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.

Changing the Paradigm of Daily Prevention to Achieve Whole Mouth Health in the 21st Century.

A comprehensive mechanical plaque control program - designed, monitored, and reinforced by dental professionals - can help patients achieve excellent oral hygiene and oral health. However, this approach to prevention is impractical for many individuals, so dental caries and periodontal disease are highly prevalent globally. Experts recently agreed that a toothpaste with fluoride and a plaque control agent can augment mechanical procedures to simultaneously prevent caries and periodontal disease. Notwithstanding this, it is timely to rethink prevention and oral health promotion. A new definition of oral health raises awareness of its different dimensions and empowers dentistry to move from treating disease to supporting prevention. In addition, a deeper understanding of the relationship between oral biofilms and the host facilitates new opportunities for disease prevention. The knowledge that health-associated biofilms help prevent establishment of pathogenic species, regulate the potentially damaging host response, and provide essential benefits to health and well-being is paramount to changing the paradigm of prevention of dental disease. Ecological approaches to biofilm control can reduce plaque sufficiently to reduce disease risk, while creating and supporting the beneficial functions of biofilms consistent with health. The knowledge that the oral soft tissues are the primary reservoir of bacteria for tooth recolonization and that reducing bacteria on soft tissues results in improved plaque control and consequently better oral health is also salient. Indeed, a toothpaste that delivers 12-hour protection to the hard and soft tissues (whole mouth protection) and multiple oral health benefits (whole mouth health) could become the future cornerstone of prevention. An innovative fluoride toothpaste with a Dual Zinc plus Arginine multi-functional therapeutic agent offers whole mouth protection against daily oral challenges and whole mouth health for the patient. Within a patient-centered preventive program, next to messaging that motivates towards improved self-care, this toothpaste empowers patients to achieve effective prevention of common oral diseases and better oral health compared to just brushing with an ordinary toothpaste.

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 12-week clinical study assessing the clinical effects on plaque metabolism of a dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride.

PURPOSE: To evaluate the clinical effect on plaque metabolism of a dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride compared to a commercially available dentifrice containing 1,450 ppm fluoride in a silica base. METHODS: A 12-week, parallel, randomized, double-blind study using 48 subjects was conducted at the Colgate-Palmolive Technology Center (Piscataway, NJ, USA). One group used a test dentifrice containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride as sodium monofluorophosphate (MFP), and the other group used a commercial silica dentifrice with 1,450 ppm fluoride as sodium fluoride (NaF) as a control. Plaque metabolism analyses were conducted at baseline and after 2, 4, 6, 8, and 12 weeks of assigned product use. The plaque analyses included pH measurements before and after a sucrose rinse, ammonia production and lactic acid production. RESULTS: Subjects using the test dentifrice had significantly higher plaque pH values before (P< or = 0.01) and after (P< or = 0.045) a sucrose challenge than those using the commercially available control dentifrice. Subjects using the test dentifrice also produced higher levels of ammonia and lower levels of lactic acid compared to subjects using the control dentifrice.

Mode of action studies on a new desensitizing dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride.

PURPOSE: To ascertain the mode of action of a new Pro-Argin formula desensitizing dentifrice with a gentle whitening benefit containing 8.0% arginine, a high cleaning calcium carbonate system and sodium monofluorophosphate, utilizing a range of state-of-the-art surface techniques. METHODS: Confocal laser scanning microscopy (CLSM) and scanning electron microscopy (SEM) were used to assess tubule occlusion. Electron spectroscopy for chemical analysis (ESCA) was used to identify the composition of the occlusive material. CLSM was also used to identify the location of the arginine within the occluded dentin tubule and to demonstrate the resistance of the occlusion to an acid challenge. RESULTS: The CLSM and SEM studies demonstrated that the arginine-calcium carbonate technology in this new Pro-Argin formula sensitivity dentifrice was highly effective in occluding dentin tubules. ESCA showed that the dentin surface deposit contained high levels of calcium, phosphorous, oxygen and carbonate. CLSM also confirmed that the arginine incorporated into the dentin plug, and the dentin plug resisted an acid challenge.

