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.

Evaluation of a stabilized stannous fluoride dentifrice on dental plaque and gingivitis in a randomized controlled trial with 6-month follow-up.

BACKGROUND: The objective of this study was to compare a stannous fluoride (SnF2) dentifrice (Colgate TotalSF) stabilized with zinc phosphate with a sodium fluoride control dentifrice for gingivitis and plaque control over a 6-month period. METHODS: One hundred adult participants were enrolled in this study conducted in Chengdu, China. After random assignment and blinding of examiners and patients, enrolled participants received instructions for use of the assigned dentifrice. At 3 visits (baseline and 3 and 6 months), the authors measured various gingival and plaque indexes to determine the clinical efficacy of the stabilized SnF2 dentifrice compared with those of the control fluoride dentifrice (2 groups). RESULTS: Ninety-eight participants completed the study. Both groups (test and control) had statistically significant reductions in gingival inflammation and improvement in plaque control at the 3- and 6-month follow-ups. In addition, the test dentifrice showed statistically significant reductions in all indexes compared with the control dentifrice (P < .001). CONCLUSIONS: This study's results show statistically significantly improved clinical outcomes for reduction of gingival inflammation and improvement in biofilm control over a 6-month period through the use of a SnF2 dentifrice stabilized with zinc phosphate when compared with results with a fluoride control dentifrice. PRACTICAL IMPLICATIONS: This newly formulated dentifrice improves gingival health and plaque control and thereby may aid patients in attaining improved oral health.

Solving the problem with stannous fluoride: Extrinsic stain.

BACKGROUND: This article highlights a stabilized stannous fluoride (SnF2) dentifrice that, in addition to being efficacious against caries, gingivitis, and dentin hypersensitivity, demonstrates high-performing stain prevention and removal efficacy. METHODS: An in vitro stain prevention model evaluated the efficacy of Colgate TotalSF containing 0.454% SnF2 and 1% zinc phosphate compared with Crest Pro-Health Whitening Power (The Procter & Gamble Company) and a nonabrasive SnF2 gel. L*, a*, and b* values were measured to assess whiteness comparing untreated and stained teeth, and with statistical analysis. A stain removal clinical study was conducted as a randomized, double-blind, 2-cell, parallel-group design using Colgate TotalSF and nonwhitening regular fluoride toothpaste. Participants were instructed to brush twice daily for 6 weeks and were examined for Lobene Composite Stain Index scores, with statistical analysis used at a significance of P < .001. RESULTS: In an in vitro stain prevention study, Colgate TotalSF performed 26% and 35% better than a competitor paste and nonabrasive SnF2 gel, respectively. In a clinical study, Colgate TotalSF use showed statistically significant extrinsic tooth stain reductions by 17.5% (3 weeks) and 27.8% (6 weeks) relative to regular fluoride toothpaste. No adverse effects were reported. CONCLUSIONS: The results indicate that the stabilized Colgate TotalSF performed statistically better than other SnF2 pastes in an in vitro study, and statistically better than a regular fluoride toothpaste in a clinical study. PRACTICAL IMPLICATIONS: Colgate TotalSF offers an SnF2-based therapeutic dentifrice with notable performance in stain prevention and removal.

Effect of a stannous fluoride toothpaste on dentinal hypersensitivity: In vitro and clinical evaluation.

BACKGROUND: The authors conducted an in vitro and a clinical study to assess the effect of a toothpaste containing stannous fluoride to occlude dentin tubules and reduce dentinal hypersensitivity. METHODS: For the in vitro study, the authors treated the surface of human dentin specimens with test or control toothpaste slurries and then evaluated them by using various spectroscopic techniques. For the clinical study, male and female participants who met the inclusion criteria brushed their teeth twice daily for 1 minute with test or control toothpaste. The authors assessed dentinal hypersensitivity by using tactile and air blast stimuli at baseline and after 4 and 8 weeks. All statistical tests of hypotheses were 2 sided, with a significance level of α set at .05. RESULTS: Results from in vitro studies showed that the test toothpaste effectively occluded the dentinal tubules with a deposit consisting of tin, zinc, phosphate, and silicon. The test and control toothpastes occluded the tubules 82% and 35%, respectively. Clinically, at the 4- and 8-week examinations, the test toothpaste provided statistically significant (P < .001) improvements in tactile dentinal hypersensitivity scores of 27.8% and 42.0% and in air blast hypersensitivity scores of 21.4% and 32.3%, respectively, relative to the control toothpaste. CONCLUSIONS: The in vitro results indicate the toothpaste containing 0.454% stannous fluoride effectively coated dentin surfaces and occluded patent dentin tubules. Compared with the control toothpaste, the test toothpaste provided a significant reduction in dentinal hypersensitivity after 8 weeks of product use. PRACTICAL IMPLICATIONS: A multi-benefit option for patients with dentinal hypersensitivity.

