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Clinical efficacy of a dentifrice containing zinc citrate: a 12-week calculus clinical study in adults.

The objective of this double-blind clinical study, conducted following the Volpe-Manhold design for studies of dental calculus, was to investigate the efficacy of a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base (zinc citrate dentifrice) as compared to a control dentifrice containing 0.76% sodium monofluorophosphate in a silica base (control dentifrice). Adult men and women from the Northern New Jersey area were provided a full oral prophylaxis and assigned the use of a control (non-tartar-control) dentifrice for 8 weeks. At the completion of this initial period, participants were assessed for baseline Volpe-Manhold Calculus Index scores, provided another full prophylaxis, and stratified into two treatment groups that were balanced for age, sex, and baseline calculus. Participants 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 dental calculus were again performed after 12 weeks' use of the study dentifrices. Seventy-five participants complied with the protocol and completed the entire study. At the 12-week examination, the zinc citrate dentifrice group exhibited a statistically significant 31.9% reduction in mean Volpe-Manhold Calculus Index score as compared to the control dentifrice group. Thus, the results of this clinical study support the conclusion that a dentifrice containing 2% zinc citrate and 0.76% sodium monofluorophosphate in a silica base is efficacious for the control of the development of supragingival calculus.

Adolescent↗

A six-week clinical efficacy study of three commercially available dentifrices for the removal of extrinsic tooth stain.

The objective of this double-blind clinical study was to compare the extrinsic tooth stain removal efficacy of three commercially available dentifrices: Colgate Platinum Whitening Toothpaste with Fluoride, Aquafresh Advanced Whitening Toothpaste with Fluoride, and Crest Regular Fluoride Toothpaste. Following a baseline examination for extrinsic tooth stain, qualifying adult male and female subjects from the Toronto, Ontario, Canada are were randomized into three treatment groups which were balanced for age, gender, tobacco habits, and level of extrinsic tooth stain using the Lobene Stain Index. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice using a soft-bristled toothbrush. Examinations for extrinsic tooth stain were repeated after six weeks' use of the study dentifrices. One-hundred forty-nine (149) subjects complied with the protocol and completed the entire study. At the six-week examination, subjects assigned to the Colgate Platinum treatment group exhibited statistically significant reductions (p < 0.05) from baseline level with respect to extrinsic tooth stain area (49.4% reduction) and extrinsic tooth stain intensity (52.4% reduction). Statistically significant reductions (p < 0.05) for both extrinsic tooth stain parameters were also exhibited by the subjects assigned to the Aquafresh Whitening treatment group (14.0% reduction for area, 15.5% reduction for intensity). Both tooth whitening treatments provided statistically significantly greater reductions (p < 0.05) in extrinsic tooth stain than did the Crest Regular Fluoride dentifrice, which exhibited a small increase in the extrinsic tooth stain parameters over the course of the study. Additionally, the Colgate Platinum dentifrice provided statistically significantly (p < 0.05) greater removal of extrinsic tooth stain over the course of this six-week study than did the Aquafresh Whitening dentifrice. Thus, the results of the double-blind clinical study support the conclusion that the two tooth whitening dentifrices, Colgate Platinum and Aquafresh Whitening, provide significantly greater (p < 0.05) removal of extrinsic tooth stain than does Crest Regular Fluoride, a sodium fluoride/silica dentifrice. Further, the results of the study support the conclusion that Colgate Platinum dentifrice provides a greater (p < 0.05) level of extrinsic tooth stain removal efficacy than does Aquafresh Whitening dentifrice.

Adult↗

Effects of three different infant dentifrices on biofilms and oral microorganisms.

