AIM:This study tests the hypothesis that salivary extracellular RNA (exRNA) biomarkers can be developed for gingivitis detection and monitoring disease regression.MATERIALS AND METHODS:Salivary exRNA biomarker candidates were developed from a total of 100 gingivitis and non-gingivitis individuals using Affymetrix's expression microarrays. The top 10 differentially expressed exRNAs were tested in a clinical cohort to determine whether the discovered salivary exRNA markers for gingivitis were associated with clinical gingivitis and disease regression. For this purpose, unstimulated saliva was collected from 30 randomly selected gingivitis subjects, the gingival and plaque indexes scores were taken at baseline, 3 and 6 weeks and salivary exRNAs were assayed by means of reverse transcription quantitative polymerase chain reaction.RESULTS:Eight salivary exRNA biomarkers developed for gingivitis were statistically significantly changed over time, consistent with disease regression. A panel of four salivary exRNAs [SPRR1A, lnc-TET3-2:1, FAM25A, CRCT1] can detect gingivitis with a clinical performance of 0.91 area under the curve, with 71% sensitivity and 100% specificity.CONCLUSIONS:The clinical values of the developed salivary exRNA biomarkers are associated with gingivitis regression. They offer strong potential to be advanced for definitive validation and clinical laboratory development test.

the authors used an electrical caries monitor to objectively measure remineralization, an approach that the authors included as one of their a priori outcome measures. Where the reviewers have required additional data and clarification, for example with regard to randomization, the company has provided detailed information, but the reviewers have chosen to disregard it. Similarly, where other factual inaccuracies in the review have been pointed out, these too have not been addressed. For example, the statement that “there is no evidence as to whether arginine added to fluoride-containing dentifrices causes any complication and/or side effects” is incorrect. Rather, 3 of the 4 studies reviewed contained statements that no adverse events attributable to products were reported in the trials, and we have confirmed to the authors that there has never been a single adverse event attributable to the arginine product reported in any of the studies we have conducted. With regard to the use of the a nonfluoride toothpaste in 2 of the 3 quantified light-induced fluorescence 6-month studies, all students had supervised brushing in the schools, which would account for the fact that even the nonfluoride toothpaste participants showed a reduction in lesion size at the end of the study, as was acknowledged by the authors. Ethics were reviewed by the Institutional Review Board (Ethics Committee) of Sichuan University, home to one of China’s leading dental schools. It is this review board that is best qualified to judge the ethics of a research program in China. This review recognized the compelling reason to include a nonfluoride control group in the study in order to gather direct evidence of the efficacy of fluoride toothpaste in the Chinese setting and thereby increase acceptance of fluoride as the standard of care in China. It is somewhat inconsistent for the authors to infer that clinical trial results derived from an Asian population are not transferable to the Swedish population whilst the Chinese and other Asian communities should accept the evidence provided by studies on fluoride toothpastes predominantly conducted in the West. Colgate-Palmolive believes in robust criticism that is based on facts and conducted with the goal of improving research outcomes, but we do not believe that this review serves that goal. With a program that included 2 large clinical studies assessing caries at the cavitation level and 3 studies assessing the ability to remineralize enamel lesions, 2 to remineralize root caries lesions and a community-based intervention, our investigation of the arginine product is one of the largest caries clinical trial programs sponsored by industry. We have attempted to address caries prevention and treatment in a wide variety of populations using a wide range of methods and clinical trial designs. These were well-conducted, high-quality studies published in peer-reviewed journals and consistently showed a significant benefit for the addition of arginine to fluoride toothpaste. As all readers of the journal are aware, dental caries remains a significant health problem, and we believe this groundbreaking toothpaste could have a significant impact on the global burden of Dear Editor, The Colgate-Palmolive Company is extremely proud of the clinical program conducted on the addition of 1.5% arginine to fluoride toothpaste. This program to date consists of 9 clinical efficacy studies, published in four peer-reviewed journals including Caries Research . It was conducted in collaboration with leading dental universities around the world and involved more than 16,000 participants. These studies demonstrated that the arginine plus fluoride formula, compared to regular fluoride toothpaste, consistently reduced new cavities by up to 20% at 2 years [Kraivaphan, 2013; Li et al., 2015] and reversed early caries lesions by approximately half in 6 months [Yin et al., 2013a, b; Srisilapanan, 2013]. Furthermore, a community-based study conducted in Thailand demonstrated that when arginine plus fluoride toothpaste was incorporated into a well-conducted school-based oral health program, up to 40% reductions in dental decay could be demonstrated [Petersen et al., 2015]. We were therefore extremely disappointed to see a recent review [Ástvaldsdóttir et al., 2016] (the “review”) in the journal, which we believe to be both out of date and in some instances factually incorrect. The review was based on a literature search of the Cochrane database conducted in April 2014 (dated February 2014) and submitted to the journal on the January 28, 2016. The company has made the authors aware of highly relevant additional studies that were missing from the review. These studies were included in another systematic review of arginine-containing toothpaste [Li et al., 2015] published in November 2015 in the journal 2 months prior to submission of the current manuscript. It is the duty of authors of systematic reviews to ensure that data included are as up to date as possible, and the authors’ disappointing reliance on a search of the literature nearly 2 years prior to the submission of the review throws their conclusions into serious doubt. We disagree with the statement “techniques measuring the outcomes in the adult studies were not validated and were at higher risk of bias.” Root caries is an increasing problem in elders, and the method used to measure the hardness of lesions was a method of assessment widely used in clinical studies, including some of those reported in this journal. We provided research evidence on the validity of the methods used, which again the authors chose to disregard without rationale. In addition, one of the studies omitted by Published online: February 9, 2017