Use of a toothpaste containing 8% arginine and calcium carbonate for immediate and lasting relief of dentin hypersensitivity: A simple and effective in-office procedure.

PURPOSE: To evaluate the effectiveness in reducing dentin hypersensitivity (DH) of a commercial toothpaste containing 8% arginine, calcium carbonate and fluoride when applied by a dental professional immediately prior to a professional dental prophylaxis and again after subjects brushed twice daily with the toothpaste at home for 2 weeks, and additionally to assess whether the % reductions in DH observed in the study are comparable to those found in previously published pivotal studies. METHODS: This clinical study was a single-center, user-blind, monadic study conducted in Mississauga, Canada. Adult subjects who presented with 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) and met all inclusion and exclusion criteria were entered into the study. Immediately following baseline assessment, qualifying subjects received a single topical application of the test toothpaste to two selected hypersensitive teeth by a dental professional using a fingertip and massage for 1 minute per tooth, after which they received a professional dental prophylaxis. Subjects then brushed at-home twice daily for 1 minute with their assigned toothpaste for a period of 2 weeks. Tactile and air blast sensitivity examinations were conducted after the dental cleaning procedure and again after 2 weeks of routine twice daily tooth brushing. RESULTS: 39 subjects complied with the protocol and completed the clinical study. Immediately post-prophylaxis, subjects exhibited statistically significant reductions from baseline of 228.9% (P< 0.001) in tactile hypersensitivity and 48.9% (P< 0.001) in air blast hypersensitivity. Furthermore, after brushing twice daily (morning and evening) for a period of 2 weeks, subjects exhibited statistically significant reductions from baseline of 317.8% (P< 0.001) in tactile hypersensitivity and 90.1% (P< 0.001) in air blast hypersensitivity. These results are consistent with the results of previously published clinical studies, which demonstrated similar % reductions in DH to a single in-office professional application of the desensitizing prophylaxis paste and to a single direct topical self-application of the desensitizing toothpaste. CLINICAL SIGNIFICANCE: The results of this clinical study, together with the results of published pivotal studies, demonstrate that a desensitizing toothpaste containing 8% arginine and calcium carbonate, with or without fluoride, provides statistically significant reductions in dentin hypersensitivity when applied by a dental professional prior to a professional dental prophylaxis. The results also demonstrate that this desensitizing toothpaste provides statistically significant reductions in dentin hypersensitivity when used subsequently as an adjunct to routine twice daily tooth brushing.

The Effects of Two New Dual Zinc plus Arginine Dentifrices in Reducing Oral Bacteria in Multiple Locations in the Mouth: 12-Hour Whole Mouth Antibacterial Protection for Whole Mouth Health.

