Antibacterial and clinical effectiveness of a mouthwash with a novel active system of amine + zinc lactate + fluoride: a randomized controlled trial.

OBJECTIVES: To support the daily oral hygiene of patients experiencing gum inflammation, a new mouthwash was developed containing an amine + zinc lactate + fluoride system. In vitro and clinical efficacy was assessed using traditional methods as well as using novel site-specific and subject-specific analyses of the clinical data. MATERIALS AND METHODS: This mouthwash was evaluated in a 12-h biofilm regrowth assay against a negative control mouthwash and in a 6-month plaque and gingivitis clinical study as compared to a negative control mouthwash. Analyses of healthy versus inflamed sites, visible plaque versus non-visible plaque sites, as well as subject-level evaluations bring new perspectives to the overall performance of this mouthwash and its significance from a patient outcome perspective. RESULTS: Studies demonstrated that this new mouthwash provided long-term (12-h) antibacterial activity after single application in vitro and reduced clinically all plaque and gingivitis parameters after 3 months and 6 months of use when compared to the negative control mouthwash. Examination of site-level and subject-level data determined that this mouthwash significantly increased the number of healthy sites in the oral cavity and significantly improved the gum health of subjects in the study, as compared to the negative control mouthwash. CONCLUSIONS: In vitro and clinical research has demonstrated the antibacterial and clinical benefits of this mouthwash containing an amine compound + zinc lactate + fluoride system. CLINICAL RELEVANCE: Our subject-specific and site-specific analyses provide the dental practitioner with tools that can be used to guide patients who suffer from gingivitis toward optimal product selection and use. CLINICAL TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (reference no. NCT05821712).

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.

Efficacy of two mouthwashes with cetylpyridinium chloride: a controlled randomized clinical trial.

This study aimed to evaluate the anti-plaque and anti-gingivitis effects of two mouthwashes containing cetylpyridinium chloride (CPC), in comparison to negative control mouthwash. One hundred and twenty subjects were randomly assigned to study groups: test (0.075% CPC and 0.28% zinc lactate), positive control (0.07% CPC) and negative control mouthwash without CPC. All volunteers were examined by a calibrated examiner for the Quigley-Hein Plaque Index (Turesky modification) and Löe-Silness Gingival Index (GI). Gingival severity was also measured by the percentage of sites with positive gingival bleeding. During six weeks, oral hygiene consisted of brushing twice daily with a toothbrush and toothpaste and rising with their assigned mouthwash. Plaque and gingival parameters were assessed at baseline, after four and six weeks of product use. Statistical analyses were performed separately for plaque and gingival indices, by ANOVA, paired t-test and ANCOVA (α < 0.05). After 4 and 6 weeks, all mouthwashes groups presented statistically significant reductions in plaque and gingival parameters as compared to baseline. In comparison to the positive control, the test group presented additional reductions in dental plaque of 19.8% and 16.8%, after 4 and 6 weeks, respectively. For GI, the additional reductions in the test group were 9.7% and 14.3%, at 4 and 6 weeks, respectively. The test group showed additional reduction of 35.3% and 54.5% in the gingival severity, at week 4 and 6, respectively. It is concluded that the mouthwash containing CPC and zinc lactate presents significant anti-plaque and anti-gingivitis effects as compared to positive and negative control mouthwashes.

Effectiveness of a pre-procedural mouthwash in reducing bacteria in dental aerosols: randomized clinical trial

The aim of this randomized, single blinded clinical trial was to evaluate the effect of a pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and sodium fluoride (F) in the reduction of viable bacteria in oral aerosol after a dental prophylaxis with ultrasonic scaler. Sixty systemically healthy volunteers receiving dental prophylaxis were randomly assigned to one of the following experimental groups (15 per group): (i) rinsing with 0.075% CPC, 0.28% Zn and 0.05% F (CPC+Zn+F), (ii) water or (iii) 0.12% chlorhexidine digluconate (CHX), and (iv) no rinsing. Viable bacteria were collected from different locations in the dental office on enriched TSA plates and anaerobically incubated for 72 hours. The colonies were counted and species were then identified by Checkerboard DNA-DNA Hybridization. The total number of colony-forming units (CFUs) detected in the aerosols from volunteers who rinsed with CPC+Zn+F or CHX was statistically significantly (p<0.05) lower than of those subjects who did not rinse or who rinsed with water. When all locations were considered together, the aerosols from the CPC+Zn+F and CHX groups showed, respectively, 70% and 77% fewer CFUs than those from the No Rinsing group and 61% and 70% than those from the Water group. The mean proportions of bacterial species from the orange complex were statistically significantly (p<0.05) lower in aerosols from the CPC+Zn+F and CHX groups compared with the others two groups. In conclusion, the mouthwash containing CPC+Zn+F, is effective in reducing viable bacteria in oral aerosol after a dental prophylaxis with ultrasonic scaler.

