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PubMed1993

A critical review of the 10 pivotal caries clinical studies used in a recent meta-analysis comparing the anticaries efficacy of sodium fluoride and sodium monofluorophosphate dentifrices.

The 10 pivotal caries clinical studies employed in a recent meta-analysis to compare the anticaries efficacy of sodium fluoride (NaF) and sodium monofluorophosphate (MFP) dentifrices were subjected to a critical review. When reporting the meta-analysis, the author (Johnson) considered these 10 pivotal caries clinical studies as "head-to-head" comparisons of NaF and MFP dentifrices. For the most part, it is difficult to find any common denominator among these 10 caries clinical studies since there were so many diverse factors associated with them. The 10 pivotal studies were conducted over a 20-year period of time in many different geographic areas of the world, using different protocols and study designs, different clinical examiners and caries assessment criteria, as well as evaluating commercially outdated or specially formulated dentifrices. Any attempt to integrate the results from these 10 studies is further complicated by the diversity of statistical methodology used to evaluate the results obtained from the studies. Also, in two of the 10 studies, the comparison of the fluoride dentifrices was obscured by the fact that the participating children used a fluoride mouthrinse during the course of the study. In any case, when all relevant dentifrice comparisons are made, the results of a critical review of the 10 pivotal ("head-to-head") caries clinical studies indicate the following: (1) In three of the studies (Gerdin/Zacherl/Forsman), depending upon how the data is viewed, it can either be shown that NaF dentifrices are favored over MFP dentifrices or that MFP dentifrices are favored over NaF dentifrices. (2) In one of the studies (Edward & Torell), the results are published only in abstract form and a full report of the study is not available. (3) In one of the studies (Koch, Petersson, Kling & Kling) it is reported that MFP dentifrices are favored over NaF dentifrices. (4) In two of the studies (Edlund & Koch, Koch et al) it is reported that NaF dentifrices are favored over MFP dentifrices. However, in both of these studies, there were serious imbalances in baseline caries status favoring the NaF dentifrice groups over the MFP dentifrice groups. In other words, the children using the MFP dentifrices were more prone to caries formation during the course of these studies than the children using the NaF dentifrices. Further, in these two studies there is a serious question regarding the soluble fluoride level of the commercially available MFP dentifrice that was used.(ABSTRACT TRUNCATED AT 400 WORDS)

Adolescent↗
PubMed2001

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in the United States of America.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 5-17 yr-old children from the Central and South areas of Florida and from the Lares area of Puerto Rico. Qualifying subjects were stratified according to age and sex, and 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 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 enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand five hundred six (2,506) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 2.29 for the Test Dentifrice group, and 2.47 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 0.69 for the Test Dentifrice group and 0.81 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 1.25 for the Test Dentifrice group, and 1.46 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 14.38% reduction in caries increment scores at 2 yrs. 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 the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

Adolescent↗
PubMed2001

The enhanced anticaries efficacy of a sodium fluoride and dicalcium phosphate dihydrate dentifrice in a dual-chambered tube. A 2-year caries clinical study on children in Brazil.

PURPOSE: To clinically evaluate and compare a dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate (Test Dentifrice delivering 0.243% sodium fluoride), to a dentifrice containing 0.243% sodium fluoride in a silica base (Positive Control Dentifrice). MATERIALS AND METHODS: This study was conducted in harmony with the published 1988 American Dental Association guidelines for studies geared toward the comparison of fluoride dentifrices. This 2-yr caries clinical study employed a double-blind, parallel-group design, and involved 6-10 yr-old children from the metropolitan area of Maceio, Alagoas, Brazil. Qualifying subjects were stratified according to age and sex, and 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. One calibrated examiner performed all 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 enforce compliance with the study. Post-baseline examinations were performed after 1 yr of product use, and again after 2 yrs of product use. RESULTS: Two thousand four hundred thirty-two (2,432) subjects completed this 2-yr study. For these subjects, the mean caries scores (DMFS, decayed, missing and filled tooth surfaces) at baseline were 3.84 for the Test Dentifrice group, and 4.06 for the Positive Control Dentifrice group. For caries increments after 1 yr, the respective means were 2.02 for the Test Dentifrice group and 2.12 for the Positive Control Dentifrice group. Finally, after 2 yrs, the mean caries increments were 4.30 for the Test Dentifrice group, and 4.83 for the Positive Control Dentifrice group. No statistically significant difference was indicated between the treatment groups at baseline or between the 1-yr caries increment scores. However, there was a statistically significant difference in the 2-yr caries increment scores between the treatment groups. Relative to the Positive Control Dentifrice group, the Test Dentifrice group presented a 10.97% reduction in caries increment scores at 2 yrs. 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 the dentifrice system in a dual-chambered tube, wherein one chamber contained sodium fluoride in a silica base and the other chamber contained dicalcium phosphate dihydrate, delivering 0.243% sodium fluoride, provided a superior level of anticaries efficacy than did the dentifrice containing 0.243% sodium fluoride in a silica base.