OBJECTIVES: To compare the effects of two new fluoride toothpastes with Dual Zinc plus Arginine to the effects of a fluoride control toothpaste in reducing bacteria in oral biofilm on teeth and in multiple soft tissue locations, as well as in saliva, 12 hours after 14 and 29 days of product use. METHODS: A randomized, single-center, three-cell, double-blind, parallel-group design was employed. The study protocol was approved by an Institutional Review Board. One hundred eighty adult subjects who met inclusion and exclusion criteria and signed an informed consent form were enrolled in the study. Subjects were randomly assigned to one of the three study products: 1) 0.96% zinc (zinc oxide, zinc citrate), 1.5% L-arginine and 1450 ppm fluoride as sodium fluoride in a silica base, Test 1; 2) 0.96% zinc (zinc oxide, zinc citrate), 1.5% L-arginine and 1000 ppm fluoride as sodium fluoride in a silica base, Test 2; and 3) 1450 ppm fluoride as sodium fluoride in a silica base, Control, for twice-daily use during tooth brushing. Oral samples were collected from the teeth, tongue, oral buccal mucosa, gingiva, and saliva at baseline and 12 hours after 14 and 29 days of assigned product use and were processed, serially diluted, plated, incubated, and scored for viable bacteria. Statistical analyses were performed separately for each sample site using ANOVA and ANCOVA for within- and between-treatment comparisons, respectively. RESULTS: One hundred seventy-three subjects completed the study. Relative to subjects in the Control group, subjects in the two Test groups exhibited statistically significant reductions of 29-41% in numbers of bacteria in each of the five sample areas, 12 hours after 29 days of product use. Similar results were seen after 14 days of product use, but some differences were not statistically significant, indicating that the effects of these zinc-based toothpastes build over time with continued use. The two Test toothpastes were shown to be clinically equivalent using the Fieller's confidence interval test. CONCLUSIONS: Toothpastes containing 0.96% zinc (zinc oxide, zinc citrate), 1.5% L-arginine and either 1450 ppm or 1000 ppm fluoride as sodium fluoride in a silica base provide statistically significant reductions in oral bacteria on the teeth, tongue, cheeks, and gums, as well as in saliva, compared to toothpaste with fluoride alone, 12 hours after 29 days of twice-daily tooth brushing. The results demonstrate that regular and continued twice-daily use of these new toothpastes provide 12-hour whole mouth antibacterial protection for whole mouth health.

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 a Soft Toothbrush with Tapered-tip Bristles and an ADA Reference Toothbrush on Established Gingivitis and Supragingival Plaque over a 12-Week Period.

OBJECTIVES: Evaluation of the efficacy of a soft toothbrush with tapered-tip bristles (Test Toothbrush) and an ADA reference soft toothbrush (ADA Toothbrush) on established gingivitis and supragingival plaque over a 12-week period. METHODS: This randomized, single-center, examiner-blind, two-cell, parallel clinical research study assessed plaque removal by the comparison of pre- to- post-brushing after a single use, and again after six- and 12-weeks' use, using the Quigley-Hein Plaque Index, Turesky Modification. The study also assessed gingivitis after six weeks and 12 weeks using the Löe & Silness Gingival Index. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Subjects had the study procedure explained to them both orally and by written instructions. Subjects then gave written consent to participate before entry into the study. Following an examination for plaque (pre-brushing) and gingivitis (baseline), the subjects were randomized into two balanced groups, each group assigned to one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute under supervision with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for plaque (post-brushing). Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS: Seventy-one (71) subjects complied with the protocol and completed the clinical study. Compared to the ADA Toothbrush, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 71.1% in whole mouth plaque index scores, 43.8% in plaque severity index scores, and 81.3% in interproximal sites plaque scores after a single tooth brushing. After six weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 700% in whole mouth gingival index scores, 700% in gingivitis severity index scores, and 400% in interproximal sites gingival scores compared to the ADA Toothbrush. Also after six weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 188.9% in whole mouth plaque index scores, 165% in plaque severity index scores, and 203% in interproximal sites plaque scores compared to the ADA Toothbrush. After 12 weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 266.7% in whole mouth gingival index scores, 300% in gingivitis severity index scores, and 250% in interproximal sites gingival scores compared to the ADA Toothbrush. Also after 12 weeks' use, the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions of 158.1% in whole mouth plaque index scores, 143.5% in plaque severity index scores, and 145.4% in interproximal sites plaque scores compared to the ADA Toothbrush. CONCLUSIONS: This study demonstrated that a soft toothbrush with tapered-tip bristles provided a significantly greater reduction in supragingival plaque after a single tooth brushing, as well as after six and 12 weeks of twice-daily use, compared to the ADA Toothbrush. After six and 12 weeks of twice-daily use, it also provided a significantly greater reduction in gingivitis as compared to the ADA Toothbrush.

Comparative Efficacy of a Soft Toothbrush with Tapered-tip Bristles to an ADA Reference Toothbrush on Gingival Abrasion over a 12-Week Period.