Recent advances in dentin hypersensitivity: clinically proven treatments for instant and lasting sensitivity relief.

PURPOSE: To provide a brief overview of the diagnosis, epidemiology, etiology and clinical management of dentin hypersensitivity, to discuss technical approaches to relieve sensitivity, with special emphasis on dentin tubule occlusion and the clinical evidence for efficacy of desensitizing toothpastes based upon this approach, and to summarize the science behind a new dentifrice technology, based upon arginine and calcium carbonate, and the clinical evidence which proves that it delivers both instant and lasting relief of dentin hypersensitivity. RESULTS: Clinical studies have shown that a new toothpaste, containing arginine and calcium carbonate (known as Pro-Argin technology) with 1450 ppm fluoride, offers clinically proven instant and lasting relief of dentin hypersensitivity. Three 8-week clinical studies have shown that this new toothpaste provides statistically significantly superior efficacy in reducing sensitivity to market leading desensitizing toothpastes containing 2% potassium ion. Importantly, three further clinical studies have shown that a single direct topical application of toothpaste to sensitive teeth, using a fingertip or cotton swab followed by 1 minute of massage, resulted in instant relief of dentin hypersensitivity and that the relief was maintained with subsequent twice-daily brushing. Mechanism of action studies have shown that this technology physically seals dentin tubules with a plug that contains arginine, calcium carbonate and phosphate. This plug, which is resistant to normal pulpal pressures and to acid challenge, effectively reduces dentin fluid flow and thereby relieves sensitivity. A new whitening variant of this desensitizing toothpaste, containing the Pro-Argin technology, fluoride and a high cleaning calcium carbonate system, has now been clinically and scientifically validated. This toothpaste works by the same mechanism of action as its non-whitening counterpart and is clinically proven to provide both instant and lasting relief of sensitivity, while providing proven efficacy in removal of extrinsic stains. No difference in desensitizing efficacy was observed between the whitening and non-whitening versions.

Dentin hypersensitivity: from diagnosis to a breakthrough therapy for everyday sensitivity relief.

This paper provides an overview of the current knowledge of diagnosis, epidemiology, etiology, and clinical management of dentin hypersensitivity. It summarizes technical approaches to relieve sensitivity in professional and home-use products, with emphasis on the clinical evidence for the efficacy of desensitizing toothpaste, and introduces a new innovative dentifrice technology containing 8% arginine, calcium carbonate, and 1450 ppm fluoride. Dentin hypersensitivity is characterized by short, sharp pain arising from exposed dentin in response to external stimuli which cannot be ascribed to any other form of dental defect or disease. The hydrodynamic theory proposes that pain-producing stimuli cause a change in dentin fluid flow that activates intra-dental nerve fibers, via a mechanoreceptor response, to cause pain. To be hypersensitive, dentin must be exposed and dentin tubules must be open to external stimuli and patent at the pulp. Gingival recession is the primary cause of dentin exposure, and a major predisposing factor for dentin hypersensitivity. Dentin hypersensitivity is a prevalent condition. It has been reported to afflict 15-20% of the adult population, typically 20 to 50-year-olds, with peak incidence between 30 and 39 years. Some studies have reported higher prevalence levels of up to 57%. The incidence of dentin hypersensitivity is expected to rise with changing diets, and as caries and periodontal disease prevention result in improved oral health status, and retention and functionality of the dentition. Treatments to relieve dentin hypersensitivity are based on interruption of the neural response to pain stimuli or occlusion of open tubules to block the hydrodynamic mechanism. Effective and robust dentin occlusion offers the greatest prospect for instant and lasting relief of dentin hypersensitivity. In particular, materials which can coat exposed dentin surfaces, in addition to plugging and sealing open dentin tubules, offer the intriguing prospect of strengthening dentin and rendering it less susceptible to predisposing factors, while concurrently reducing dentin hypersensitivity. Clinical studies have shown that a new toothpaste containing 8% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate offers significantly increased efficacy in reducing sensitivity, compared to a market-leading toothpaste containing 2% potassium ion. Mechanism of action studies have shown that this technology physically seals dentin tubules with a plug that contains arginine, calcium carbonate, and phosphate. This plug, which is resistant to normal pulpal pressures and to acid challenge, effectively reduces dentin fluid flow and, thereby, reduces sensitivity.

