Salivary exRNA biomarkers to detect gingivitis and monitor disease regression.

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.

Dentin tubule occlusion and erosion protection effects of dentifrice containing bioadhesive PVM/MA copolymers.

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.

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.

Comparative investigation of a dentifrice containing triclosan/copolymer/sodium fluoride and specially-designed silica and a dentifrice containing 0.243% sodium fluoride in a silica base for the control of established supra-gingival plaque and gingivitis: a 6-month clinical study.

PURPOSE: To investigate the efficacy of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica in controlling established dental plaque and gingivitis. METHODS: Qualifying adult male and female subjects from the West Palm Beach, Florida area were randomly assigned into one of two treatment groups: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride, and specially-designed silica (Test Dentifrice); and (2) a dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). All subjects received an oral soft and hard tissue examination, baseline plaque and gingivitis were assessed, and subjects were dispensed their assigned dentifrice product along with a soft-bristled adult toothbrush for home use. Subjects were instructed to brush their teeth for 1 minute, twice daily (morning and evening), using only the dentifrice provided. Examinations for plaque and gingivitis, and oral soft and hard tissue assessments were repeated after 3 and 6 months of product use. RESULTS: 115 subjects complied with the protocol, and completed the 6-month examination. After 6 months of product use, subjects assigned to the Test Dentifrice group exhibited statistically significant reductions from baseline with respect to Plaque Index, Plaque Severity Index, Gingival Index, and Gingivitis Severity Index scores; and subjects assigned to the Negative Control Dentifrice group exhibited statistically significant reductions from baseline with respect to Gingival Index scores only. Relative to the Negative Control Dentifrice group, the Test Dentifrice group exhibited an 18.8% reduction in Plaque Index; a 50% reduction in Plaque Severity Index; a 19.6% reduction in Gingival Index; and a 60% reduction in Gingivitis Severity Index after 6 months, all of which were statistically significant.

Assessment of hypersensitivity reduction of a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% NaF and specially-designed silica as compared to a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate and zinc lactate and to a dentifrice containing 0.243% NaF on dentin hypersensitivity reduction: an 8-week study.

PURPOSE: To evaluate the 8-week dentin hypersensitivity efficacy of three toothpastes: (1) a dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% sodium fluoride and specially-designed silica (Test Dentifrice 1); (2) a commercially-available dentifrice containing 0.454% stannous fluoride in a silica base with sodium hexametaphosphate and zinc lactate (Test Dentifrice 2); and (3) a commercially-available non-sensitive dentifrice containing 0.243% sodium fluoride in a silica base (Negative Control Dentifrice). METHODS: For this 8-week randomized controlled clinical study, qualifying subjects had to have at least two hypersensitive teeth with a tactile hypersensitivity score (Yeaple Probe) between 10 and 50 grams of force, and air blast hypersensitivity score of 2 or 3 (Schiff Cold Air Sensitivity Scale). Subjects brushed twice daily for 1 minute, using the assigned toothpaste and toothbrush. Dentin hypersensitivity assessments, as well as examinations of oral hard and soft tissues, were conducted at the baseline examination and after 4 and 8 weeks of brushing. RESULTS: 118 subjects complied with the protocol, and completed the 8-week study. At baseline, the mean tactile sensitivity scores for toothpastes (1), (2) and (3) were 13.6, 14.1 and 13.1; at 4 weeks 28.75, 20.13, and 20.00; and after 8 weeks 33.1, 24.0 and 20.5, respectively. The mean air blast scores for toothpastes (1), (2), and (3) at baseline were 2.5, 2.5, and 2.4; at 4 weeks 1.25, 1.50 and 1.85; and after 8 weeks 0.99, 1.36 and 1.5, respectively. At all time points after the baseline examination, for both tactile and air blast sensitivity scores, the differences between Test Dentifrice 1 and the Negative Control Dentifrice were statistically significant (P < 0.05). The differences between Test Dentifrice 1 and Test Dentifrice 2 were statistically significant (P < 0.05) at 4 and 8 weeks after baseline examination for tactile sensitivity scores and at 8 weeks after baseline examination for air blast sensitivity scores.

Extrinsic stain removal efficacy of a new dentifrice containing 0.3% triclosan, 2.0% PVM/MA copolymer, 0.243% NaF and specially-designed silica for sensitivity relief and whitening benefits as compared to a dentifrice containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF and to a negative control dentifrice containing 0.243% NaF: a 6-week study.

