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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

Clinical investigation of oral malodor during long-term use of arginine-containing dentifrices.

PURPOSE: To investigate whether the long term use of two dentifrices containing arginine, an insoluble calcium compound, and fluoride: (1) 1.5% arginine and 1450 ppm F as sodium monofluorophosphate (NaMFP) in a dicalcium phosphate dihydrate (dical) base, and (2) 8.0% arginine and 1450 ppm F as NaMFP in a calcium carbonate base, results in an increase in oral malodor potentially associated with increased ammonia production from breakdown of arginine, as compared to a commercially available fluoride dentifrice without arginine (1450 ppm F as NaMFP in a dical base), after 6 months of product use. METHODS: A 6-month clinical study, with 119 subjects, was conducted in Chengdu, China, using a double blind, randomized, parallel, three-treatment design. A panel of four expert judges used a nine-point hedonic scale to evaluate breath odor using a protocol designed in concordance with the ADA Acceptance Program Guidelines for Product Used in the Management of Oral Malodor. After a baseline evaluation, study subjects who scored above the threshold value for unpleasant breath odor were stratified by score and randomized into one of three treatment groups. Subjects were provided with a soft-bristled manual toothbrush (Colgate Classic Clean Toothbrush) and brushed their teeth thoroughly in their regular and customary manner for 1 minute with their assigned dentifrice, twice daily. Before breath-odor evaluations, the subjects refrained from eating odorigenic foods and did not use dental hygiene procedures, breath mints, or mouth rinses for 48 hours and 12 hours, respectively. RESULTS: There was no statistically significant difference in oral malodor levels among subjects using the three dentifrices after 1, 3 and 6 months 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 efficacy of an arginine-calcium carbonate-MFP toothpaste to a calcium carbonate-MFP toothpaste in controlling supragingival calculus formation and gingivitis: a 6-month clinical study.

PURPOSE: To investigate whether the long-term use (6 months) of an arginine-calcium carbonate-MFP toothpaste would affect calculus formation and/or gingivitis when compared to a calcium carbonate-MFP toothpaste. METHODS: This was a double-blind clinical study. Eligible adult subjects (120) entered a 2-month pre-test phase of the study. After receiving an evaluation of oral tissue and a dental prophylaxis, the subjects were provided with a regular fluoride toothpaste, a soft-bristled adult toothbrush with instructions to brush their teeth for 1-minute twice daily (morning and evening) for 2 months. The subjects were then examined for baseline calculus using the Volpe-Manhold Calculus Index (VMI) and gingivitis using the Löe-Silness Gingival Index (GI), along with an oral tissue examination. Qualifying subjects were randomized to two treatment groups: (1) Colgate Sensitive Pro-Relief toothpaste containing 8.0% arginine, 1450 ppm MFP and calcium carbonate (Test group), or (2) Colgate Cavity Protection toothpaste containing 1450 ppm MFP and calcium carbonate (Control group). Subjects were stratified by the VMI score and gender. After a dental prophylaxis (VMI=0), the subjects entered a 6-month test phase. Each received the assigned toothpaste and a soft-bristled adult toothbrush for home use with instructions of brushing teeth for 1 minute twice daily (morning and evening). The examinations of VMI, Löe-Silness GI and oral tissues were conducted after 3 and 6 months. Prior to each study visit, subjects refrained from brushing their teeth as well as eating and drinking for 4 hours. RESULTS: 99 subjects complied with the study protocol and completed the 6-month test phase. No within-treatment comparison was performed for the VMI because it was brought down to zero after the prophylaxis at the baseline of the test phase. For the Löe-Silness GI, subjects of the Test group exhibited a significant difference from baseline at the 3- and 6-month examinations. The 3-month Löe-Silness GI of the Control group was significantly different from that of the baseline; however, its 6-month Löe-Silness GI was not statistically significantly different from the baseline values. After 3 and 6 months, there were no significant differences between the Test and Control groups with respect to the mean VMI scores; there were no statistically significant differences between the two groups with respect to the Löe-Silness GI results after 3 and 6 months of product use.

A clinical study comparing the supragingival plaque and gingivitis efficacy of a specially engineered sonic powered toothbrush with unique sensing and control technologies to a commercially available manual flat-trim toothbrush.

OBJECTIVE: This study was designed to evaluate the efficacy of a new specially engineered sonic powered toothbrush with unique sensing and control technologies, as compared to a manual flat-trim toothbrush on supragingival plaque and established gingivitis. METHODS: This examiner-blind, two-treatment, parallel clinical research study assessed plaque removal via the comparison of pre- to post-brushing after a single use, and again after four- and 12-weeks' use using the Rustogi Modification of the Modified Navy Plaque Index. This study also assessed gingivitis at four and 12 weeks using the Löe and Silness Gingival Index. Qualifying adult male and female subjects from the southern Florida 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 (pre-brushing) and gingivitis, they were randomized (for both plaque and gingivitis) into two balanced groups, each group using one of the two study toothbrushes. Subjects were instructed to brush their teeth for two minutes under supervision with their assigned toothbrush according to the manufacturer's instructions, and commercially available toothpaste (Colgate Cavity Protection Toothpaste), after which they were again evaluated for plaque (post-brushing). Subjects were then dismissed from the study site with the toothpaste and their assigned toothbrush to use at home twice daily for the next 12 weeks. They again reported to the study site after four and 12 weeks of product use, at which time they were evaluated for plaque and gingivitis. RESULTS: Seventy-six out of 82 enrolled subjects complied with the protocol and completed the clinical study. The new specially engineered sonic powered toothbrush with unique sensing and control technologies provided statistically significant reductions in gingival and gingivitis severity index scores after four and 12 weeks of product use. The manual toothbrush provided a statistically significant reduction in gingival index score only at the 12-week time point. Relative to the manual toothbrush group, after a single tooth brushing and after four and 12 weeks, the new sonic powered toothbrush provided statistically significantly greater reductions in whole mouth plaque index scores (1.6, 2.05, and 1.9 times, respectively), gingival margin plaque index scores (12.0, 90.0, and 8.2 times, respectively), and interproximal plaque index scores (2.0, 3.2, and 2.1 times, respectively). Relative to the manual toothbrush group after four and 12 weeks, the new sonic powered toothbrush provided statistically significant reductions in gingival index scores of 11.0 and 7.0 times, respectively, and in gingivitis severity index scores of 3.0 and 3.5 times, respectively. All statistically significant reductions were at the p < or = 0.05 level. CONCLUSION: The new specially engineered sonic powered toothbrush unique sensing and control technologies provides statistically significant and clinically relevant levels of efficacy in the removal of supragingival dental plaque after a single tooth brushing, and after four and 12 weeks' use. The new sonic powered toothbrush also provides statistically significantly greater levels of efficacy in the reduction of supragingival plaque, gingivitis, and gingival bleeding when compared to a manual flat-trim toothbrush.