Comparing the efficacy in reducing dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a commercial sensitive toothpaste containing 2% potassium ion: an eight-week clinical study on Canadian adults.

OBJECTIVE: This paper presents the results of one of two eight-week dentin hypersensitivity clinical studies in which the efficacy of a novel toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a benchmark commercial toothpaste containing 2% potassium ion, dosed as 3.75% potassium chloride, and 1450 ppm fluoride as sodium fluoride (NaF). METHODS: An eight-week clinical study, with seventy-seven patients, was conducted in Mississauga, Canada using a double-blind, stratified, two-treatment design. Tactile sensitivity assessments, as well as air blast sensitivity assessments, were used to compare the efficacy of the two products. RESULTS: This clinical study demonstrated that the new toothpaste, containing 8.0% arginine and 1450 ppm MFP in a calcium carbonate base, provided a significant reduction in dentin hypersensitivity when used over a period of eight weeks. The study also showed that this new arginine toothpaste provided significantly greater reductions (p < 0.05) in dentin hypersensitivity in response to tactile (16.2%, 22.4%, and 21.4%) and air blast (16.2%, 29.2%, and 63.4%) stimuli than the benchmark commercial toothpaste containing 2% potassium ion and 1450 ppm NaF in a silica base, after two, four, and eight weeks of product use, respectively. CONCLUSION: A new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride, as sodium monofluorophosphate (MFP), provides significantly greater hypersensitivity relief (p < 0.05) compared to a commercial sensitive toothpaste containing 2% potassium ion after two, four, and eight weeks of product use.

Comparing the efficacy in reducing dentin hypersensitivity of a new toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride to a commercial sensitive toothpaste containing 2% potassium ion: an eight-week clinical study in Rome, Italy.

OBJECTIVE: This paper presents the results of one of two eight-week dentin hypersensitivity clinical studies in which the efficacy of a novel toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a benchmark commercial toothpaste containing 2% potassium ion, dosed as 3.75% potassium chloride, and 1450 ppm fluoride as sodium fluoride (NaF). METHODS: An eight-week clinical study, with eighty patients, was conducted in Rome, Italy using a double-blind, stratified, two-treatment design. Tactile sensitivity assessments, as well as air blast sensitivity assessments, were used to compare the efficacy of the two products. RESULTS: This clinical study showed that the new toothpaste containing 8.0% arginine and 1450 ppm fluoride as MFP in a calcium carbonate base provided a significant reduction in dentin hypersensitivity when used over a period of eight weeks. The study also showed that this new arginine toothpaste provided significantly greater reductions (p < 0.05) in dentin hypersensitivity in response to tactile (37.0%, 30.0%, and 12.2%) and air blast (23.9%, 32.0%, and 29.3%) stimuli than the commercial sensitive toothpaste containing 2% potassium ion and 1450 ppm fluoride as NaF in a silica base, after two weeks, four weeks, and eight weeks of product use, respectively. CONCLUSION: A new toothpaste containing 8.0% arginine calcium carbonate, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) provides significantly increased dentin hypersensitivity relief (p < 0.05) compared to a commercial sensitive toothpaste containing 2% potassium ion after two weeks, four weeks, and eight weeks of product use.

A breakthrough therapy for dentin hypersensitivity: how dental products containing 8% arginine and calcium carbonate work to deliver effective relief of sensitive teeth.