OBJECTIVES: Evaluation of the impact of a soft toothbrush with tapered-tip (Test Toothbrush) bristles and an ADA reference toothbrush (ADA Toothbrush) on gingival abrasion over a 12-week period. METHODS: This was a randomized, single-center, examiner-blind, two-cell, parallel clinical research study and used the Danser Gingival Abrasion Index to assess the level of gingival abrasion after a single brushing, as well as after six weeks and 12 weeks of twice-daily brushing. Adult male and female subjects from the Central New Jersey, USA area refrained from all oral hygiene procedures for 24 hours. They reported to the study site after refraining from eating, drinking, and smoking for four hours. Following a qualifying examination using plaque and gingivitis scores along with a baseline gingival abrasion examination, subjects were randomized into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for one minute, under supervision, with their assigned toothbrush and a commercially available fluoride toothpaste (Colgate© Cavity Protection Toothpaste), after which they were again evaluated for gingival abrasion. Subjects were dismissed from the study site with their assigned toothbrush and toothpaste, and instructed to brush twice daily at home for the next 12 weeks. The subjects were instructed to brush for one minute during each tooth brushing. The subjects reported to the study site after six weeks and 12 weeks of product use, at which time they were evaluated for gingival abrasion. RESULTS: Seventy-one (71) subjects complied with the protocol and completed the clinical study. The results of this study showed that the Test Toothbrush provided statistically significantly (p < 0.05) greater reductions in gingival abrasion scores as compared to the gingival abrasion scores of the ADA Toothbrush after a single tooth brushing, after six weeks, and after 12 weeks of product use (75.0%, 85.5%, 73.9%, respectively). CONCLUSIONS: The soft toothbrush with tapered-tip bristles produced significantly less gingival abrasion after 12 weeks of product use as compared to the ADA reference toothbrush.

Control of dentin/root sensitivity during non-surgical and surgical periodontal treatment.

AIM: To determine the efficacy of a desensitizing regimen compared to a control in preventing the occurrence and/or alleviating dentin/root sensitivity (DRS) following non-surgical (NSPT) and surgical periodontal treatment (SPT). METHODS: Seventy-four chronic-periodontitis patients (CPP) were randomized into a test group (n = 38) using an in-office prophylaxis paste and a toothpaste at home both containing 8% arginine and calcium carbonate (Pro-Argin(™) Technology) or into a control group (n = 36) receiving a fluoride-free prophylaxis paste and a fluoride toothpaste. The examiner applied the assigned paste onto selected teeth for 3 s following NSPT and for 60 s before flap closure. Patients brushed with the assigned toothpaste twice daily throughout the study. DRS to air stimulus was assessed by the Schiff scale (0-3) and the Visual Analog Scale (VAS: 0-100 mm) six times over 17 weeks. RESULTS: In the test group, VAS scores significantly decreased at 8, 11 and 17 weeks from baseline (p ≤ 0.003) and Schiff scores at 8 and 11 weeks from baseline (p ≤ 0.014). The control group exhibited significant increases in VAS and Schiff during the study period (p ≤ 0.006). Marked inter-group differences were noted at all time points (p < 0.001). CONCLUSIONS: The combined use of desensitizing products (8% arginine and calcium carbonate) in-office and at-home prevented DRS development and maintained this effect for 17 weeks following NSPT and SPT.

Efficacy of two fluoride-free, alcohol-free mouthwashes containing 0.075% or 0.07% CPC in controlling established dental plaque and gingivitis over a 6-week period on adults in Puerto Rico.

PURPOSE: To evaluate the clinical efficacy of two commercially available, fluoride-free, alcohol-free mouthwashes containing either 0.075% or 0.07% cetylpyridinium chloride (CPC) in controlling established dental plaque and gingivitis compared to a non-antibacterial control mouthwash. METHODS: A 6-week double-blind, randomized clinical trial was conducted in Trujillo Alto, Puerto Rico. Recruited subjects were randomly assigned to one of three treatment groups: (1) a fluoride-free, alcohol-free mouthwash containing 0.075% CPC (TG); (2) a fluoride-free, alcohol-free mouthwash containing 0.07% CPC (PC); and (3) a fluoride-free, alcohol-free mouthwash without antibacterial agent (NC). Subjects were instructed to rinse with the assigned mouthwash, after tooth brushing, twice daily (morning and evening). After 4 and 6 weeks of product use, subjects were examined for gingivitis (Whole Mouth Gingival, Gingival Interproximal, Gingival Severity Indexes) and plaque (Whole Mouth Plaque, Plaque Interproximal, and Plaque Severity Indexes) parameters. ANCOVA and post hoc Tukey's pair-wise comparisons (α = 0.05) were performed for treatment group comparisons. RESULTS: A total of 132 subjects were screened; 120 were enrolled; and 116 completed the study. After 6 weeks of product use, participants who rinsed with the CPC-containing mouthwashes exhibited statistically significant (P < 0.05) reductions in all the gingivitis and plaque parameters evaluated, whereas in those using the non-antibacterial mouthwash, significant reductions were only observed in whole mouth and interproximal plaque scores. No statistically significant (P > 0.05) differences were observed, with respect to the gingival and plaque parameters, between the two CPC-containing mouthwashes.