The purpose of this work was to evaluate the effects of infant dentifrices: A--with lactoperoxidase, glucose oxidase and lactoferrin; B--with 1100 ppm of NaF and sodium lauryl sulfate; C--with extract of calendula. The dentifrices were test on biofilms formed in vitro from saliva and dental plaque of infants, using reference strains A. viscosus (ATCC 43146); C. albicans (ATCC 51501); L. casei (ATCC 4646); S. mitis (ATCC 49456); S. mutans (ATCC 25175); S. oralis (ATCC 35037); S. sanguis (ATCC 10586); S. sobrinus (ATCC 27609) and isolated clinically microorganisms C. albicans, S. mitis, S. mutans, S. oralis, S. sanguis, S. sobrinus and Lactobacillus sp. Twenty infants were chosen, who were beginning treatment at the Infants Clinic of the Pediatric Dentistry Department, Federal University of Rio de Janeiro. A pool of unstimulated saliva and a pool of dental plaque were collected from which biofilms were produced. Supernatants from each dentifrice were prepared and concentrated and diluted solutions of the dentifrices and a control sterile diluent were tested against the biofilms produced, for 1 and 3 minutes, and against the microorganisms. The results were statistically analyzed by the ANOVA and Tukey Test. After the exposure of the biofilms produced both from saliva and from dental plaque, to the dentifrice B concentrated and 1/2, for 1 and 3 minutes, the viable microorganisms count (CFU/ml), compared to the controls, was significantly reduced (p < 0.05). However, exposure to the dentifrices A and C concentrated and dentifrice B 1/4 and 1/8, for 1 and 3 minutes, was not significantly lethal to the biofilms. The dentifrices A and C, either concentrated or diluted (1/2 to 1/128) and the dentifrice B in the dilutions 1/16 to 1/128 did not have an antimicrobial effect on any microorganism evaluated. For all the microorganisms evaluated, the dentifrice B concentrated and in the 1/2 dilution showed a significant antimicrobial effect, when compared with the control (p < 0.05).

Actinomyces viscosus↗

A rapid method for evaluating microbicidal activity of dentifrice formulations against salivary bacteria ex vivo.

A new rapid ex vivo method was developed for evaluating the short-term bactericidal activity of dentifrices against salivary microorganisms. Dentifrice aliquots of 0.25 or 1.0 g were rapidly dispersed into 3.5 mL of freshly pooled human saliva, and 1.0 mL aliquots of the dentifrice-saliva suspension were collected after 30 or 60 seconds of exposure, diluted in neutralizing broth and plated on non-selective agar media for enumeration of surviving total cultivable microflora. Eight experimental dentifrices containing increasing amounts (0 to 2.6%) of a fixed ratio of essential oils (thymol, menthol, methyl salicylate and eucalyptol) were dispersed in saliva at a 0.25:3.5 (w/v) dentifrice:saliva ratio. Recoverable CFUs/mL at 30 sec. were reduced in a dose-responsive manner from > 10(6) to < 10(4). Additional tests using both 0.25 and 1.0 g amounts of dentifrice prototypes containing 2.1% of the essential oil mixture showed that the experimental dentifrices exhibited highly significant (approximately 2.5 log) reductions in viable recoverable microorganisms relative to essential oil-free placebos after both 30- and 60-second exposures. When compared to in vitro models previously used to evaluate the antimicrobial activity of dentifrices, this method provides a rapid, reproducible, more biologically representative means of screening dentifrice formulations for microbicidal activity using dilutions and exposure times approximating those achieved during toothbrushing. However, since other factors may influence microbicidal activity of dentifrice formulations in vivo, conclusions drawn using this model require clinical confirmation.

Analysis of Variance↗

A twelve-week clinical comparison of two tartar control dentifrices.

The objective of this double-blind clinical study, conducted using the Volpe-Manhold evaluation method for dental calculus, was to compare the effect on supragingival calculus formation of a dentifrice containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base (Test Dentifrice), to that of a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base (Positive Control Dentifrice). Adult male and female subjects from the northern New Jersey area were entered into the study based on a pre-test (baseline) Volpe-Manhold Calculus Index score of 7.0 or greater, provided a full oral prophylaxis, and stratified into two treatment groups which were balanced for age, sex and baseline calculus scores. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice, using a soft-bristled toothbrush. Examinations for dental calculus were again performed after twelve weeks' use of the study dentifrices. Seventy-three (73) subjects complied with the protocol, and completed the entire study. At the twelve-week examination, the Test Dentifrice group exhibited a statistically significant 43.5% reduction in mean Volpe-Manhold Calculus Index scores compared to the Positive Control Dentifrice group. The results of this clinical study support the conclusion that a new calculus-inhibiting dentifrice, containing tetrasodium pyrophosphate, sodium tripolyphosphate, and a copolymer in a 0.243% sodium fluoride/silica base, is efficacious for the control of the development of supragingival calculus, and provides a level of benefit greater than that provided by a commercially available calculus-inhibiting dentifrice containing tetrasodium pyrophosphate and a copolymer in a 0.243% sodium fluoride/silica base.