OBJECTIVE: These studies have utilized a range of state-of-the-art surface techniques to gain insight into the mechanism of action of a new technology for dentin hypersensitivity relief based upon arginine and calcium carbonate and, in particular, to address important questions regarding the nature and extent of dentin tubule occlusion. METHODS: Confocal laser scanning microscopy (CLSM), scanning electron microscopy (SEM), and atomic force microscopy (AFM) have been used to assess tubule occlusion. Energy dispersive x-ray (EDX) and electron spectroscopy for chemical analysis (ESCA) have been used to identify the composition of the dentin plug. CLSM has also been used to compare the mechanism of action of the toothpaste and the desensitizing prophylaxis paste, to address whether both the arginine and the calcium carbonate components are essential to occlusion, to identify the location of the arginine within the occluded dentin, and to demonstrate resistance of the occlusion to acid challenge. Hydraulic conductance has been used to assess the effectiveness of the arginine-calcium carbonate technology in arresting dentin fluid movement, to evaluate the effects of pulpal pressure on the robustness of the occlusion, and to confirm the resistance of the occlusion to an acid challenge. RESULTS: The CLSM, SEM, and AFM studies demonstrate that the arginine-calcium carbonate technology is highly effective in rapidly and completely occluding dentin tubules. The EDX and ESCA studies show that the dentin surface deposit and occluded tubule plug contain high levels of calcium and phosphate, as well as carbonate. CLSM has confirmed that the toothpaste and the desensitizing prophylaxis paste have the same mechanism of action, that the arginine and calcium carbonate components are both essential to the effectiveness of these products, and that the arginine becomes incorporated into the dentin plug. The hydraulic conductance studies demonstrate that the occlusion provided by the arginine-calcium carbonate technology results in highly significant reductions in dentin fluid flow, and that the tubule plug is resistant to normal pulpal pressure and acid challenge. CONCLUSION: A breakthrough technology based upon arginine and calcium carbonate provides clinically proven benefits with respect to rapid and lasting relief of dentin hypersensitivity. It is unique in that two of its key components, arginine and calcium, are found naturally in saliva, and that the arginine and calcium carbonate work together to accelerate the natural mechanisms of occlusion to deposit a dentin-like mineral, containing calcium and phosphate, within the dentin tubules and in a protective layer on the dentin surface.

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

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

Comparing the effects of brushing with a new gel-to-foam dentifrice to brushing with regular fluoride control dentifrices on viable bacteria levels in saliva.

PURPOSE: To compare the effects of a new gel-to-foam dentifrice to two standard fluoride control dentifrices on foam generation, levels of total viable anaerobes and total viable volatile sulfur compound (VSC)-producing bacteria in expectorate after brushing. METHODS: 36 subjects participated in this investigator-blind, randomized, crossover study. After a 1-week wash-out period prior to each product use, participants reported to the test site having refrained from oral hygiene, eating and drinking on the morning prior to the visit. Subjects brushed with a full ribbon of assigned dentifrice (Aquafresh Iso-active, Aquafresh Extreme Clean or Aquafresh Fresh & Minty), then expectorated the slurry into a collection vessel after 30 and 60 seconds of supervised brushing. Total foam volume was immediately measured. Subjects then rinsed with sterile water for 10 seconds and expectorated into the same vessel, which was processed for microbiological analysis. Total viable anaerobes and total viable VSC-producing bacteria were enumerated using appropriate selective media. RESULTS: No statistically significant difference was indicated between the gel-to-foam dentifrice and either of the control dentifrices with respect to the level of total viable anaerobes (P > 0.05). The level of total viable VSC-producing bacteria was statistically significantly lower for the gel-to-foam dentifrice (Aquafresh Iso-active) than for one of the control dentifrices (Aquafresh Fresh & Minty) (P < 0.05), and numerically lower for the gel-to-foam dentifrice than for the other control dentifrice (Aquafresh Extreme Clean) (P = 0.0526). Use of the gel-to-foam dentifrice resulted in statistically significantly greater (P < 0.05) foam generation than the two control dentifrices.

Multiparameter assessments to determine the effects of sugars and antimicrobials on a polymicrobial oral biofilm.