Efficacy of CPC and essential oils mouthwashes compared to a negative control mouthwash in controlling established dental plaque and gingivitis: A 6-week, randomized clinical trial.

PURPOSE: To evaluate the clinical efficacy of a mouthwash containing 0.075% cetylpyridinium chloride (CPC) in a fluoride-free, alcohol-free base and a mouthwash containing essential oils in a fluoride-free, 21.6% alcohol base as compared to a fluoride-free, alcohol-free non-antibacterial mouthwash in controlling established dental plaque and gingivitis after 6 weeks of twice daily use. METHODS: A 6-week, parallel-group, randomized double blind clinical trial was conducted in Santo Domingo, Dominican Republic. Recruited subjects were randomly assigned to one of three treatment groups: (1) a mouthwash containing 0.075% CPC in a fluoride-free, alcohol-free base (CPC); (2) a commercially-available mouthwash containing essential oils in a fluoride-free, 21.6% alcohol base (EO); or (3) a fluoride-free, alcohol-free non-antibacterial mouthwash (NC). Subjects were instructed to rinse with the assigned mouthwash, after tooth brushing, twice daily (morning and evening). After 4 and 6 weeks of product use, subjects were examined for gingivitis (Whole Mouth Gingival, Gingival Interproximal, Gingival Severity Indexes) and plaque (Whole Mouth Plaque, Plaque Interproximal, and Plaque Severity Indexes) parameters. For treatment group comparisons, ANCOVA and post hoc Tukey's pair-wise comparisons (α = 0.05) were performed. RESULTS: 132 subjects were screened; 120 were enrolled; and 116 completed the study. After 6 weeks of product use, subjects using the CPC and EO mouthwashes exhibited statistically significant (P < 0.001) reductions of all gingival and plaque measurements compared to subjects using the NC mouthwash. Subjects using the CPC mouthwash did not exhibit a statistically significant (P > 0.05) reduction with respect to gingival severity and all plaque measures (Whole, Interproximal, and Severity) when compared to EO mouthwash. Subjects using the CPC mouthwash exhibited statistically significant (P < 0.05) reductions in Gingival Index scores of 5.1% (P = 0.005), and Gingival Interproximal Index scores of 5.5% (P = 0.016) relative to subjects using the EO mouthwash. These reductions were not considered clinically significant.

Randomized clinical trial of two oral care regimens in reducing and controlling established dental plaque and gingivitis.

PURPOSE: To evaluate the efficacy of a test regimen (TR) integrating the use of a commercially available triclosan, PVM/MA copolymer, and sodium fluoride containing toothpaste, an alcohol-free, fluoride-free cetylpyridinium chloride (CPC) mouthwash, and a manual toothbrush with cheek and tongue cleaner compared to a negative control regimen (NCR) integrating a commercially available 0.76% sodium monofluorophosphate toothpaste, a manual toothbrush and a fluoride-free and alcohol-free non-antibacterial mouthwash in the reduction and control of established plaque and gingivitis after 4 weeks of product use. METHOD: A 4-week, two-cell, double-blind, parallel-group, randomized clinical study was conducted in Cedar Knolls, New Jersey, USA. Recruited subjects were randomly assigned to two regimens: (1) a commercially available toothpaste containing triclosan, PVM/MA copolymer, and 0.243% sodium fluoride, a manual toothbrush with cheek and tongue cleaner, and commercially available mouthwash containing 0.075% CPC in a fluoride-free and alcohol-free base (TR), or (2) a commercially available 0.76% sodium monofluorophosphate toothpaste, a manual toothbrush with rounded/polished bristles, and a fluoride-free and alcohol-free non-antibacterial mouthwash (NCR). Subjects were examined for dental plaque and gingivitis. Gingival, Gingival Severity, Gingival Interproximal, Plaque, Plaque Severity and Plaque Interproximal Index scores were calculated. For regimen comparison, independent t-test and ANCOVA analyses were performed. RESULTS: 130 subjects were screened; 120 enrolled; and 115 subjects completed the randomized clinical trial (RCT). After 4 weeks of product use, subjects using TR exhibited statistically significant (P < 0.001) reductions of 22.3%, 27.8% and 20.4% in mean Gingival, Gingival Severity and Gingival Interproximal Index scores, respectively, as compared to subjects using NCR. After 4 weeks of product use, subjects using TR exhibited statistically significant (P < 0.001) reductions of 28.2%, 60.7% and 27.6% in mean Plaque, Plaque Severity and Plaque Interproximal Index scores, respectively, as compared to subjects using NCR.

