Effect of stannous fluoride and zinc phosphate dentifrice on dental plaque and gingivitis: A randomized clinical trial with 6-month follow-up.

OBJECTIVE: The objective of this study was to compare a stabilized stannous fluoride (SnF2) dentifrice with zinc phosphate (Colgate TotalSF) with SnF2 with zinc lactate and control fluoride dentifrices for gingivitis and plaque control over a 6-month period. METHODS: A total of 135 adult participants were enrolled in this study. After randomization and blinding of examiners and patients, enrolled participants were provided instructions for use of assigned dentifrice. At 3 visits (0, 3, and 6 months), various gingival and plaque indexes were collected to determine the clinical efficacy of a stabilized SnF2 dentifrice. These results were compared with a SnF2 with zinc lactate dentifrice and with a control fluoride dentifrice. RESULTS: A total of 135 participants completed the study. All groups reported statistically significant reductions in gingival inflammation and improvement in plaque control at 3- and 6-month follow-up. Both SnF2 dentifrices showed statistically significant reductions in all indexes compared with the control dentifrice (P < .001). However, the test dentifrice showed higher but nonsignificant improvements in plaque and gingival indexes compared with the other SnF2 dentifrice. CONCLUSIONS: This study reports similar efficacy of a test dentifrice to a commercial SnF2-containing dentifrice for plaque control and reduction in gingival inflammation and provides supporting evidence that the test dentifrice maintains its clinical efficacy with change of formulation. PRACTICAL IMPLICATIONS: This newly formulated SnF2 stabilized with zinc phosphate dentifrice may be of benefit to patients in controlling plaque biofilm and gingivitis.

A Clinical Investigation of a Dual Zinc plus Arginine Dentifrice in Reducing Established Dental Plaque and Gingivitis Over a Six-Month Period of Product Use.

OBJECTIVES: The objective of this single-center, double-blind, parallel-group, randomized six-month clinical study was to evaluate the clinical efficacy of a new Dual Zinc plus Arginine dentifrice (Colgate-Palmolive Co., New York, NY, USA) containing zinc (zinc oxide, zinc citrate) 0.96%, 1.5% Arginine, and 1450 ppm fluoride as sodium fluoride in a silica base in reducing established dental plaque and gingivitis over a six-month period, relative to that of a regular fluoride dentifrice containing 1450 ppm fluoride as sodium fluoride in a silica base (Colgate- Palmolive Co., New York, NY, USA). METHODS: A total of 100 adult male and female subjects from Santo Domingo, Dominican Republic were enrolled in this clinical study. During the baseline visit, the dental examiner clinically measured three gingival parameters (gingival index, gingival severity index, gingival interproximal index) and three plaque parameters (plaque index, plaque severity index, plaque interproximal index). The examining clinician also performed an assessment of the oral soft and hard tissues. All subjects were then assigned a subject identification number in chronological order from 001 to 100 and were randomly assigned to one of two treatment groups following a computer-generated randomization list. They were provided with their assigned dentifrice and an adult, soft-bristled toothbrush for home use, and were instructed to brush twice daily (morning and evening) for one minute with the assigned dentifrice for a period of six months. Subjects returned to the study facility site for their follow-up evaluation of plaque and gingivitis parameters after three and six months. RESULTS: Ninety-six (96) subjects completed the study. At the three-month evaluation, subjects in the Dual Zinc plus Arginine dentifrice group exhibited statistically significant (p < 0.001) reductions in all gingival and plaque parameters relative to subjects in the fluoride dentifrice group. For gingival parameters, reductions were 18.8% for gingival index, 33.3% for gingival severity index, and 19.1% for gingival interproximal index. For plaque parameters, reductions were 11.0% for plaque index, 22.4% for plaque severity index, and 9.8% for plaque interproximal index. At the six-month evaluation, subjects in the Dual Zinc plus Arginine dentifrice group presented continuous statistically significant (p < 0.001) reductions in all three gingival and plaque parameters when compared to the subjects in the fluoride dentifrice group. For gingival parameters, reductions were 26.3% for gingival index, 56.6% for gingival severity index, and 29.2% for gingival interproximal index. For plaque parameters, reductions were 30.1% for plaque index, 61.9% for plaque severity index, and 28.0% for plaque interproximal index after six months of product use. CONCLUSIONS: The overall results of this double-blind clinical study support the conclusion that a Dual Zinc plus Arginine dentifrice containing zinc (zinc oxide, zinc citrate) 0.96%, 1.5% Arginine, and 1450 ppm fluoride as sodium fluoride in a silica base provides significantly greater reduction in dental plaque and gingivitis parameters as compared to a regular fluoride dentifrice containing 1450 ppm fluoride as sodium fluoride in a silica base after three months and six months of product use.

