentifrices. METHODS: The authors used a diffusion method to evaluate the antimicrobial effectiveness of 14 natural herbal dentifrices against four microorganisms: Streptococcus mutans, Streptococcus sanguis, Actinomyces viscosus and Candida albicans. Colgate Total (Colgate-Palmolive, New York City) and sterile pyrogen-free water served as the positive and negative controls, respectively. The authors tested the natural herbal dentifrices at full strength and at 1:1 dilution. They measured the zones of inhibition at 24 and 48 hours to evaluate the antimicrobial potential of the dentifrices. RESULTS: Six herbal dentifrices were effective in inhibiting the growth of all four microorganisms. The positive control produced significantly sized inhibition zones with all four microorganisms, while the negative control produced no observable zones. Six herbal dentifrices produced larger inhibition zones with A. viscosus than did the positive control. Six herbal dentifrices were inhibitory against C. albicans at full strength, but at 1:1 dilution, only three had such inhibitory effect. One herbal dentifrice produced microbial growth around and over the samples, indicating possible microbial contamination of the toothpaste. Only one herbal dentifrice showed consistent antimicrobial activity against all four microorganisms. CONCLUSIONS: The variation in antimicrobial inhibition among the herbal dentifrices indicates that more research is needed to validate their effectiveness claims. CLINICAL IMPLICATIONS: This study provides practitioners with insight into the claims of natural herbal dentifrices' antimicrobial effects.

Actinomyces viscosus↗

Additional effect of dentifrices on the instant efficacy of toothbrushing.

BACKGROUND: Inconclusive evidence exists in the literature with regard to the additional effect of the use of dentifrice on plaque removal. The present study was undertaken to test whether the use of dentifrice during toothbrushing contributes to the instant cleaning efficacy of the brushing procedure. METHODS: Three groups of patients, 40 subjects each, were randomly assigned to one of three dentifrices that differed with respect to the relative dentin abrasivity (RDA) value. After a 48-hour plaque accumulation, subjects brushed under supervision in a split-mouth order with or without the use of dentifrice (total time=2 minutes). RESULTS: Plaque reductions varied between 51% and 58% for the three dentifrices. The overall analysis showed a mean difference of 3% in plaque reduction in favor of brushing without dentifrice (P=0.017). The type of dentifrice did not influence this observed difference (P=0.506). Also, the order of the brushing procedure (starting the brushing procedure with or without dentifrice) had no interaction with the effect of dentifrice on the brushing (P=0.187). CONCLUSIONS: The use of dentifrice does not contribute to the instant mechanical plaque removal during manual toothbrushing. A higher dentifrice abrasivity does not seem to contribute to increased plaque removal with a manual toothbrush. It appears that the mechanical action provided by the use of a toothbrush is the main factor in the plaque-removing process.

Adult↗