The efficacy of two oral hygiene regimens in reducing oral malodour: a randomised clinical trial.

OBJECTIVES: This study compared the efficacy of two oral hygiene regimens in reducing oral malodour and the proportions of bacterial species involved in the production of volatile sulphur compounds. MATERIAL AND METHODS: Seventy subjects who participated in a halitosis-induction phase and achieved an organoleptic score of ≥ 3.0 [time point 0 (T0)] randomised into two groups: brushing with regular fluoride toothpaste alone (control group) or brushing with regular fluoride toothpaste followed by rinsing with a 0.075% cetylpyridinium chloride (CPC) mouthwash (CPC group). Subjects followed their assigned oral hygiene regimen for 21 days. Then, they underwent an organoleptic examination and measurement of volatile sulphur compounds (VSCs) using a portable gas chromatograph, 12 hours after their last oral hygiene procedure (T1) and 4 hours after an on-site oral hygiene (T2). Microbiological samples (supragingival biofilm, tongue coating and saliva) were analysed using checkerboard DNA-DNA hybridisation. RESULTS: Both therapies statistically significantly improved the organoleptic scores (P < 0.05), but the VSC levels and/or concentrations were reduced only in the CPC group (P < 0.05). In subjects rinsing with CPC, oral malodour scores were reduced by 49% at the 4-hour assessment (T2) compared with those not rinsing (P < 0.05). Red-complex pathogens were reduced more effectively in the CPC group than in the control group. CONCLUSIONS: Brushing followed by rinsing with a 0.075% CPC mouthwash provided statistically significantly greater reductions in oral malodour, measured organoleptically and instrumentally, and in the proportions of red-complex species when compared with brushing alone.

Comparing three toothpastes in controlling plaque and gingivitis: A 6-month clinical study.

PURPOSE: To investigate the clinical efficacy of three toothpastes in controlling established gingivitis and plaque over 6 months. METHODS: 135 subjects were enrolled in a single-center, double-blind, parallel group, randomized clinical study. Subjects were randomly assigned to one of three treatments: triclosan/copolymer/fluoride dentifrice containing 0.3% triclosan, 2.0% copolymer and 1,450 ppm F as sodium fluoride in a silica base; herbal/bicarbonate dentifrice containing herbal extract and 1,400 ppm F as sodium fluoride in a sodium bicarbonate base; or fluoride dentifrice containing 450 ppm F as sodium fluoride, and 1,000 ppm F as sodium monofluorophosphate. Subjects were instructed to brush their teeth twice daily for 1 minute for 6 months. RESULTS: After 6 months, subjects assigned to the triclosan/copolymer/fluoride group exhibited statistically significant reductions in gingival index scores and plaque index scores as compared to subjects assigned to the herbal/bicarbonate group by 35.4% and 48.9%, respectively. There were no statistically significant differences in gingival index and plaque index between subjects in the herbal/ bicarbonate group and those in the fluoride group. The triclosan/copolymer/fluoride dentifrice was statistically significantly more effective in reducing gingivitis and dental plaque than the herbal/bicarbonate dentifrice, and this difference in efficacy was clinically meaningful.

Randomized clinical trial of the efficacy of dentifrices containing 1.5% arginine, an insoluble calcium compound and 1450 ppm fluoride over two years.