Effectiveness of a pre-procedural mouthwash in reducing bacteria in dental aerosols: randomized clinical trial

Abstract The aim of this randomized, single blinded clinical trial was to evaluate the effect of a pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and sodium fluoride (F) in the reduction of viable bacteria in oral aerosol after a dental prophylaxis with ultrasonic scaler. Sixty systemically healthy volunteers receiving dental prophylaxis were randomly assigned to one of the following experimental groups (15 per group): (i) rinsing with 0.075% CPC, 0.28% Zn and 0.05% F (CPC+Zn+F), (ii) water or (iii) 0.12% chlorhexidine digluconate (CHX), and (iv) no rinsing. Viable bacteria were collected from different locations in the dental office on enriched TSA plates and anaerobically incubated for 72 hours. The colonies were counted and species were then identified by Checkerboard DNA–DNA Hybridization. The total number of colony-forming units (CFUs) detected in the aerosols from volunteers who rinsed with CPC+Zn+F or CHX was statistically significantly (p<0.05) lower than of those subjects who did not rinse or who rinsed with water. When all locations were considered together, the aerosols from the CPC+Zn+F and CHX groups showed, respectively, 70% and 77% fewer CFUs than those from the No Rinsing group and 61% and 70% than those from the Water group. The mean proportions of bacterial species from the orange complex were statistically significantly (p<0.05) lower in aerosols from the CPC+Zn+F and CHX groups compared with the others two groups. In conclusion, the mouthwash containing CPC+Zn+F, is effective in reducing viable bacteria in oral aerosol after a dental prophylaxis with ultrasonic scaler.

Efficacy of two mouthwashes with cetylpyridinium chloride: a controlled randomized clinical trial

Abstract This study aimed to evaluate the anti-plaque and anti-gingivitis effects of two mouthwashes containing cetylpyridinium chloride (CPC), in comparison to negative control mouthwash. One hundred and twenty subjects were randomly assigned to study groups: test (0.075% CPC and 0.28% zinc lactate), positive control (0.07% CPC) and negative control mouthwash without CPC. All volunteers were examined by a calibrated examiner for the Quigley-Hein Plaque Index (Turesky modification) and Löe-Silness Gingival Index (GI). Gingival severity was also measured by the percentage of sites with positive gingival bleeding. During six weeks, oral hygiene consisted of brushing twice daily with a toothbrush and toothpaste and rising with their assigned mouthwash. Plaque and gingival parameters were assessed at baseline, after four and six weeks of product use. Statistical analyses were performed separately for plaque and gingival indices, by ANOVA, paired t-test and ANCOVA (α < 0.05). After 4 and 6 weeks, all mouthwashes groups presented statistically significant reductions in plaque and gingival parameters as compared to baseline. In comparison to the positive control, the test group presented additional reductions in dental plaque of 19.8% and 16.8%, after 4 and 6 weeks, respectively. For GI, the additional reductions in the test group were 9.7% and 14.3%, at 4 and 6 weeks, respectively. The test group showed additional reduction of 35.3% and 54.5% in the gingival severity, at week 4 and 6, respectively. It is concluded that the mouthwash containing CPC and zinc lactate presents significant anti-plaque and anti-gingivitis effects as compared to positive and negative control mouthwashes.

Efficacy of two soft-bristle toothbrushes in plaque removal: a randomized controlled trial.