Brazil↗
PubMedDate not supplied

Analysis of fingernails and urine as biomarkers of fluoride exposure from dentifrice and varnish in 4- to 7-year-old children.

The use of fingernails and urine as biomarkers of exposure to fluoride (F) from fluoridated dentifrice and varnish was evaluated in twenty 4- to 7-year-old children, who were divided into two groups: group A (9 caries-free children) and group B (11 children with past caries experience). They used a placebo dentifrice for 28 days, fluoridated dentifrice (1,570 ppm F) for the following 28 days, and placebo dentifrice for an additional 28 days, then returned to their usual dentifrices. Group B children also received 4-week applications of a varnish (2.26% F) while using the fluoridated dentifrice. Urinary collections were performed 24 h before the use of fluoridated dentifrice and 24 h (group A) or 48 h (group B) after. Fingernails were clipped every 2 weeks, for 26 weeks. Total F intake from diet and dentifrice was estimated. Fingernail F concentrations did not vary significantly throughout the study. Twenty-four-hour urinary F outputs (mean +/- SD, microg) were: 414 +/- 200 and 468 +/- 253 for placebo and F dentifrices, respectively (group A) and 402 +/-206, 691 +/- 345, 492 +/- 243 for placebo dentifrice, F dentifrice plus F varnish and F dentifrice, respectively (group B). The use of F dentifrice did not cause a significant increase in the urinary F output. However, when F varnish was used, a transitory increase in the urinary F output was detected (p = 0.001), returning to baseline levels in the last 24 h. Thus, F varnish is a safe method for topical F application even in children that use F dentifrice regularly. According to our protocol, urine was a suitable biomarker of exposure to F from dentifrice plus varnish, but not from dentifrice alone, while nails were not.

Analysis of Variance↗
PubMed1998

Laboratory assessment of tooth whitening by sodium bicarbonate dentifrices.

The increasing emphasis on dental aesthetics has made tooth whitening an important function of a dentifrice. This laboratory study investigated the whitening effect of toothbrushing with sodium bicarbonate-based dentifrices compared with standard dentifrices that do not contain sodium bicarbonate. Six dentifrices and a distilled water control were tested for their ability to whiten teeth with intrinsic stain. The dentifrices contained different abrasive systems: (1) 45% NaHCO3; (2) 65% NaHCO3 (Arm and Hammer Dental Care); (3) 94% NaHCO3; (4) 94% NaHCO3 + 1.5% H2O2; (5) silica (Crest Regular Toothpaste); and (6) dicalcium phosphate (Colgate Regular Toothpaste). After a thorough rubber cup cleaning with a pumice slurry, the intrinsic color of the test teeth with a Vita shade of A3 or darker was measured with a spectrophotometer using the standard L*a*b* color scale. Measurements were taken on a total of 12 teeth per test dentifrice before treatment, and after 30, 60, 90 and 120 minutes of mechanical toothbrushing. No changes in L* (lightness/brightness) or a* (red-green hue) occurred, but significant differences in b* (yellow-blue hue) were observed over time. Compared to baseline tooth color, all four sodium bicarbonate-based dentifrices were significantly effective in removing the yellow intrinsic tooth stain, while the water control, silica dentifrice, and dicalcium phosphate dentifrice demonstrated no significant change. Between-group comparisons showed that the four dentifrices containing sodium bicarbonate were significantly more effective than the water and dicalcium phosphate dentifrice groups. The commercial dentifrice containing 65% sodium bicarbonate was also more effective than the commercial silica dentifrice. Although continued toothbrushing from 30 to 120 minutes resulted in additional stain removal, most of the tooth whitening by the sodium bicarbonate-based dentifrices occurred in the first 30 minutes of brushing. In the studies conducted, dentifrices containing high concentrations of sodium bicarbonate were more effective at removing intrinsic tooth stain than dentifrices that do not contain sodium bicarbonate.

Dentifrices↗
PubMed1997

The comparative clinical efficacy of pyrophosphate/triclosan, copolymer/triclosan and zinc citrate/triclosan dentifrices for the reduction of supragingival calculus formation.