PURPOSE: This single-center, double-blind, randomized, parallel-group clinical study was designed to investigate the extrinsic stain removal efficacy of a new antisensitivity dentifrice containing 0.3% triclosan, 2% polyvinylmethyl ether/maleic acid copolymer (PVM/MA copolymer), 0.243% NaF and a new silica specially-designed to occlude dentin tubules, relative to a Positive Control dentifrice and a Negative Control dentifrice. METHODS: 117 qualifying adults were stratified by baseline Lobene Stain Index scores and randomly assigned to brush twice daily using a soft-bristled toothbrush and one of three dentifrices: (1) the Test Dentifrice; (2) a previously clinically proven dentifrice variant containing 0.3% triclosan, 2% PVM/MA copolymer, 0.243% NaF in a high cleaning silica base (Positive Control); and (3) a dentifrice containing 0.243% NaF in a silica base (Negative Control). Extrinsic stain area and stain intensity examinations were repeated after 3 and 6 weeks of product use. RESULTS: Relative to the Negative Control group, the Test group and the Positive Control group exhibited statistically significant improvements in mean Lobene composite stain scores after 3 weeks of product use (39.8% and 40.7% respectively) and after 6 weeks of product use (58.8% and 61.8% respectively). There were no statistically significant differences observed between the stain removal performance of the Test Dentifrice and the Positive Control Dentifrice after 3 and 6 weeks of product use.

Evaluation of the antiplaque efficacy of two cetylpyridinium chloride-containing mouthwashes.

OBJECTIVE: The purpose of this clinical study was to evaluate the efficacy in reducing dental plaque regrowth of two mouthwashes containing 0.075% cetylpyridinium chloride (CPC), one with 6% alcohol and one alcohol-free, as compared to a negative control mouthwash without CPC, using the Modified Gingival Margin Plaque Index (MGMPI). METHODS: The study was a double-blind, randomized, three-way crossover, controlled design. Following a washout period, subjects reported to the dental clinic where they were instructed to brush their teeth, used their assigned mouthwash, and were scored by the examining dentist for plaque using the MGMPI method. Subjects were instructed to refrain from all oral hygiene for the next 24 hours, except for rinsing with their assigned mouthwash 12 hours post-brushing. After this 24-hour period, subjects returned to the dental clinic and were once again scored for plaque. This sequence of washout followed by mouthwash use and plaque scoring was repeated until each subject had used all three mouthwashes. An ANOVA was conducted to assess between-group differences. RESULTS: The two test mouthwashes significantly reduced plaque regrowth over a 24-hour period (p < 0.05) as compared to the negative control mouthwash. The difference between the CPC-containing mouthwashes was not significant (p = 0.4868). CONCLUSION: Two mouthwashes containing 0.075% CPC, one with 6% alcohol and the other alcohol-free, were found to be safe and effective in reducing plaque accumulation when compared a negative control mouthwash without CPC. In short-term studies, the MGMPI appears useful for evaluating the antiplaque efficacy of mouthwash products.

Comparison of clinical efficacy of three toothpastes in reducing dentin hypersensitivity.

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.

Comparative evaluation of the efficacy of three commercially available toothpastes on dentin hypersensitivity reduction: an eight-week clinical study.

OBJECTIVE: The objective of this eight-week, single-center, three-cell, double-blind, and randomized clinical study was to evaluate the dentin hypersensitivity reduction efficacy of three commercially available toothpastes: 1) Colgate Sensitive Pro-Relief Toothpaste (also marketed as elmex Sensitive Professional); 2) Sensodyne Rapid Relief Toothpaste; and (3) Crest Cavity Protection Toothpaste. METHODS: 150 subjects, having two teeth with tactile and air blast hypersensitivity, were assigned to one of the three study groups (50/group). Subjects were then asked to brush their teeth for one minute, twice daily, with the given toothpaste. The dentin hypersensitivity and oral tissues were evaluated at baseline, two weeks, four weeks, and eight weeks. Comparison of the treatment groups with respect to gender was conducted using a chi-square analysis, and with respect to age and baseline hypersensitivity scores was 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 examine between-treatment effects. The post hoc Tukey test was performed for pair-wise comparisons. All statistical tests were two-sided using a significance level of alpha = 0.05. RESULTS: After two, four, and eight weeks of daily use of the products, all three groups showed a statistically significant reduction from baseline in tactile and air blast dentin hypersensitivity (p < 0.05). Colgate Sensitive Pro-Relief toothpaste produced a significant improvement in mean tactile and air blast dentin hypersensitivity scores, and was more effective than Sensodyne Rapid Relief toothpaste and Crest Cavity Protection toothpastes (p < 0.05). CONCLUSION: Colgate Sensitive Pro-ReliefToothpaste, used twice daily, significantly reduces dentin hypersensitivity, and is significantly more effective in reducing dentin hypersensitivity than Sensodyne Rapid Relief Toothpaste and Crest Cavity Protection Toothpaste.

Triclosan inhibition of acute and chronic inflammatory gene pathways.