A Clinical Investigation of the Efficacy of a Dual Zinc plus Arginine Dentifrice for Controlling Oral Malodor.

OBJECTIVES: The objective of this independent, double-blind clinical study was to assess the efficacy of a new Dual Zinc plus Arginine dentifrice (Colgate-Palmolive Co., New York, NY, USA) containing zinc (zinc oxide, zinc citrate) 0.96%, 1.5% arginine, and 1450 ppm F as sodium fluoride in a silica base for the 12-hour overnight oral malodor reduction after three weeks of product use, relative to that of a regular fluoride dentifrice containing 1450 ppm F as sodium fluoride in a silica base (Colgate-Palmolive Co., New York, NY, USA). METHODS: A total of eighty (80) adult male and female subjects from Chengdu, People's Republic of China, were enrolled in this clinical study. Following an assessment of the oral soft and hard tissues, subjects were evaluated for baseline oral malodor by a panel of four trained and calibrated judges using a nine-point organoleptic hedonic scale. They were then randomly assigned to one of two treatment groups (Dual Zinc plus Arginine - test; regular fluoride dentifrice - control). Subjects were provided with their assigned dentifrice and toothbrush and instructed to brush their teeth twice daily (morning and evening) for one minute. After three weeks, subjects returned to the study site for their follow-up evaluation of malodor after having refrained from brushing for 12 hours (overnight). RESULTS: Eighty (80) subjects completed the study. After three weeks of product use, subjects in the Dual Zinc plus Arginine dentifrice group and the regular fluoride dentifrice group showed statistically significant (p < 0.001) reductions of 38.9% and 11.6%, respectively, in organoleptic scores as compared to baseline. Relative to the regular fluoride dentifrice group, subjects in the Dual Zinc plus Arginine dentifrice group exhibited a statistically significant (p< 0.001) reduction of 30.8% in oral malodor. The quality of breath for subjects in the Dual Zinc plus Arginine dentifrice group was in the range corresponding to pleasant breath, whereas the quality of breath for subjects in the regular fluoride dentifrice group was in the range corresponding to unpleasant breath. CONCLUSIONS: The overall results of this double-blind clinical study support the conclusion that a new Dual Zinc plus Arginine dentifrice containing zinc (zinc oxide, zinc citrate) 0.96%, 1.5% arginine, and 1450 ppm fluoride as sodium fluoride in a silica base provides a significantly greater reduction in oral malodor as compared to a regular fluoride dentifrice containing 1450 ppm fluoride as sodium fluoride in a silica base 12 hours post-brushing (overnight) after 3 weeks of product use.

Comparative efficacy of two treatment regimens combining in-office and at-home programs for dentin hypersensitivity relief: a 24-week clinical study.