Recent studies suggest that periodontal disease and type 2 diabetes mellitus are bi-directionally associated. Identification of a molecular signature for periodontitis using unbiased metabolic profiling could allow identification of biomarkers to assist in the diagnosis and monitoring of both diabetes and periodontal disease. This cross-sectional study identified plasma and salivary metabolic products associated with periodontitis and/or diabetes in order to discover biomarkers that may differentiate or demonstrate an interaction of these diseases. Saliva and plasma samples were analyzed from 161 diabetic and non-diabetic human subjects with a healthy periodontium, gingivitis and periodontitis. Metabolite profiling was performed using Metabolon's platform technology. A total of 772 metabolites were found in plasma and 475 in saliva. Diabetics had significantly higher levels of glucose and α-hydroxybutyrate, the established markers of diabetes, for all periodontal groups of subjects. Comparison of healthy, gingivitis and periodontitis saliva samples within the non-diabetic group confirmed findings from previous studies that included increased levels of markers of cellular energetic stress, increased purine degradation and glutathione metabolism through increased levels of oxidized glutathione and cysteine-glutathione disulfide, markers of oxidative stress, including increased purine degradation metabolites (e.g. guanosine and inosine), increased amino acid levels suggesting protein degradation, and increased ω-3 (docosapentaenoate) and ω-6 fatty acid (linoleate and arachidonate) signatures. Differences in saliva between diabetic and non-diabetic cohorts showed altered signatures of carbohydrate, lipid and oxidative stress exist in the diabetic samples. Global untargeted metabolic profiling of human saliva in diabetics replicated the metabolite signature of periodontal disease progression in non-diabetic patients and revealed unique metabolic signatures associated with periodontal disease in diabetics. The metabolites identified in this study that discriminated the periodontal groups may be useful for developing diagnostics and therapeutics tailored to the diabetic population.

OBJECTIVE:Evaluate the efficacy of 0.8% arginine, potassium nitrate and sodium fluoride mouthwashes on dentine hypersensitivity reduction.METHODS:Six week randomized, double blinded, two cell, parallel single centre clinical study in the Dominican Republic; subjects were randomized into three treatment groups: mouthwash containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride in an alcohol-free base (arginine); mouthwash containing 2.4% potassium nitrate and 0.022% sodium fluoride (potassium nitrate); a control mouthwash containing 0.05% sodium fluoride (negative control). Tactile and air-blast dentine hypersensitivity assessments were conducted at baseline, thirty minutes post rinsing and two, four, and six weeks of twice-daily product use. For treatment group comparisons, ANCOVA and post hoc Tukey's pair-wise comparisons (α=0.05) were done.RESULTS:Seventy-five subjects were enrolled; 69 subjects completed the study. There were no differences after thirty minutes of a single use, among the three groups with respect to mean tactile and air blast hypersensitivity scores compared to potassium nitrate and negative control mouthwashes (p<0.05). The arginine group presented a statistically significant improvement in the mean tactile scores compared to potassium nitrate and negative control groups after two, four, and six weeks (p<0.001) of product use; the arginine group showed a statistically significant enhancement in air blast hypersensitivity mean scores compared to potassium nitrate and negative control groups after two (p=0.001), four (p<0.001), and six weeks (p<0.001) of product use.CONCLUSION:A mouthwash containing arginine provides a significant and superior reduction in dentine hypersensitivity compared to potassium nitrate and a negative control mouthwash after two weeks.