Clinical studies indicate relationships between dental plaque, a naturally formed biofilm, and oral diseases. The crucial role of nonmicrobial biofilm constituents in maintaining biofilm structure and biofilm-specific attributes, such as resistance to shear and viscoelasticity, is increasingly recognized. Concurrent analyses of the diverse nonmicrobial biofilm components for multiparameter assessments formed the focus of this investigation. Comparable numbers of Actinomyces viscosus, Streptococcus sanguinis, Streptococcus mutans, Neisseria subflava, and Actinobacillus actinomycetemcomitans cells were seeded into multiple wells of 96-well polystyrene plates for biofilm formation. Quantitative fluorescence and confocal laser scanning microscopy (CLSM) examined the influences of dietary sugars, incubation conditions, ingredients in oral hygiene formulations, and antibiotics on biofilm components. Biofilm extracellular polymeric substances (EPS) were examined with an optimized mixture of fluorescent lectins, with biofilm proteins, lipids, and nucleic acids detected with specific fluorescent stains. Anaerobic incubation of biofilms resulted in significantly more biofilm EPS and extractable carbohydrates than those formed under aerobic conditions (P < 0.05). Sucrose significantly enhanced biofilm EPS in comparison to fructose, galactose, glucose, and lactose (P < 0.05). CLSM demonstrated thicker biofilms under sucrose-replete conditions, along with significant increases in biofilm EPS, proteins, lipids, and nucleic acids, than under conditions of sucrose deficiency (P < 0.05). Agents in oral hygiene formulations (chlorhexidine, ethanol, and sodium lauryl sulfate), a mucolytic agent (N-acetyl-L-cysteine), and antibiotics with different modes of action (amoxicillin, doxycycline, erythromycin, metronidazole, and vancomycin) inhibited biofilm components (P < 0.05). Multiparameter analysis indicated a dose-dependent inhibition of biofilm EPS and protein by chlorhexidine and sodium lauryl sulfate, along with distinctive inhibitory patterns for subinhibitory concentrations of antibiotics. Collectively, these results highlight multiparameter assessments as a broad platform for simultaneous assessment of diverse biofilm components.

The impact of research and development on the prevention of oral diseases in children and adolescents: an industry perspective.

Significant progress has been made globally in reducing dental caries and periodontal disease through adoption of safe and effective methods of prevention. Nonetheless, there are profound oral health disparities in the population and this necessitates further improvement. This review provides an industry perspective of the impact of research and development on the prevention of oral disease in children and adolescents. It also provides an overview and discussion of the key routes that are currently under investigation in academic research, together with an outline of what it will take to develop a major new therapeutic and bring it into clinical practice and individual self care. The key challenges and opportunities are summarized.

Analysis of the antibacterial activity and plaque control benefit of colgate total dentifrice via clinical evaluation and real-time polymerase chain reaction.

OBJECTIVE: This study analyzed, from a combined clinical and molecular biologic perspective, the antibacterial and antiplaque efficacy of Colgate Total dentifrice (CTD). METHODOLOGY: A single-blind crossover study design utilized 11 healthy human subjects. After a one-week washout period, subjects donated dental plaque, received a dental prophylaxis, and subsequently brushed with a test product. Twenty-four hours postbrushing, dental plaque was collected and a clinical plaque score determined. Dental plaque was submitted for Real-time Polymerase Chain Reaction (Real-time PCR) analysis. The same procedure was repeated in accordance with a crossover design for the use of the second test product. Following a one-week washout, a plaque donation, prophylaxis, and brushing with the test product ensued for each subject. Twenty-four hours post-brushing, the subjects returned for a plaque score and plaque donation. RESULTS: Twenty-four hours after brushing, dental plaque coverage increased 17.88% +/- 8.27% with CTD, compared to 30.42% +/- 9.97% with Colgate Cavity Protection (CCP; p = 0.005). Real-time PCR found plaque collected 24 hours after brushing with CTD exhibited, on average, fewer representative periodontal pathogens (Fusobacterium nucleatum, Actinobacillus actinomycetemcomitans, Tannerella forsythensis, and Porphyromonas gingivalis) and fewer early colonizers (Actinomyces naeslundii) than plaque collected before brushing, whereas CCP showed a moderate effect on oral bacteria. CONCLUSION: The study provides clinical and molecular biological evidence to substantiate the antibacterial and plaque control benefits of Colgate Total, and suggests the value of combining a molecular biological method with clinical research to corroborate clinical benefits.

Clinical efficacy of Colgate 360 degrees and three commercially available toothbrushes on the removal of desquamated epithelial cells.