PURPOSE: Dentin hypersensitivity is a significant clinical problem that affects numerous individuals. This sharp pain, arising from exposed dentin in response to external stimuli, can be a particularly uncomfortable and unpleasant sensation for patients, because it interferes with their quality of life. The objective of this 24-week, single-center, parallel group, double-blind, stratified and randomized clinical study was to evaluate the clinical efficacy of a single professional treatment with an in-office desensitizing paste followed by twice daily brushing with a desensitizing toothpaste and toothbrush for 24 weeks. METHODS: 100 adults with confirmed dentin hypersensitivity were randomly assigned into two groups. One group received a single in-office treatment with a desensitizing paste containing 8% arginine and calcium carbonate (marketed as Colgate Sensitive Pro-Relief Desensitizing Paste and Elmex Sensitive Professional desensitizing paste), after dental scaling, followed by 24 weeks of brushing twice daily with a desensitizing toothpaste containing 8% arginine, calcium carbonate with 1450 ppm fluoride as MFP (marketed as Colgate Sensitive Pro-Relief toothpaste and Elmex Sensitive Professional toothpaste) and using the Colgate Sensitive Pro-Relief toothbrush (Test Group). The other group received a single in-office treatment with Nupro-M pumice prophylaxis paste, after dental scaling, followed by 24 weeks of brushing twice daily with a non-desensitizing toothpaste containing 1450 ppm fluoride as MFP and with the Oral-B Indicator toothbrush (Negative Control Group). Hypersensitivity was reexamined immediately after in-office product application and after 8 and 24 weeks of twice daily brushing. RESULTS: Immediately after professional product application, and after 8 and 24 weeks, subjects assigned to the Test Group demonstrated statistically significant improvements in dentin hypersensitivity compared to subjects assigned to the Negative Control Group in tactile (49.8%, 57.5% and 32.9%, respectively) and air blast (26.0%, 38.4% and 34.3%, respectively) sensitivity scores. The instant reductions in dentin hypersensitivity provided by the single professional application of a desensitizing paste for in-office use, containing 8% arginine and calcium carbonate were maintained by twice daily brushing with the 8% arginine, calcium carbonate toothpaste with 1450 ppm fluoride as MFP and the Colgate Sensitive Pro-Relief toothbrush for at least 24 weeks.

Comparison of clinical efficacy of three toothpastes in reducing dentin hypersensitivity.

OBJECTIVE: The objective of the study was to compare the clinical efficacy in reducing dentin hypersensitivity of a test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as sodium fluoride (NaF) in a silica base, to a positive control toothpaste containing 8.0% arginine and 1450 ppm fluoride as sodium monofluorophosphate (MFP) in a calcium carbonate base, and a negative control toothpaste containing 1100 ppm fluoride as NaF in a silica base. METHODS: Subjects identified with two hypersensitive teeth using the tactile (Yeaple Probe) and air blast (Schiff's Scale) hypersensitivity methods were assigned to their treatment group. There were 50 subjects per group. Subjects then self-applied the assigned toothpaste to their hypersensitive teeth using a fingertip, then brushed their teeth at home using the same toothpaste twice daily for seven days. Dentin hypersensitivity and oral tissues were evaluated at baseline, immediately after the single application, and after seven days. A chi-square analysis was conducted to examine the effects with respect to gender between treatments. Comparisons of the age and baseline hypersensitivity data among groups were performed using the analysis of variance (ANOVA). Within-treatment effects were analyzed using the paired t-test, while the analysis of covariance (ANCOVA) was used to determine the between-treatment effects. The post hoc Tukey's test was performed for the pair-wise comparisons using a significance level of alpha = 0.05. RESULTS: All 150 subjects complied with the protocol and completed the study. The positive control toothpaste containing 8.0% arginine and 1450 ppm fluoride as MFP in a calcium carbonate base provided statistically significant improvements in mean tactile and air blast dentin hypersensitivity scores compared to the negative control toothpaste containing 1100 ppm fluoride as NaF in a silica base (p < 0.05). The toothpaste containing 8.0% arginine and 1450 ppm fluoride as MFP in a calcium carbonate base (positive control) also provided statistically significant improvements in mean tactile and air blast dentin hypersensitivity scores compared to the test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as NaF in a silica base. The test toothpaste and the negative control toothpaste were not significantly different from each other. CONCLUSION: The test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as NaF in a silica base, when used for a single topical application and twice-daily brushing for seven days, does not provide statistically significant relief of dentin hypersensitivity compared to a negative control toothpaste containing 1100 ppm fluoride as NaF in a silica base. In contrast, the positive control toothpaste containing 8.0% arginine and 1450 ppm fluoride as MFP in a calcium carbonate base provided significantly reduced dentin hypersensitivity compared to the negative control toothpaste, and was significantly more effective than the test toothpaste containing 8% strontium acetate and 1040 ppm fluoride as NaF in a silica base.