OBJECTIVE: A double blind, randomized, unsupervised, parallel-group clinical trial was conducted on over 5,500 children in Sichuan Province, China. This clinical trial compared the anti-caries efficacy of two test dentifrices to that of a control dentifrice. METHODS: The test dentifrices contained 1.5% arginine, 1450 ppm fluoride as sodium monofluorophosphate (MFP), and an insoluble calcium compound (either dicalcium phosphate or calcium carbonate). The positive control dentifrice contained 1450 ppm fluoride as sodium fluoride (NaF), in a silica base. The children were randomly assigned one of the toothpastes, and children residing in the same household were assigned the same dentifrice to use at home, twice a day. RESULTS: Three calibrated dentists examined the children at baseline, as well as after one and two years of product use. After one year of product use, there were no statistically significant differences among the three groups with respect to decayed, missing, and filled teeth (DMFT) or to decayed, missing, and filled surfaces (DMFS). After two years of product use, subjects in the two test groups using the dentifrices containing 1.5% arginine, 1450 ppm fluoride as MFP, and an insoluble calcium compound had a statistically significant reduction in DMFT increments of 20.5% and in DMFS increments of 19.6% when compared to subjects in the group using the positive control dentifrice. After two years, there were no statistically significant differences with respect to DMFT or DMFS between the two groups using the dentifrices containing 1.5% arginine, 1450 ppm fluoride as MFP, and an insoluble calcium compound. CONCLUSION: The use of the two test dentifrices demonstrated significant reductions in decayed, missing, and filled teeth and surfaces, however there was no statistically significant different between the two test dentifrices clinically after two years of using the toothpastes. The results of this two-year clinical investigation support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound, and 1450 ppm fluoride as MFP provide superior protection against caries lesion cavitation compared to a positive control dentifrice containing only 1450 ppm fluoride as NaF.

Randomized controlled trial comparing a powered toothbrush with distinct multi-directional cleaning action to a manual flat trim toothbrush.

PURPOSE: To compare the plaque and gingivitis efficacy of a power toothbrush with distinct multi-directional cleaning action (Colgate® ProClinical® A1500 Power Toothbrush) against a manual flat-trim toothbrush (Oral-B Indicator). METHODS: This randomized control trial was a single-center, examiner-blind, parallel-group, design and assessed plaque removal after a single brushing, as well as plaque removal and gingivitis reduction after 4 weeks and 12 weeks of brushing. Qualifying subjects used their assigned toothbrush to brush their teeth under supervision after which they were evaluated for plaque (post-brushing). Over the next 12 weeks, subjects brushed unsupervised at home with their assigned toothbrush. After 4 weeks and 12 weeks, subjects returned to the center for plaque and gingivitis examinations. RESULTS: 80 subjects were screened for eligibility and randomized into the study. 79 subjects completed the study. Both toothbrushes provided statistically significant reductions in all plaque index scores at all time points in comparison to the pre-brushing scores. After 4 weeks and 12 weeks, statistically significant reductions in gingivitis and gingivitis severity scores were observed for subjects using the power toothbrush, whereas statistically significant increases in gingivitis and gingivitis severity were observed for subjects using the manual toothbrush. In conclusion, relative to the manual toothbrush, the power toothbrush provided statistically significantly (P < 0.05) greater removal of plaque: whole-mouth (131%), gumline (97.4%), and interproximal (220%), as well as reductions in gingivitis (400%), and gingivitis severity (320%) after 12 weeks of use. Compared to the manual flat-trim toothbrush, the power toothbrush with distinct multi-directional cleaning action demonstrates statistically and clinically significantly greater levels of plaque removal and gingivitis reduction at all time points.

Efficacy of two different toothbrush heads on a sonic power toothbrush compared to a manual toothbrush on established gingivitis and plaque.