ObjectiveThe 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”).MethodsQualifying subjects who presented two hypersensitive teeth with a tactile hypersensitivity score between 10 and 50g 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 20mL of their assigned mouthwash for 30s twice daily. Subjects refrained from eating or drinking for 30min 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.ResultsNinety (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.ConclusionThe 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.

Aim: Oral malodor (halitosis) is a widespread condition caused by oral bacteria, particularly sulfur compound-producing species.This study assessed the effect of a triclosan/copolymer-containing dentifrice and a novel toothbrush with attached tongue cleaner on oral malodor and on the bacteria colonizing the dorsal surface of the tongue.Materials and Methods: 14 adult subjects with oral malodor defined as organoleptic scores ≥ 3 (scale 0 -5) and mouth air sulfur levels ≥ 250 ppb participated in this study.Subjects were examined at baseline and after 28 days use of the triclosan dentifrice and toothbrush/tongue cleaner for: 1) organoleptic assessment; 2) mouth air sulfur levels; 3) tongue coating; and, 4) dorsal tongue surface microorganisms.Total bacterial numbers were assayed by microscopy.Dot-blot hybridization was used to assess a panel of 20 oral bacteria.Results: After 28 days, all subjects had significantly reduced organoleptic scores and mouth air sulfur levels compared to baseline (p < 0.0001).There was >70% reduction in microbial numbers (p < 0.001) on the dorsal tongue and significant reductions in Enterococcus faecalis (p < 0.003), Neisseria sp.(p < 0.008), Peptostreptococcus micros (p < 0.0007), Prevotella melaninogenica (p < 0.02), Porphyromonas gingivalis (p < 0.0001), Solobacterium moorei (p < 0.04), and Streptococci sp.(p < 0.03).Conclusions: Oral malodor was successfully treated in all subjects following 28 days use of the triclosan/copolymer-containing dentifrice and toothbrush with a tongue cleaner as determined by significant reductions in clinical measures of halitosis and a corresponding reduction in microbiological measures including sulfur compound-producing oral bacteria.

A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base. The 6,000 participants were from Bangkok, Thailand and aged 6-12 years initially. They were instructed to brush twice daily, in the morning and evening, with their randomly assigned dentifrice. Three trained and calibrated dentists examined the children at baseline and after 1 and 2 years using the National Institute of Dental Research Diagnostic Procedures and Criteria. The number of decayed, missing and filled teeth (DMFT) and surfaces (DMFS) for the three study groups were very similar at baseline, with no statistically significant differences among groups. After 1 year, there were no statistically significant differences in caries increments among the three groups. After 2 years, the two groups using the dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F had statistically significantly (p < 0.02) lower DMFT increments (21.0 and 17.7% reductions, respectively) and DMFS increments (16.5 and 16.5%) compared to the control dentifrice. The differences between the two groups using the new dentifrices were not statistically significant. The results of this pivotal clinical study support the conclusion that dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm F provide significantly greater protection against caries lesion cavitation, in a low to moderate caries risk population, than dentifrices containing 1,450 ppm F alone.