Adult↗

Extrinsic stain removal with a sodium hexametaphosphate-containing dentifrice: comparisons to marketed controls.

Repeated exposure to chlorhexidine and tea has long been recognized to promote extrinsic tooth stain. Previously, the merits of a modified, rapid clinical trial model using chlorhexidine and tea in combination with restricted brushing to accelerate staining have been established. A nine-week randomized and controlled, examiner blind, parallel group clinical trial was conducted to compare selected chemical and mechanical approaches for stain removal using this model. After prophylaxis, stain was induced during a 3-week pre-treatment period, and then the healthy adult volunteers were randomized to one of three treatment groups: an experimental whitening dentifrice containing a combination of sodium hexametaphosphate and soluble pyrophosphate; a marketed alumina-based high abrasive dentifrice; or a lower abrasive control dentifrice. At baseline, three and six weeks, dental stain was measured on the facial and lingual surfaces of the eight anterior teeth using the Lobene index. A total of 94 subjects completed the study. Both the chemical and abrasive dentifrices showed statistically significant reductions in stain area (p < 0.05) relative to the control after three weeks. After six weeks, adjusted mean stain area scores were 0.35, 0.41 and 0.49 for the sodium hexametaphosphate, alumina and regular dentifrice groups, respectively. While the alumina dentifrice showed only a directional benefit, the sodium hexametaphosphate differed statistically (p = 0.023) from the control. Subjects in both the chemical and abrasive dentifrice groups showed statistically significant reductions relative to baseline for Lobene composite stain, stain area and stain intensity (p < 0.05) at six weeks. There were no statistically significant differences in stain levels between the sodium hexametaphosphate and alumina dentifrice groups at any time. This study demonstrates that following six weeks of treatment, sodium hexametaphosphate-containing dentifrices are effective in removing extrinsic tooth stain, with performance at least comparable to that seen with more abrasive dentifrices.

Adult↗

Anticaries and hard tissue abrasion effects of a "dual-action" whitening, sodium hexametaphosphate tartar control dentifrice.

A series of "profile" laboratory studies was conducted to confirm the anticaries potential and hard tissue safety of a novel sodium hexametaphosphate dentifrice technology which provides dual-action tooth whitening (i.e., stain prevention as well as stain removal), while simultaneously providing improved anticalculus action. Under remineralization pH cycling conditions, the dual-action whitening dentifrice produced lesion fluoridation comparable to a conventional NaF dentifrice. Under lesion progression pH cycling conditions, the dual-action whitening dentifrice produced enamel protection against caries initiation and progression comparable to a conventional NaF dentifrice, as well as comparable to a conventional tartar control dentifrice, also containing NaF. These results are consistent with clinical data supporting the anticaries effectiveness of NaF dentifrices combined with anionic tartar control inhibitors, such as pyrophosphate. Abrasion assessments were made using Radioactive Dentin and Enamel Abrasivity (RDA and REA) methods. These laboratory studies demonstrated that the new, dual-action whitening dentifrice produces dentin and enamel abrasivity similar to conventional silica-based dentifrice formulations. These in vitro studies verify the anticaries potential and demonstrate the hard tissue safety of the dual-action, sodium hexametaphosphate dentifrice.

Cariostatic Agents↗

Comparative investigation of the desensitizing efficacy of a new dentifrice: a 14-day clinical study.

The effect on dentinal hypersensitivity from the use of a new formulation dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.) over a 14-day period was compared to a commercially available, nondesensitizing control dentifrice (Colgate Winterfresh Gel, Colgate-Palmolive Co.). A total of 66 subjects were entered into and completed the study. They were stratified into two balanced groups according to their baseline mean tactile (Yeaple Probe) sensitivity scores and air blast (thermal) sensitivity scores. The two groups were randomly assigned to use either the new formulation dentifrice or the commercially available control dentifrice. Participants were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations (tactile and air blast sensitivity) were conducted at baseline and after 3, 7, 10, and 14 days' use of the products. All examinations were conducted by the same examiner. Participants who used the new formulation dentifrice containing potassium nitrate/stannous fluoride/silica demonstrated a statistically significant improvement in both tactile sensitivity and air blast sensitivity after 10 and 14 days' use of the dentifrice (p < 0.05), as compared to a commercially available control dentifrice. It was concluded that a new dentifrice formulation containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base provided a statistically significant reduction in dentinal hypersensitivity after only 10 days, as compared to a commercially available nondesensitizing control dentifrice.