OBJECTIVE: To evaluate the efficacy of a power toothbrush with distinct multi-directional cleaning action using two different heads (Colgate ProClinical C200 toothbrush with either a triple clean head or a sensitive head) as compared to a manual flat-trim toothbrush (Oral B Indicator toothbrush) on supragingival plaque and established gingivitis. METHODS: This examiner-blind, randomized, controlled, three-treatment, parallel-group clinical research study assessed plaque removal via the comparison of pre- to post-brushing after a single use and again after four weeks of use, using the Rustogi Modified Navy Plaque Index. This study also assessed gingivitis at four weeks using the Löe-Silness Gingival Index. Qualifying adult male and female subjects from the central New Jersey, USA area reported to the study site after refraining from any oral hygiene procedures for 24 hours, and from eating, drinking, and smoking for four hours. Following an examination for plaque and gingivitis, they were randomized into three balanced groups. Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush and a commercially available toothpaste (Colgate Cavity Protection toothpaste), after which they were again evaluated for plaque. Subjects were dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next four weeks. They reported to the study site after four weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS: One hundred twenty (120) enrolled subjects complied with the protocol and completed the clinical study. The results of the study indicated that all three test products provided statistically significant reductions in pre-brushing to post-brushing plaque scores for whole mouth and interproximal sites after a single use. For gingival margin plaque sites, only the Colgate ProClinical C200 toothbrush, with either the triple clean head or the sensitive head, provided statistically significant reductions in pre- to post-brushing plaque scores. After four weeks of product use, all three test products provided statistically significant reductions in baseline to four-week whole mouth and interproximal site plaque scores, but only the Colgate ProClinical C200 toothbrush, with either the triple clean head or the sensitive head, provided a statistically significant reduction in plaque scores at gingival margin sites. All three test products provided statistically significant reductions in gingival and gingivitis severity index scores after four weeks of product use. Relative to the manual toothbrush group, after a single tooth brushing the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in whole mouth plaque index scores (51.9% and 59.3%, respectively), in gingival margin plaque index scores (700% and 650%, respectively), and interproximal plaque index scores (64.2% and 60.4%, respectively). Relative to the manual toothbrush group, after four weeks of use the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in whole mouth plaque index scores (78.6%, and 82.1%, respectively), in gingival margin plaque index scores (3700% and 3400%, respectively), and interproximal plaque index scores (50.8% and 52.5%, respectively). Relative to the manual toothbrush group, after four weeks of use the Colgate ProClinical C200 toothbrush, with either the triple clean head or sensitive head, provided statistically significantly greater reductions in gingival index scores of 900% and 833%, respectively, and in gingivitis severity index scores of 466.7% and 600%, respectively. All statistically significant reductions were at the p ≤ 0.05 level. There were no statistically significant differences between the scores of the Colgate ProClinical C200 toothbrush with triple clean head and the scores of the Colgate ProClinical C200 toothbrush with sensitive head at any comparison time point. CONCLUSION: The Colgate ProClinicaI C200 toothbrush, with either a triple clean head or a sensitive head, provides statistically significant and clinically relevant levels of efficacy in the removal of supragingival dental plaque in the whole mouth, at the gingival margin, and interproximally after a single tooth brushing and after four weeks of use, as well as a statistically significantly greater level of efficacy in the reduction of gingivitis and gingival bleeding when compared to a manual flat-trim toothbrush.

Beneficial effects of an arginine-calcium carbonate desensitizing paste for treatment of dentin hypersensitivity.

PURPOSE: To evaluate the clinical efficacy of a single professional application of a Pro-Relief desensitizing fluoride-free paste containing 8% arginine and calcium as compared to a fluoride-free prophylaxis paste on dentin hypersensitivity reduction in adults with a clinical diagnosis of dentin hypersensitivity. METHODS: This single-center, parallel group, double-blind and randomized clinical study conducted in Santo Domingo, Dominican Republic included 50 (25 per group) adult male and female subjects. Each study subject had two teeth hypersensitive to air blast stimuli when applied directly at its cervical surface (gingivo-facial 1/3). An air blast hypersensitivity score equal or greater to 2 (Schiff Cold Air Sensitivity Scale) was randomly assigned to one of two treatment groups (1) Pro-Relief in-office desensitizing fluoride-free paste containing 8% arginine and calcium carbonate (Test Paste group), and (2) a fluoride-free prophylaxis paste (Control Paste group). Prior to their baseline examination, subjects were instructed to return to the clinical facility having refrained from eating and drinking for 2 hours. An assessment of air blast hypersensitivity and examinations of oral soft and hard tissue were performed at the baseline. Subjects were provided a professional in-office prophylaxis with their assigned prophylaxis paste. A post hypersensitivity examination was performed immediately after the oral prophylaxis. RESULTS: All subjects completed the study. At the post-hypersensitivity examination, subjects assigned to the Test Paste group and Control Paste group both exhibited statistically significant (P = 0000) reductions (compared to baseline), to air blast hypersensitivity of 44.7% and 25.6%, respectively. At the post-hypersensitivity examination, subjects in the Test Paste group exhibited a statistically significant (P = 0.005) reduction of 24.4% in mean air blast hypersensitivity scores as compared to the Control Paste group.