Objectives To study the effectiveness of a dentifrice containing polyvinylmethyl ether-maleic acid (PVM/MA) copolymer in occluding dentin tubules and investigate the interaction between PVM/MA and type I collagen using surface plasmon resonance (SPR). Materials and methods Fifteen volunteers brushed dentin discs in situ using dentifrices with and without PVM/MA copolymer in a cross-over design. Dentin tubule occlusion was evaluated after brushing, after overnight saliva challenge in vivo for 12 h and after drinking 250 ml of orange juice. Dentin tubule occlusion and tubule size were compared between the two groups using repeated ANOVA and before and after erosive challenges using paired t tests. SPR using type I collagen as ligand and PVM/MA as analyte was performed to evaluate the binding of the two macromolecules. Results A median of 91 % of dentin tubules were occluded after a single brushing in the PVM/MA group, as compared to 9 % in the controls. After overnight saliva challenge and 10 min of erosion by orange juice, a median of 73 % of the dentin tubules remained fully occluded in the PVM/MA group as compared to zero in the controls. Dentin tubule size increased after orange juice erosion in the controls but not in the PVM/MA group. SPR study showed that PVM/MA bound readily to collagen molecules in a 4 to 1 ratio. Conclusions Dentifrice containing PVM/MA could effectively occlude dentin tubules and prevent dentin erosion. PVM/MA may improve adhesive retention of intra-tubular dentifrice plugs through binding to dentin surface collagen. Clinical relevance Brushing with dentifrice containing adhesive polymers has preventive effect against dentin erosion and dentin sensitivity.

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.

Objective: Evaluate the efficacy of 0.8% arginine, potassium nitrate and sodium fluoride mouthwashes on dentine hypersensitivity reduction. Methods: Six week randomized, double blinded, two cell, parallel single centre clinical study in the Dominican Republic; subjects were randomized into three treatment groups: mouthwash containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride in an alcohol-free base (arginine); mouthwash containing 2.4% potassium nitrate and 0.022% sodium fluoride (potassium nitrate); a control mouthwash containing 0.05% sodium fluoride (negative control). Tactile and air-blast dentine hypersensitivity assessments were conducted at baseline, thirty minutes post rinsing and two, four, and six weeks of twice-daily product use. For treatment group comparisons, ANCOVA and post hoc Tukey’s pair-wise comparisons (a = 0.05) were done. Results: Seventy-five subjects were enrolled; 69 subjects completed the study. There were no differences after thirty minutes of a single use, among the three groups with respect to mean tactile and air blast hypersensitivity scores compared to potassium nitrate and negative control mouthwashes ( p < 0.05). The arginine group presented a statistically significant improvement in the mean tactile scores compared to potassium nitrate and negative control groups after two, four, and six weeks ( p < 0.001) of product use; the arginine group showed a statistically significant enhancement in air blast hypersensitivity mean scores compared to potassium nitrate and negative control groups after two ( p = 0.001), four ( p < 0.001), and six weeks ( p < 0.001) of product use. * Corresponding author at: 1928 Calle Orquidea, Santa Marı́a, San Juan 00927, Puerto Rico. Tel.: +787 758 3919. Available online at www.sciencedirect.com journal homepage: www.intl.elsevierhealth.com/journals/jden E-mail address: augusto.elias@upr.edu (A. R. Elı́as Boneta). 0300-5712/$ – see front matter # 2012 Elsevier Ltd. All rights reserved. http://dx.doi.org/10.1016/j.jdent.2012.11.004 Conclusion: A mouthwash containing arginine provides a significant and superior reduction in dentine hypersensitivity compared to potassium nitrate and a negative control mouthwash

Objective: Evaluate the efficacy of three regimens integrating toothpaste, toothbrush and mouthwash in reducing dentine hypersensitivity.Methods: Eight-week single-centre, three-cell, double-blind, randomized study was conducted in the Dominican Republic. Subjects entered one of the three regimens: (1) toothpaste containing 8% arginine and 1450 ppm mono-fluorophosphate, in a calcium carbonate base, a soft-bristle toothbrush followed by a mouthwash containing 0.8% arginine, PVM/MA copolymer, pyrophosphates, and 0.05% sodium fluoride; (2) toothpaste containing 5% potassium nitrate and 1450 ppm sodium fluoride, a soft-bristle toothbrush, followed by a mouthwash containing 0.51% potassium chloride and 230 ppm sodium fluoride; and (3) toothpaste containing 1450 ppm mono-fluorophosphate, a soft-bristle toothbrush followed by a fluoride/arginine free mouthwash. Tactile and Air-Blast dentine hypersensitivity measurements were performed at baseline, two, four, and eight weeks. For treatment group comparisons, ANCOVA and post hoc Tukey's pair-wise (alpha = 0.05) were used. Kaplan-Meier survival analysis was performed to evaluate Time to Treatment Improvement.Results: 120 subjects were enrolled, 118 completed the study. The Tactile hypersensitivity mean scores showed statistically significant improvement at two, four and eight (p <= 0.001) weeks in the arginine regime; the potassium regime did not show significant (p >= 0.05) improvement. Air-Blast Hypersensitivity scores had a statistically significant decrease at two (p = 0.006), four (p = 0.006) and eight (p = 0.002) weeks in arginine and potassium regimes (p <= 0.05). The most effective treatment proved to be arginine (p <= 0.05) compared to the potassium regime.Conclusion: Arginine regimen provided the greatest reduction in Tactile and Air-Blast dentine hypersensitivity compared to potassium and negative control regimens; and provides faster dentine hypersensitivity relief than potassium regimen. (C) 2013 Published by Elsevier Ltd.