Extrinsic stain removal efficacy of a new dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% NaF and specially-designed silica for sensitivity relief and whitening benefits as compared to a dentifrice containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF and to a negative control dentifrice containing 0.243% NaF: a 6-week study.

PURPOSE: This single-center, double-blind, randomized, parallel-group clinical study was designed to investigate the extrinsic stain removal efficacy of a new antisensitivity dentifrice containing 0.3% triclosan, 2% polyvinylmethyl ether/maleic acid copolymer (PVM/MA copolymer), 0.243% NaF and a new silica specially-designed to occlude dentin tubules, relative to a Positive Control dentifrice and a Negative Control dentifrice. METHODS: 117 qualifying adults were stratified by baseline Lobene Stain Index scores and randomly assigned to brush twice daily using a soft-bristled toothbrush and one of three dentifrices: (1) the Test Dentifrice; (2) a previously clinically proven dentifrice variant containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF in a high cleaning silica base (Positive Control); and (3) a dentifrice containing 0.243% NaF in a silica base (Negative Control). Extrinsic stain area and stain intensity examinations were repeated after 3 and 6 weeks of product use. RESULTS: Relative to the Negative Control group, the Test group and the Positive Control group exhibited statistically significant improvements in mean Lobene composite stain scores after 3 weeks of product use (39.8% and 40.7% respectively) and after 6 weeks of product use (58.8% and 61.8% respectively). There were no statistically significant differences observed between the stain removal performance of the Test Dentifrice and the Positive Control Dentifrice after 3 and 6 weeks of product use.

Extrinsic stain removal efficacy of a new desensitizing dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride.

PURPOSE: To evaluate the extrinsic stain removal efficacy of a new Pro-Argin formula whitening dentifrice containing 8.0% arginine, a high cleaning calcium carbonate and 1450 ppm fluoride, as monofluorophosphate, after brushing twice daily for 4 and 8 weeks. METHODS: At the baseline visit, 92 adult subjects were stratified based on their Lobene Stain Index scores and randomized into two treatment groups; one using the new Pro-Argin formula whitening dentifrice (test group) and the other using the original Pro-Argin formula dentifrice (control group). Subjects were instructed to brush twice daily for the duration of the study. Tooth stain evaluations were conducted as stain area and stain intensity according to the Lobene Stain Index. RESULTS: All 92 enrolled subjects complied with the protocol and completed the 8-week study. Baseline scores demonstrated no significant differences between the two treatment groups for the evaluated area and intensity parameters of stain (P > 0.05). At both the 4- and 8-week post-use evaluations, subjects brushing with the test dentifrice demonstrated significant reductions for all stain parameters versus the control (P < 0.05). Relative to the control group, the test group demonstrated reductions in mean stain intensity scores of 9.7% and 17.9% at the 4- and 8-week evaluations, respectively. Corresponding reductions in mean stain area scores for the test group relative to the control were 11.7% and 20.8% at the 4- and 8-week evaluations, respectively. (Am JDent 2010;23 Sp Is A:36A-40A).

Clinical evaluation of the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate in providing instant and lasting relief of dentin hypersensitivity.