Adult↗

Clinical study to compare extrinsic stain formation in subjects using three dentifrice formulations.

The purpose of this study was to compare the degree of extrinsic dental stain formed with the use of three dentifrices: (1) a new dentifrice formulation containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base (Colgate Sensitive Maximum Strength Toothpaste, Colgate-Palmolive Co.); (2) a commercially available dentifrice containing 5.0% potassium nitrate and 0.243% sodium fluoride in a silica base (Sensodyne Fresh Mint Toothpaste, Block Drug Company, Inc.); and (3) a dentifrice containing 0.243% sodium fluoride in a silica base (Colgate Winterfresh Gel, Colgate-Palmolive Co.). A total of 121 participants were entered into the study and stratified into 3 balanced groups according to baseline mean Lobene Stain Index scores. A thorough dental prophylaxis was completed on each participant after completion of the baseline examination. The three groups were randomly assigned to use one of the three dentifrices. The groups were well balanced with regard to mean baseline stain index scores, gender, and tobacco habits. Participants were instructed to brush their teeth twice daily (morning and evening) for 1 minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Extrinsic dental stain examinations, which measured dental stain area and dental stain intensity, were conducted at baseline and 4 and 8 weeks. Examinations were conducted by the same dental examiner at each examination. After 4 and 8 weeks' use of the test dentifrices, there was no statistically significant difference regarding extrinsic stain formation with the use of any of the dentifrices. Thus, it can be concluded from this study that the use of a new formulation dentifrice containing 5.0% potassium nitrate and 0.454% stannous fluoride in a silica base will not result in a greater formation of extrinsic dental staining than that which is formed by two commercially available dentifrices not known to cause extrinsic dental stain.

Adolescent↗

Tooth-brushing and dentifrice use among children ages 6 to 60 months.

PURPOSE: Tooth-brushing and fluoride dentifrice use are the primary oral health activities for young children. Fluoridated dentifrice has had an important impact on the reduction in children's caries lesion rates, but no studies have focused on patterns of use at multiple time points early in life. The purpose of this paper is to describe tooth-brushing and fluoride dentifrice use in a cohort of children from ages 6 to 60 months. METHODS: The data are from the Iowa Fluoride Study, a longitudinal investigation of fluoride intake from birth. Questionnaires assessed tooth-brushing patterns and fluoride dentifrice use at age 6 months, and at 3-, 4-, or 6-month intervals thereafter. RESULTS: At 6 months of age, 28% of the children's teeth were brushed or cleaned, and 3% of these used fluoridated dentifrice, increasing to 95% at 20 months (83% of them with fluoridated dentifrice). Use of dentifrice flavored for children increased from 40% of those brushing at 9 months to 71% at 60 months. From 9 to 32 months, about 55% of the children were using approximately the recommended amount of dentifrice. However, the percentage using more than recommended increased from 12% at 9 months to 64% at 60 months. Mothers placed the dentifrice on the toothbrush 85% of the time at 9 months, 81% at 20 months, 49% at 36 months, and 31% at 60 months. CONCLUSIONS: By age 2, almost all children were brushing with fluoridated dentifrice, but less than half brushed twice a day, even at age 5. Mothers played the most important role in the children's home care habits.

Adolescent↗

A clinical investigation of the tooth whitening efficacy of a new hydrogen peroxide-containing dentifrice.