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.

OBJECTIVE:This clinical study evaluated relief from dentin hypersensitivity among subjects who brushed their teeth with a new dentifrice containing 8.0% arginine, calcium carbonate, and 1000 ppm fluoride as sodium monofluorophosphate (MFP) to subjects who brushed with a commercially available dentifrice containing 1000 ppm MFP over an eight-week period.METHODS:Adult subjects from the New Delhi, India area, with two teeth that exhibited dentin hypersensitivity, both to tactile stimulation using the Yeaple Probe and to stimulation using an air blast delivered by a standard dental unit syringe, were screened for study enrollment. Qualifying subjects were randomly assigned one of the study dentifrices and instructed to brush their teeth for one minute, twice daily (morning and evening) with the provided dentifrice. Follow-up examinations for dentin hypersensitivity were conducted after two, four, and eight weeks of product use.RESULTS:Subjects provided with the new dentifrice containing 8.0% arginine, calcium carbonate, and 1000 ppm MFP exhibited statistically significantly (p < 0.05) greater reductions in dentin hypersensitivity in response to tactile (81.9%, 90.5%, and 116.7%) and air blast (39.5%, 56.7%, and 76.7%) stimuli than subjects assigned the 1000 ppm MFP dentifrice after two, four, and eight weeks, respectively.CONCLUSION:The use of a new dentifrice containing 8.0% arginine, calcium carbonate, and 1000 ppm MFP provides superior efficacy in reducing dentin hypersensitivity (p < 0.05) than a control dentifrice containing 1000 ppm MFP alone after two, four, and eight weeks of use.

OBJECTIVE:This clinical study was designed to compare dentin hypersensitivity relief among subjects who brushed their teeth with a new toothpaste containing 8.0% arginine, calcium carbonate, and 1000 ppm fluoride as sodium monofluorophosphate (MFP) to subjects who brushed with a commercially available dentifrice containing 2% potassium ion as potassium nitrate over an eight-week period.METHODS:Adult male and female subjects from the New Delhi, India area were required to present two teeth that exhibited dentin hypersensitivity, both to tactile stimulation using the Yeaple Probe and to air blast stimulation delivered by a standard dental unit syringe. After an examination of the oral soft and hard tissues, qualifying subjects were randomly assigned one of the study dentifrices and a soft-bristled toothbrush, and were instructed to brush their teeth for one minute, twice daily (morning and evening), using only the toothbrush and dentifrice provided. No other oral hygiene practices were permitted over the course of the study. After two, four, and eight weeks of product use, subjects returned to the dental clinic for follow-up examinations of tactile and air blast sensitivity of the baseline-designated hypersensitive teeth. Examinations of the oral soft and hard tissues were also performed at these follow-up visits.RESULTS:Subjects who brushed with the new dentifrice containing 8.0% arginine, calcium carbonate, and 1000 ppm MFP exhibited statistically significant reductions (p < 0.05) in dentin hypersensitivity in response to tactile (36.2%, 33.1%, and 29.7%) and air blast (16.4%, 31.1%, 58.8%) stimuli when compared to the subjects who brushed with the 2% potassium ion as potassium nitrate dentifrice after two, four, and eight weeks, respectively.CONCLUSION:The use ofa new dentifrice containing 8.0% arginine, calcium carbonate, and 1000 ppm MFP provides greater efficacy in reducing dentin hypersensitivity when compared to a dentifrice containing 2% potassium ion, as potassium nitrate, after two, four, and eight weeks of product use.

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.

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