PURPOSE: To determine the efficacy of an in-office desensitizing paste containing 8% arginine and calcium carbonate relative to that of a commercially-available pumice prophylaxis paste in reducing dentin hypersensitivity instantly after a single application following a dental scaling procedure and to establish the duration of sensitivity relief over a period of 4 weeks and 12 weeks. METHODS: This was a single-center, parallel group, double-blind, stratified clinical study conducted in San Francisco, California, USA. Qualifying adult male and female subjects who presented two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10-50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were stratified according to their baseline hypersensitivity scores and randomly assigned within strata to one of two treatment groups: (1) A Test Paste, a desensitizing paste containing 8% arginine and calcium carbonate (Colgate-Palmolive Co); and (2) A Control Paste, Nupro pumice prophylaxis paste (Dentsply Professional). Subjects received a professionally-administered scaling procedure, after which they were re-examined for tactile and air blast dentin hypersensitivity (Post-Scaling Examinations). The assigned pastes were then applied as the final step to the professional dental cleaning procedure. Tactile and air blast dentin hypersensitivity examinations were again performed immediately after paste application. Subjects were provided with a commercially-available non-desensitizing dentifrice containing 0.243% sodium fluoride (Crest Cavity Protection, Procter & Gamble Co.) and an adult soft-bristled toothbrush and were instructed to brush their teeth for 1 minute, twice daily at home using only the toothbrush and dentifrice provided, for the next 12 weeks. Subjects returned to the testing facility 4 and 12 weeks after the single application of Test or Control paste, having refrained from all oral hygiene procedures and chewing gum for 8 hours and from eating and drinking for 4 hours, prior to each follow-up visit. Assessments of tactile and air blast hypersensitivity, and examinations of oral soft and hard tissue were repeated at these 4- and 12-week examinations. RESULTS: 68 subjects completed the 12-week study. No statistically significant differences from baseline scores were indicated at the Post-Scaling Examinations for either the Test Paste or Control Paste groups. Immediately following product application and 4 weeks after product application, subjects assigned to the Test Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (44.1% and 45.9% respectively) and mean tactile hypersensitivity scores (156.2% and 170.3% respectively). At the same time points, subjects assigned to the Control Paste group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean air blast (15.1% and 8.9% respectively) and mean tactile hypersensitivity scores (43.1% and 8.3% respectively). Immediately following application of the assigned paste and 4 weeks later, the Test Paste group demonstrated statistically significant reductions in dentin hypersensitivity with respect to baseline-adjusted mean air blast (34.1% and 40.6% respectively) and mean tactile hypersensitivity scores (79.0% and 149.6% respectively), compared to the Control Paste group. No statistically significant differences were exhibited between paste groups at the Post-Scaling and 12-week examinations with respect to mean tactile and baseline-adjusted mean air blast hypersensitivity scores.

Clinical evaluation of the efficacy of a desensitizing paste containing 8% arginine and calcium carbonate for the in-office relief of dentin hypersensitivity associated with dental prophylaxis.

PURPOSE: To evaluate the clinical efficacy in reducing dentin hypersensitivity of a professional desensitizing paste containing 8% arginine and calcium carbonate relative to that of a commercially-available pumice prophylaxis paste when applied pre-procedurally to a professional dental cleaning (dental prophylaxis). METHODS: This was a single-center, parallel group, double-blind, stratified clinical study, conducted in Langhorne, Pennsylvania. Adult male and female subjects who presented a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force and an air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale) were stratified according to their baseline hypersensitivity scores and randomly assigned within strata to one of two treatment groups. The two treatment groups were: (1) a Test paste, a desensitizing paste containing 8% arginine and calcium carbonate (Colgate-Palmolive Co.); and (2) a Control paste, Nupro pumice prophylaxis paste (Dentsply Professional). Subjects had their assigned paste applied immediately before receiving a professional dental cleaning procedure. After the completion of the dental cleaning procedure, tactile and air blast dentin hypersensitivity examinations were again performed following the same methodology employed for the baseline hypersensitivity examinations. RESULTS: 45 subjects completed the study. At the final hypersensitivity examinations, conducted immediately after the completion of the dental cleaning procedure, subjects assigned to the test group exhibited statistically significant improvements from baseline with respect to baseline-adjusted mean tactile (132.1%) and air blast hypersensitivity scores (48.6%). Additionally, subjects assigned to the control group exhibited a statistically significant hypersensitivity improvement from baseline with respect to baseline-adjusted mean air blast hypersensitivity scores (13.9%). The hypersensitivity improvement from baseline indicated for the control group for mean tactile hypersensitivity scores (21.7%) was not statistically significant. At the final hypersensitivity examinations, statistically significant differences were indicated between the test group and the control group with respect to baseline-adjusted mean tactile (110.0%) and air blast hypersensitivity scores (41.9%).