OBJECTIVE: The objective of this four-week, double-blind clinical study was to assess the tooth whitening 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 a control dentifrice containing 0.243% sodium fluoride in a silica base (Control Dentifrice). METHODOLOGY: Following a baseline oral soft tissue examination and tooth shade assessment using the Vita Shade Guide, qualifying adult male and female subjects from the New Delhi, India area were randomized into either the Test or Control Dentifrice group. The two groups were balanced for baseline mean Vita Shade Guide rank scores. All subjects were provided with 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 four weeks of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Oral soft tissue and tooth shade evaluations for each subject were repeated after two and four weeks of product use. RESULTS: Forty-four (44) subjects complied with the protocol and completed the entire study. At the two- and four-week examinations, the Test Dentifrice group had statistically significant mean shade rank score reductions of 4.04 and 5.17, respectively, compared to baseline (p < 0.05), while the Control Dentifrice had respective reductions of 0.41 and 0.53, which were also statistically significant. The mean shade rank reductions in the Test group compared to those in the Control group at two and four weeks were 3.63 and 4.64, respectively, and were statistically significant (p < 0.05). CONCLUSION: A new whitening dentifrice delivering 1.0% hydrogen peroxide, 0.243% sodium fluoride and sodium tripolyphosphate has significant tooth whitening effectiveness, producing a mean shade rank score reduction from baseline of 5.17 after four weeks' use.

Adolescent↗

Brushing with a potassium nitrate dentifrice to reduce bleaching sensitivity.

OBJECTIVE: This research systematically evaluated the use of a clinically proven desensitizing dentifrice prior to a bleaching regimen in a randomized, multi-center, parallel group, open label clinical study following Good Clinical Practice guidelines. METHODOLOGY: Fourteen dental offices in West Palm Beach, Florida participated in the study during April/May 2004. Fourteen days prior to bleaching, impressions and oral soft tissue assessments were performed, and patients were randomized to either a KNO3 plus fluoride dentifrice (Sensodyne Fresh Mint), or a standard fluoride dentifrice (Crest Regular), brushing 2x per day. On Day 14, patients returned to the dental office for their custom tray and the dispensation of a bleaching kit (Day White Excel 3; 9.5% hydrogen peroxide and KNO3). This was used daily according to the manufacturer's instructions for 30 minutes, and normal oral hygiene continued to be performed using the assigned toothbrush and dentifrice, brushing 2x per day. At the end of each bleaching day, patients answered diary questions about the occurrence and intensity of sensitivity. At the conclusion of the 14-day bleaching period (Day 28), patients returned to their dental office for re-examination, returning all products and diaries. Within seven days of completing the study, patients answered a telephone patient satisfaction survey. RESULTS: A total of 202 patients in fourteen (14) dental offices completed all aspects of the study and were used for the analysis. The professionally dispensed bleaching product provided an improvement of approximately 4.4 Vita shades, regardless of whether it was used with the KNO3 plus fluoride (Sensodyne) or a standard fluoride (Crest) dentifrice. The patient perception of increased sensitivity caused by the bleaching treatment was low but measurable. In the first week of the bleaching, significantly more patients using the KNO3 plus fluoride dentifrice were free from sensitivity (58%) than the standard fluoride dentifrice group (42%). During the 14-day bleaching treatment period, the KNO3 dentifrice patients experienced significantly more "sensitivity free days" (average = 10.1) compared to the standard fluoride dentifrice group (average = 8.6). CONCLUSION: The use of the KNO3 plus fluoride dentifrice (Sensodyne), two weeks prior to and throughout bleaching, may be a useful adjunct for the management of sensitivity caused by professionally dispensed bleaching products. With the bleaching-induced tooth sensitivity, those patients in the KNO3 plus fluoride toothpaste group were significantly more satisfied with their whitening experience and willing to repeat the bleaching treatment.

Adult↗

The effect of an anticalculus dentifrice on supragingival calculus formation and gingival recession in Thai adults: a one-year study.

A one-year, double-blind clinical study was conducted on a population of male and female adults to determine the effect of the twice daily use of an anticalculus dentifrice on supragingival calculus formation and gingival recession, as compared to the use of a placebo dentifrice. The subjects were initially evaluated for calculus using the Volpe-Manhold scoring procedure and for gingival recession using the Gingival Recession Total (GRT) scoring procedure of Volpe, Triratana and Rustogi. All subjects received an oral prophylaxis and were assigned to the use of either a placebo dentifrice containing 0.243% sodium fluoride in a silica base or an anticalculus dentifrice containing 1.3% soluble pyrophosphate and 1.5% Gantrez copolymer in a 0.243% sodium fluoride/silica base. After six months, the subjects using the anticalculus dentifrice had 24.14% significantly less supragingival calculus than the placebo dentifrice subjects. After one year, the subjects using the anticalculus dentifrice had 40.76% significantly less supragingival calculus than the placebo dentifrice subjects. Also, after one year, the subjects using the anticalculus dentifrice had 27.75% significantly less gingival recession than the placebo dentifrice subjects.