A clinical study was done to evaluate the performance of four toothbrushes on the removal of desquamated epithelial cells after brushing according to the manufacturers' instructions for use. This randomized, crossover-design clinical study compared a new manual toothbrush (Colgate 360 degrees) to two commercially available manual toothbrushes (Oral-B CrossAction and Oral-B Indicator) and a commercially available battery-powered toothbrush (Crest SpinBrush PRO). Adult men and women subjects reported to the clinical facility after a 1-week "washout" period of brushing with a regular fluoride dentifrice and a soft-bristled toothbrush. Participants reported having refrained from oral hygiene procedures, eating, and drinking that morning. After providing a baseline rinse sample, subjects brushed their teeth for 1 minute with their assigned toothbrush and a commercially available fluoride toothpaste, then returned 30 minutes later to provide postuse rinse samples. Subjects refrained from dental hygiene, eating, and drinking during the 30-minute evaluation period. To provide the samples, subjects rinsed with 10 mL of sterile phosphate-buffered saline solution for 10 seconds. Each collected sample was centrifuged, resuspended, and run in a colorimetric assay to determine the level of desquamated epithelial cells found in the rinse as measured by the absorbance at 570 nm. Twenty adults completed the study. At baseline, the mean levels of desquamated epithelial cells for the 4 treatments were 0.70+/-0.27, 0.63+/-0.20, 0.69+/-0.30, and 0.62+/-0.31 for the Colgate 360 degrees, Oral-B Indicator, Crest SpinBrush PRO, and Oral-B CrossAction, respectively. Posttreatment, the mean levels of epithelial cells were 0.19, 0.38, 0.42, and 0.34, respectively. All of the treatments provided a statistically significant reduction compared to their respective baseline. In addition, the Colgate 360 degrees toothbrush was statistically significantly better than the other three toothbrushes in reducing desquamated epithelial cells. Therefore, the results of this randomized, crossover clinical study indicate that the newly designed Colgate 360 degrees manual toothbrush, with a tongue-cleaning implement on the back of the brush head, was statistically significantly more effective than the Oral-B Indicator, Crest SpinBrush PRO, and Oral-B CrossAction toothbrushes in removing desquamated epithelial cells.

Clinical comparison of a new manual toothbrush on the level of hydrogen-sulfide-forming bacteria on the tongue.

The objective of this randomized, crossover study was to compare the effectiveness of a newly designed manual toothbrush (Colgate 360 degrees) to two commercially available manual toothbrushes (Oral-B Indicator and Oral-B CrossAction) and a battery-powered toothbrush (Crest SpinBrush PRO) for their ability to reduce hydrogen-sulfide-forming bacteria on the tongue. After a washout period, subjects arrived at the clinical site for baseline sampling without performing dental hygiene, eating, or drinking. Subjects sampled the left side of their tongue with a cotton swab. Subjects brushed for 1 minute with the assigned test toothbrush and regular fluoride toothpaste. Those using the Colgate 360 degrees toothbrush were instructed to clean their tongue with the implement on the back of the brush head for 10 seconds. After 2 hours, the subjects returned to the clinical site having refrained from dental hygiene, eating, and drinking for posttreatment sampling, this time sampling the right side of their tongue. After a minimum 2-day washout period, subjects repeated the same regimen using the other toothbrushes. Collected tongue samples were dispersed in sterile water, serially diluted in sterile phosphate-buffered saline, and plated in duplicate onto lead acetate agar. When plated on this medium, bacteria that produce hydrogen sulfide appear as dark-pigmented colonies. After 72 hours of incubation, the dark colonies were counted, expressed as log colony-forming units/mL, and reduction from baseline was calculated. Thirty-one adult men and women completed the clinical study. There was no significant difference between baseline hydrogen-sulfide-forming bacteria levels. Posttreatment, the log reduction of bacteria was 0.80, 0.41, 0.33, and 0.44 for the Colgate 360 degrees, Oral-B Indicator, Crest SpinBrush PRO, and Oral-B CrossAction, respectively. Statistical analysis indicated that the Colgate 360 toothbrush was statistically significantly better (P < .05) than the 3 commercial toothbrushes in reducing the levels of hydrogen-sulfide-forming bacteria on the tongue.