The aim of this study was to compare the efficacy in supragingival plaque removal of two soft-bristle toothbrushes. Seventy volunteers were allocated randomly to the Colgate Slim Soft or Curaprox CS5460 toothbrush grourps. At baseline appointment, volunteers underwent plaque examination using the Rustogi Modification of the Navy Plaque Index. Under supervision, they then brushed their teeth for 1minute with their assigned toothbrushes and the plaque examination was repeated. Volunteers performed daily oral hygiene with their assigned toothbrush and a regular dentifrice provided by the researchers for 7 days. The baseline experimental procedures were then repeated. Separate analyses of variance were performed for the whole-mouth, interproximal, and gumline plaque scores (p < 0.05). No difference in baseline pre-brushing scores was found between groups. After a single toothbrushing, the mean plaque score was significantly reduced in both groups (p < 0.05), with greater reduction of whole-mouth and interproximal plaque scores observed in the SlimSoft group compared with the Curaprox group (p < 0.05). After 7 days, the SlimSoft group showed greater reduction of the whole-mouth and interproximal plaque scores compared with the Curaprox group (p < 0.05). In conclusion, the SlimSoft toothbrush presented greater efficacy in supragingival plaque removal than did the Curaprox CS5460 toothbrush, as reflected by whole-mouth and interproximal plaque scores.

Efficacy of two soft-bristle toothbrushes in plaque removal: a randomized controlled trial

Abstract The aim of this study was to compare the efficacy in supragingival plaque removal of two soft-bristle toothbrushes. Seventy volunteers were allocated randomly to the Colgate Slim Soft or Curaprox CS5460 toothbrush grourps. At baseline appointment, volunteers underwent plaque examination using the Rustogi Modification of the Navy Plaque Index. Under supervision, they then brushed their teeth for 1minute with their assigned toothbrushes and the plaque examination was repeated. Volunteers performed daily oral hygiene with their assigned toothbrush and a regular dentifrice provided by the researchers for 7 days. The baseline experimental procedures were then repeated. Separate analyses of variance were performed for the whole-mouth, interproximal, and gumline plaque scores (p < 0.05). No difference in baseline pre-brushing scores was found between groups. After a single toothbrushing, the mean plaque score was significantly reduced in both groups (p < 0.05), with greater reduction of whole-mouth and interproximal plaque scores observed in the SlimSoft group compared with the Curaprox group (p < 0.05). After 7 days, the SlimSoft group showed greater reduction of the whole-mouth and interproximal plaque scores compared with the Curaprox group (p < 0.05). In conclusion, the SlimSoft toothbrush presented greater efficacy in supragingival plaque removal than did the Curaprox CS5460 toothbrush, as reflected by whole-mouth and interproximal plaque scores.

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.

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 a mouthwash containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride compared to a negative control mouthwash on dentin hypersensitivity reduction. A randomized clinical trial.

OBJECTIVE: The objective of this eight week, single-center, two-cell, double-blind, and randomized clinical study was to evaluate the dentin hypersensitivity reduction efficacy of a mouthwash using Pro-Argin™ Mouthwash Technology containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride in an alcohol-free base ("Arginine Mouthwash") compared to an ordinary mouthwash without any active ingredients ("Negative Control"). METHODS: Qualifying subjects who presented two hypersensitive teeth with a tactile hypersensitivity score between 10 and 50 g of force, and an air blast hypersensitivity score of 2 or 3 participated in this study and were randomized into one of two treatment groups. Subjects brushed with the toothbrush and fluoride toothpaste provided and then rinsed with 20 mL of their assigned mouthwash for 30s twice daily. Subjects refrained from eating or drinking for 30 min after rinsing. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at the baseline visit and again after two weeks, four weeks and eight weeks of product use. RESULTS: Ninety (90) subjects entered and completed the eight week study. After two weeks, four weeks and eight weeks of product use, subjects in the Arginine Mouthwash group exhibited statistically significant (p<0.05) improvements in mean tactile and air blast hypersensitivity scores as compared to the Negative Control Mouthwash. CONCLUSION: The results of this study support the conclusion that the Arginine Mouthwash provides a significant reduction in dentin hypersensitivity after eight weeks of product use as compared to a Negative Control mouthwash.

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.