Adult↗

Effect of a dentifrice containing triclosan and a copolymer on plaque formation and gingivitis.

A total of one hundred twenty-one (121) adult male and female subjects completed a 6-month, double-blind clinical study comparing the effect on supragingival plaque formation and gingivitis of a dentifrice containing 0.3% Triclosan and 2.0% of a copolymer of methoxyethylene and maleic acid to a placebo dentifrice. Both the Triclosan/copolymer and placebo dentifrices contained 0.243% sodium fluoride in a silica base. Subjects were stratified into two balanced groups according to baseline plaque and gingivitis scores. They then received an oral prophylaxis and were assigned to use either the Triclosan/copolymer dentrifrice or the placebo dentifrice for the next 6 months. Subjects were evaluated for supragingival plaque formation and gingivitis after 3 and 6 months' use of the dentifrices. After 6 months, the Triclosan/copolymer dentifrice was shown to provide a 32.32% statistically significant reduction (99% level of confidence) in supragingival plaque formation, as compared to the placebo dentifrice. Also, after 6 months, the Triclosan/copolymer dentifrice was shown to provide a 25.64% statistically significant reduction (99% level of confidence) in gingivitis, as compared to the placebo dentifrice. It thus can be concluded from this clinical study that the twice daily use of the dentifrice containing 0.3% Triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride/silica base provides statistically significant reductions in both supragingival plaque formation and gingivitis.

Adult↗

Clinical efficacy of an anticalculus fluoride dentifrice containing triclosan and a copolymer: a 6-month study.

A 6-month, double-blind, parallel and unsupervised clinical study was conducted to compare the effects on supragingival calculus formation of a dentifrice containing 0.3% triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride/silica base, as compared to a placebo dentifrice containing 0.243% sodium fluoride in a silica base. Subjects were initially stratified into two balanced groups based on their Volpe-Manhold calculus index scores that were obtained from a 3-month pre-test period using a placebo dentifrice. All subjects received an oral prophylaxis and were assigned to the use of either the fluoride/triclosan/copolymer dentifrice or the placebo dentifrice. Seventy adult male and female subjects completed the entire 6-month study. The results after 3-months' use of their respective dentifrices indicated that the subjects using the fluoride/triclosan/copolymer dentifrice had 26.34% less supragingival calculus formation than the subjects using the placebo dentifrice. This reduction in supragingival calculus was significant at the 99% level of confidence. The results after 6 months indicated that the subjects using the fluoride/triclosan/copolymer dentifrice had 36.27% less supragingival calculus formation than the subjects using the placebo dentifrice. This reduction was significant at the 99% level of confidence.

Adult↗

Effects of two fluoride dentifrices containing triclosan and a copolymer on calculus formation.

A 12-week, double-blind, parallel and unsupervised clinical study was conducted to compare the effects on supragingival calculus formation of two dentifrices containing triclosan (Irgacare MP) and a copolymer of methoxyethylene and maleic acid (Gantrez) as compared to a placebo dentifrice. All 147 adult male and female subjects completed the study. Subjects were stratified into three balanced groups on the basis of their Volpe-Manhold index calculus scores as obtained from a 3-month pre-test period using a placebo dentifrice. After a complete oral prophylaxis, subjects were assigned to the use of either the placebo dentifrice, a dentifrice containing 0.3% triclosan and 2.0% of a copolymer in a 0.243% sodium fluoride silica base, or a dentifrice containing 0.3% triclosan and 2.0% of a coplymer in a 0.76% sodium monofluorophosphate alumina base. Subjects, after brushing with their assigned dentifrice and soft-bristled toothbrush for 12 weeks, were evaluated by the examining dentist for supragingival calculus formation using the Volpe-Manhold assessment method. These examinations showed that the dentifrice containing 0.3% triclosan/2.0% copolymer in a 0.243% sodium fluoride silica base reduced supragingival calculus deposits by 23.12% and the dentifrice containing 0.3% triclosan/2.0% copolymer in a 0.76% sodium monofluorophosphate alumina base reduced supragingival calculus deposits by 26.15%. Both of these reductions in supragingival calculus were compared to the placebo dentifrice and were statistically significant at the 99% level of confidence.