Clinical comparison of a new manual toothbrush on breath volatile sulfur compounds.

The objective of this randomized, crossover study was to compare the effectiveness of a newly designed manual toothbrush (Colgate 360 degrees) to two commercially available manual toothbrushes (Oral-B Indicator and Oral-B CrossAction) and a battery-powered toothbrush (Crest SpinBrush PRO) for their ability to reduce overnight volatile sulfur compounds (VSC) associated with oral malodor. The study followed a four-period crossover design. Following a washout period, prospective subjects arrived at the testing facility without eating, drinking, or performing oral hygiene for baseline evaluation of breath VSC levels. For each phase of the study, subjects were given one of the test tooth-brushes and a tube of regular toothpaste to take home, and they were instructed to brush their teeth in their customary manner for 1 minute. When using the Colgate 360 degrees toothbrush, subjects were instructed to clean their tongue with the implement on the back of the brush head for 10 seconds. The following morning, subjects reported to the testing facility, again without performing oral hygiene, eating, or drinking, for the overnight evaluation. After a minimum 2-day washout period, subjects repeated the same regimen using the other toothbrushes. The levels of breath VSC were evaluated instrumentally using a gas chromatograph equipped with a flame photometric detector. Measurements were taken in duplicate and then averaged. The levels of VSC were expressed as parts per billion (ppb) in mouth air. Sixteen men and women completed the study. At baseline, the mean levels of VSC in mouth air for the 4 toothbrushes were 719.8 ppb+/-318.4 ppb, 592.8 ppb+/-264.6 ppb, 673.8 ppb+/-405.9 ppb, and 656.2 ppb+/-310.2 ppb for the Colgate 360 degrees, Oral-B Indicator, Crest SpinBrush PRO, and Oral-B CrossAction, respectively. Overnight, the mean breath VSC levels after using the four toothbrushes were lower than those observed at baseline. The respective mean levels of breath VSC were 266.5 ppb+/-269.9 ppb, 545.2 ppb+/-346.1 ppb, 567 ppb+/-335.7 ppb, and 554.6 ppb+/-398.4 ppb. Only the Colgate 360 degrees toothbrush provided a statistically significant reduction (P < .05) in breath VSC vs baseline. Additionally, the Colgate 360 degrees toothbrush was statistically significantly better (P < .05) than the three commercial toothbrushes in reducing breath VSC. Therefore, the results of this randomized, crossover clinical study indicate that a newly designed manual toothbrush with a tongue-cleaning implement on the back of the brush head was significantly more effective than three commercially available toothbrushes in reducing morning breath VSC associated with oral malodor.

Effectiveness of a triclosan/copolymer dentifrice on microbiological and inflammatory parameters.

According to the US Surgeon General's report, "Oral Health in America," published in 2000, most adults in the United States show some degree of periodontal pathology, with severe periodontal diseases affecting about 14% of middle-aged adults. Periodontal diseases are polymicrobial-induced inflammatory diseases, and they vary from mild gingival inflammation to severe deterioration of the periodontium, ie, loss of periodontal supportive tissues and, ultimately, tooth loss. New evidence shows that periodontal diseases may impact systemic health. For this reason, the maintenance of a healthy mouth is becoming increasingly important for the overall health of the body. This article summarizes laboratory research conducted during the development of a novel, multibenefit, oral-care technology based on triclosan--a broad-spectrum antibacterial agent--and a polyvinylmethylether/maleic acid copolymer. This unique combination of agents is found in Colgate Total, a clinically proven efficacious dentifrice for control of dental plaque and gingivitis. Data are presented that demonstrate the unique antibacterial properties of this dentifrice: (1) a broad-spectrum antimicrobial profile; (2) the long-lasting retention of triclosan on hydroxyapatite and epithelial cells; and (3) molecular evidence of antibacterial activity against specific pathogens in clinical dental plaque. In addition, data are presented that demonstrate the anti-inflammatory effects of triclosan on specific cytokines, the interruption of inflammatory pathways, and the inhibition of bone resorption. Overall, these data support the multibenefit clinical effects of Colgate Total and suggest a plurality of mechanisms of action.