Three triclosan-containing "multi-benefit" dentifrices were compared for clinical efficacy in reducing supragingival calculus formation following a dental prophylaxis. A total of 544 subjects completed a double-blind parallel-group clinical study using the Volpe-Manhold Index (VMI) to record severity and occurrence of supragingival calculus. The study design included a pre-test period where the calculus formation rate was measured in subjects brushing with a placebo dentifrice. Following a prophylaxis, subjects were stratified for age, gender and VMI scores and assigned to one of four treatments: 1) a dentifrice containing 5.0% soluble pyrophosphate/0.145% fluoride as NaF/silica abrasive/0.28% triclosan (hereafter PPi/TCS-comparable to Crest Complete dentifrice, Procter & Gamble, UK); 2) a commercial dentifrice containing 2.0% Gantrez acid copolymer/ 0.145% fluoride as NaF/silica abrasive/0.30% triclosan (hereafter Gan/TCS-Colgate Total dentifrice, Colgate-Palmolive Company, UK); 3) a commercial dentifrice containing 0.5% zinc citrate trihydrate/0.15% fluoride as sodium monofluorophosphate/silica abrasive/0.20% triclosan (hereafter Zn/TCS-Mentadent P dentifrice, Unilever, UK); and 4) a control dentifrice comprised of 0.145% fluoride as NaF/silica abrasive (hereafter Control). Subjects were instructed to use their assigned dentifrice at least twice per day and to brush as they do normally. Supragingival calculus formation was assesed at two and four months using site-specific and whole-mouth VMI indices for both calculus severity and occurrence. Following four months of use, the PPi/TCS dentifrice provided statistically significant reductions in calculus severity (22-23%) and occurrence (15%) as compared with the Control dentifrice. The Zn/TCS dentifrice also provided significant reductions in calculus severity (17-19%) and occurrence (12-13%) as compared with the Control. The Gan/TCS produced no statistically significant reductions in calculus formation (occurrence or severity) compared with the Control. The PPi/TCS dentifrice provided statistically significant reductions in calculus severity (15-21%) and occurrence (12-16%) as compared with the Gan/TCS dentifrice. These results support the clinical effectiveness of PPi/TCS and Zn/TCS dentifrices for the reduction of supragingival dental calculus formation following a dental prophylaxis.

Adolescent↗
PubMed2002

Triclosan/pyrophosphate dentifrice: dental plaque and gingivitis effects in a 6-month randomized controlled clinical study.

A double-blind, parallel, randomized and controlled clinical trial was conducted on 186 subjects over six months to assess the effects of a 0.28% triclosan/5% pyrophosphate (with NaF/silica) dentifrice on dental plaque and gingivitis as compared to a NaF/silica negative control dentifrice. An initial examination was performed to assess the health of the oral soft and hard tissues and to measure plaque (by Turesky modified Quigley-Hein Plaque Index), gingivitis (by Löe-Silness Gingival and Ainamo and Bay Gingival Bleeding [GBI] indices). Only those subjects with a GBI score > or = 5 were accepted into the study. Each enrolled subject received an oral prophylaxis and was requested to brush and floss twice per day with the negative control NaF/silica dentifrice. After one month, the subjects were recalled and a baseline examination was performed for each of the previously described parameters. Following the baseline examination, the subjects received another oral prophylaxis. The subjects were then separated by gender and by baseline GBI scores of < or = 7 or > 7 and arrayed by the changes in GBI bleeding sites from initial to baseline. Within strata, subjects were randomly assigned to brush twice per day with either the triclosan/pyrophosphate dentifrice or the negative control dentifrice. The subjects were subsequently examined for all of the above-described parameters following use of the test dentifrices for five weeks, three and six months. The data generated in this trial were analyzed using an analysis of covariance on all indices for all subjects completing the examinations. The results from this study demonstrated that the use of the triclosan/pyrophosphate dentifrice resulted in statistically significant reductions of dental plaque compared to the control by 10% (p < 0.05), 15.4% (p < 0.01) and 13.9% (p < 0.01) at five weeks, three and six months, respectively. However, there were no statistically significant differences between the test dentifrices for any of the gingivitis or gingival bleeding evaluations throughout the study. Based on 1) the fact that subjects possessed plaque-induced gingivitis in this clinical study, 2) the similarity in the magnitude of the plaque reductions observed from the triclosan/pyrophosphate dentifrice relative to those reported for other triclosan-containing dentifrices, 3) the similarity in the dose of triclosan relative to other triclosan dentifrices, and 4) the reported magnitude of gingivitis reductions from other triclosan-containing dentifrices, these findings were unexpected. Possible explanations of these results are that the triclosan/pyrophosphate dentifrice may be uniquely different from other triclosan dentifrices relative to its effects on gingivitis, or alternatively, the clinical design utilized here may not be optimized for triclosan/pyrophosphate dentifrice.

Adolescent↗
PubMed2001

Comparative investigations of the desensitising efficacy of a new dentifrice.