A clinical investigation of the efficacy of two dentifrices for the reduction of supragingival calculus formation.

OBJECTIVE: The objective of this double-blind clinical study, conducted in harmony with Volpe-Manhold design for studies of dental calculus, was to compare the efficacy of a dentifrice containing 0.3% triclosan/2.0% polyvinylmethyl ether/maleic acid (PVM/MA) copolymer/0.243% sodium fluoride in a 17% dual silica base (Colgate Total Advanced Toothpaste) to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base (Crest Cavity Protection Toothpaste) with respect to the reduction of supragingival calculus formation. METHODS: Adult male and female subjects from the San Francisco area were entered into the eight-week pre-test phase of the study. Subjects received an evaluation of oral soft and hard tissues and were given a complete oral prophylaxis. They were provided with a non-tartar control placebo dentifrice and a soft-bristled adult toothbrush, and were instructed to brush their teeth twice daily (morning and evening) for one minute. After eight weeks of using the placebo dentifrice, subjects were examined for baseline supragingival calculus formation using the Volpe-Manhold Calculus Index. Qualifying subjects were randomized into two treatment groups which were balanced for gender and baseline calculus scores. All subjects entered into the twelve-week test phase were given a complete oral prophylaxis, and were provided with their assigned dentifrice and a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for one minute twice daily (in the morning and evening). Prior to each study visit, subjects refrained from brushing their teeth and eating and drinking for four hours. RESULTS: Seventy-seven (77) subjects complied with the protocol and completed the study. At the twelve-week examination, the Test Dentifrice group presented a mean Volpe-Manhold Calculus Index score of 13.22 and the Control Dentifrice group presented a score of 20.29. After twelve weeks of product use, the Test Dentifrice group exhibited 34.8% less supragingival calculus formation than the Control Dentifrice group (statistically significant at p < 0.05). CONCLUSION: The overall results of this double-blind clinical study support the conclusion that after twelve weeks' use of a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride in a 17% dual silica base provides significantly greater control of supragingival calculus formation relative to that of a commercially available dentifrice containing 0.243% sodium fluoride in a silica base.

Tooth-whitening efficacy of custom tray-delivered 9% hydrogen peroxide and 20% carbamide peroxide during daytime use: a 14-day clinical trial.

OBJECTIVE: The purpose of this 14-day parallel, double blind clinical trial was to evaluate the tooth whitening efficacy of a 9% hydrogen peroxide gel (Colgate Visible White) relative to a 20% carbamide peroxide gel (Opalescence) positive control. METHODS: Forty-six consenting adults were randomly assigned to use one of the two products. All participants had 6 unrestored maxillary anterior teeth averaging a shade ranking score of 9 (A3) in the Vitapan Classical Shade Guide scale of 1 through 16 (lightest to darkest). Tooth whitening consisted of at-home 30-minute daily self-applications of the assigned product after brushing with a non-bleaching dentifrice. One of two calibrated examiners performed the baseline, 5-day, 7-day, and 14-day tooth shade evaluations for a given participant, utilizing the same Vita guide under unmodified color-corrected lighting conditions. Thirty-seven participants made all visits. Bleaching efficacy was measured with respect to mean shift (reduction from baseline) in rank scores of the maxillary anterior teeth, in which baseline rank scores functioned as covariables. RESULTS: Both treatment groups exhibited statistically significant mean shade rank score improvements from baseline after 5, 7, and 14 days at 3.14, 3.70 and 4.68 for Colgate Visible White and 1.60, 2.52 and 3.85 for Opalescence. CONCLUSIONS: Between-group comparison shows that while Colgate Visible White (9% hydrogen peroxide) provides a statistically significant tooth whitening improvement over Opalescence (20% carbamide peroxide) after 5 days of self-application, both products have a similar whitening effect after 7 and 14 days.