Adult↗

Efficacy of a dentifrice containing potassium nitrate, soluble pyrophosphate, PVM/MA copolymer, and sodium fluoride on dentinal hypersensitivity: a twelve-week clinical study.

The effect on dentinal hypersensitivity from the use of a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer, and 0.243% sodium fluoride in a silica base over a twelve-week period was compared to a matching placebo dentifrice without potassium nitrate. A total of sixty-seven subjects were entered into the study, and stratified into two balanced groups according to their baseline mean thermal (threshold) temperature (Thermodontic Stimulator) and baseline mean tactile (Yeaple Probe) sensitivity scores. The two groups were randomly assigned to use either the potassium nitrate/copolymer/pyrophosphate dentifrice or the placebo dentifrice. The two groups were well balanced with regard to their mean baseline thermal and tactile sensitivity scores, sex and age. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations, which included tactile sensitivity, threshold thermal sensitivity, pain thermal sensitivity, air blast, and a visual analog scale were conducted at baseline, six weeks, and twelve weeks. All examinations were conducted by the same dental examiner. After six weeks' use of their assigned products, those subjects in the potassium nitrate/copolymer/pyrophosphate dentifrice group demonstrated statistically significant improvements (p < 0.01), as compared to the placebo dentifrice, in the following parameters: 1) tactile; 2) thermal (threshold and pain); and 3) air blast. After twelve weeks' use of their assigned products, those subjects in the potassium nitrate/copolymer/pyrophosphate dentifrice group again demonstrated statistically significant improvements (p < 0.01), in tactile, thermal (threshold and pain) and air blast sensitivity, as compared to the placebo dentifrice. It was concluded from this study that a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer, and 0.243% sodium fluoride in a silica base is a clinically effective treatment for reducing dentinal hypersensitivity.

Adult↗

Comparative efficacy of two dentifrices containing 5% potassium nitrate on dentinal sensitivity: a twelve-week clinical study.

The effect of a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer, and 0.243% sodium fluoride in a silica base (Sensitive/Tartar Control) on dentinal hypersensitivity over a twelve-week period was compared to a commercially available dentifrice containing 5% potassium nitrate and 0.76% sodium monofluorophosphate in a dicalcium phosphate dihydrate base (Sensodyne-F). A total of ninety-seven subjects were entered into the study, and stratified into two balanced groups according to their baseline mean air sensitivity score and baseline mean tactile (Yeaple Probe) sensitivity score. The two groups were randomly assigned to use either the Sensitive/Tartar Control dentifrice or the commercially available hypersensitivity control dentifrice with potassium nitrate. The two groups were balanced with regard to their mean baseline air and tactile sensitivity scores, sex and age. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a commercially available soft-bristled toothbrush. Dentinal hypersensitivity examinations, which included tactile sensitivity, cold air blast, and a visual analog scale were conducted at baseline, six weeks, and twelve weeks. All examinations were conducted by the same dental examiner. After six weeks' use of the assigned dentifrices, there were no statistically significant differences between dentifrice groups in any of the parameters assessed (tactile, cold air blast and visual analog scale). After twelve weeks' use of the assigned products, there were no statistically significant differences between dentifrice groups in any of the parameters assessed (tactile, cold air blast and visual analog scale). Thus it can be concluded from this study that the use of a dentifrice containing 5.0% potassium nitrate, 1.3% soluble pyrophosphate, 1.5% PVM/MA copolymer, and 0.243% sodium fluoride in a silica base provides a clinically effective method of reducing dentinal hypersensitivity which is comparable in efficacy to a commercially available hypersensitivity control dentifrice containing 5% potassium nitrate and 0.76% sodium monofluorophosphate in a dicalcium phosphate dihydrate base.

Adult↗