OBJECTIVES: In two clinical trials of 8 weeks duration, the ability of a new dentifrice, containing potassium nitrate, stannous fluoride and sodium fluoride to reduce dentine hypersensitivity was compared with either a non-desensitising fluoride dentifrice or a commercially available desensitising dentifrice (Sensodyne F) to reduce dentine hypersensitivity. METHOD: In both studies, the participants had to have at least two sensitive root surfaces. Subjects were stratified by baseline tactile and air blast sensitivity scores and the number of sensitive teeth and randomly allocated to 2 balanced groups. In the first study (N=81) the new dentifrice was compared with a fluoride dentifrice and in the second study (N=105) with Sensodyne F. Participants were requested to brush with their assigned dentifrice twice a day for one minute. At 4 and 8 weeks the sensitive teeth were again examined and their tactile and air blast sensitivity scores recorded. RESULTS: In study 1, the group using the new dentifrice tolerated greater pressure after 4 (34.9 g) and 8 weeks (38.4 g) than the group using the fluoride dentifrice (22.9 g and 19.0 g, respectively). These differences were statistically significant (p<0.001). At 4 and 8 weeks, the mean air blast scores for the group using the new dentifrice (1.39 and 0.83) were lower than for the group using fluoride dentifrice (1.78 and 1.76) and were significantly different at 8 weeks (p<0.001). In study 2 the group using the new dentifrice tolerated greater pressure after 4 (40.5 g) and 8 weeks (43.7 g) than the group using Sensodyne F (27.8 g and 33.2 g, respectively). These differences were statistically significant (p<0.001). At 4 and 8 weeks, the mean air blast scores for the group using the new dentifrice (1.10 and 0.67) were significantly lower than the group using Sensodyne F (1.90 and 1.57) (p<0.001). CONCLUSIONS: These studies demonstrate that the new dentifrice, containing potassium nitrate, stannous fluoride and sodium fluoride is significantly better at reducing dentine hypersensitivity than both the dentifrice containing sodium fluoride and the one containing potassium chloride, triclosan and sodium fluoride (Sensodyne F).

Adolescent↗
PubMed2004

The anti-plaque efficacy of a chlorhexidine mouthrinse used in combination with toothbrushing with dentifrice.

BACKGROUND: Although the efficacy of chlorhexidine (CHX) chemically can be affected by the presence of a sodium lauryl sulphate (SLS)-containing dentifrice in the oral cavity, previous data, collected without supervision, showed that the level of plaque inhibition offered by a 0.2% CHX post-brushing rinse in one jaw is not reduced under the influence of toothbrushing with a 1.5% SLS-containing dentifrice in the opposite jaw. OBJECTIVES: The aim of the present study was to investigate, during a 4-day supervised study period, the anti-plaque efficacy of a 0.2% CHX pre-brushing rinse in one jaw, under the influence of toothbrushing in the opposite jaw, either with a SLS-containing dentifrice or with a SLS-free dentifrice. Three different dentifrices were tested. Two of them contained SLS (Colgate Total & Aquafresh Natural Whitening), the other (Zendium) did not. METHODS: The study was an examiner blind, randomised 4-cell, crossover design. It used a 4-day plaque accumulation model to compare under supervision 4 different oral hygiene regimens with a washout period of at least one week. Thirty-five healthy volunteers were enrolled in the study and were randomly assigned to a sequence according to a 4 x 4 Latin square design. At the beginning of each 4-day test period, they received a thorough dental prophylaxis. Plaque was scored in one randomly assigned (upper or lower) jaw, called the study jaw. At the end of the 4-day period the study jaw was used to study the effect of the four regimens on the level of plaque accumulation. The opposite jaw was assigned as the dentifrice jaw and served only to introduce the effect of brushing with a dentifrice in the study model. Four oral hygiene regimens were designed. During the randomly assigned test periods, rinsing with 0.2% CHX and then brushing the dentifrice jaw was performed twice daily. In regimen 1, 2, and 3 the subjects used a dentifrice in the assigned dentifrice jaw being either a dentifrice with SLS (Colgate Total and Aquafresh Natural Whitening) or a SLS-free dentifrice (Zendium). Regimen 4 served as a control during witch subjects only rinsed with 0.2% CHX. No other oral hygiene methods were allowed. After 4 days of undisturbed plaque accumulation, the amount of plaque was evaluated (Lobene et al. 1982, Quigley & Hein 1962, Turesky et al. 1970 modifications). RESULTS: The overall plaque index for regimen 1, 2 and 3 was, respectively, 1.8, 1.8 and 1.9. For regimen 4, the overall plaque index was 1.9. There was no significant difference in plaque accumulation between the four regimens. CONCLUSIONS: Within the present study design, it can be concluded that the anti-plaque efficacy of a pre-brushing 0.2% CHX mouthrinse does not seem to be reduced under the influence of a normal toothbrushing exercise with a dentifrice after rinsing, whether the dentifrice contains SLS or not.

Adult↗