AIM: We sought to determine whether triclosan (2,4,4'-trichloro-2'-hydroxydiphenylether), an extensively used anti-plaque agent with broad-spectrum anti-microbial activity, with reported anti-inflammatory effects via inhibition of prostaglandin E2 and interleukin 1 (IL-1)beta, could also more broadly suppress multiple inflammatory gene pathways responsible for the pathogenesis of gingivitis and periodontitis. MATERIALS AND METHODS: As an exploratory study, the effects of triclosan on the inflammatory gene expression profile were assessed ex vivo using peripheral whole blood samples from eight periodontally healthy donors. Ten-millilitres whole blood aliquots were incubated 2 h with 0.3 microg/ml Escherichia coli lipopolysaccharide (LPS) with or without 0.5 microg/ml triclosan. Affymetrix microarray gene expression profiles from isolated leucocytes and pathway-specific quantitative polymerase chain reaction arrays were used to investigate changes in expression of target cytokines and cell signalling molecules. RESULTS: Ex vivo human whole blood assays indicated that triclosan significantly down-regulated the LPS-stimulated expression of Toll-like receptor signalling molecules and other multiple inflammatory molecules including IL-1 and IL-6 and the dampening of signals that activate the T-helper type 1 acquired immune response via suppression of CD70 with concomitant up-regulation of growth factors related to bone morphogenetic protein (BMP)2 and BMP6 synthesis. CONCLUSIONS: Anti-inflammatory effects were found in this exploratory survey, including suppression of microbial-pathogen recognition pathway molecules and the suppression of acute and chronic mediators of inflammation.

Instant dentin hypersensitivity relief of a new desensitizing dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride: a 3-day clinical study in Chengdu, China.

PURPOSE: To compare, with a double-blind, randomized, parallel-design clinical study, the hypersensitivity efficacy of a new Pro-Argin formula dentifrice containing 8.0% arginine, a high cleaning calcium carbonate system and 1450 ppm fluoride to a previously validated Pro-Argin formula dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride, and to a control toothpaste containing calcium carbonate and 1450 ppm fluoride, instantly after a single direct topical self-application using a fingertip, and after subsequent brushing for 3 days. METHODS: Qualifying subjects from the Chengdu, China area who presented two hypersensitive teeth with a tactile score of 10 to 50 grams, and an air blast score of 2 or 3, participated in this study. The first phase of the study consisted of a single topical application of the assigned product directly onto the hypersensitive surface of each of the two hypersensitive teeth. Study subjects applied a pea-size amount of their toothpaste onto the hypersensitive surface and massaged for 1 minute. The second phase of the study consisted of twice-daily at-home brushing with the toothpaste for 3 days. RESULTS: All one hundred and twenty-two (122) subjects complied with the study protocol and completed the study. There was good balance among the three groups at baseline. The mean tactile sensitivity scores for the new Pro-Argin formula dentifrice, the previously validated Pro-Argin formula dentifrice, and the control dentifrice were at baseline 14.88, 14.76 and 14.38, and after direct application were 28.90, 29.02 and 15.88, and after 3 days of brushing were 34.51, 33.41 and 16.00, respectively. The mean air blast scores at baseline were 2.11, 2.12 and 2.15, and after direct application were 1.21, 1.18 and 2.06, and after 3 days of brushing were 0.80, 0.83 and 1.93, respectively. Immediately after direct application and after 3 days of brushing, for both the tactile and air blast sensitivity scores, the differences between the two dentifrices containing 8.0% arginine and the control were statistically significant. There were no statistically significant differences between the two 8.0% arginine dentifrices immediately after direct application and after 3 days of brushing.

Dentin hypersensitivity reduction of a new toothpaste containing 8.0% arginine and 1450 ppm fluoride: an 8-week clinical study on Chinese adults.

PURPOSE: To present the results of an 8-week dentin hypersensitivity clinical study in which the efficacy of a new Pro-Argin formula toothpaste, with gentle whitening benefits, containing 8.0% arginine, a high cleaning calcium carbonate system, and 1450 ppm fluoride as sodium monofluorophosphate (MFP) was compared to that of a commercial Pro-Argin formula toothpaste containing 8.0% arginine, calcium carbonate, and 1450 ppm fluoride as MFP and a negative control toothpaste containing calcium carbonate and 1450 ppm fluoride as MFP. METHODS: An 8-week clinical study, with 121 subjects, was conducted in Chengdu, Sichuan, China, using a double-blind, stratified, three-treatment design. Tactile and air blast sensitivity assessments were used to compare the efficacy of the three products. RESULTS: This clinical study demonstrated that the new Pro-Argin formula toothpaste provided a significant reduction in dentin hypersensitivity when used over a period of 8 weeks. The study also showed that the new toothpaste provided significantly greater reductions (P < 0.05) in dentin hypersensitivity in response to tactile (64.4%, 71.1%, and 61.0%) and air blast (40.7%, 58.8%, and 74.4%) stimuli than the negative control toothpaste containing 1450 ppm fluoride after 2, 4, and 8 weeks of product use, respectively. The results for the new toothpaste did not differ significantly from those of the positive control toothpaste at all time points in the study.

Extrinsic stain removal efficacy of a new desensitizing dentifrice containing 8.0% arginine, calcium carbonate and 1450 ppm fluoride.

PURPOSE: To evaluate the extrinsic stain removal efficacy of a new Pro-Argin formula whitening dentifrice containing 8.0% arginine, a high cleaning calcium carbonate and 1450 ppm fluoride, as monofluorophosphate, after brushing twice daily for 4 and 8 weeks. METHODS: At the baseline visit, 92 adult subjects were stratified based on their Lobene Stain Index scores and randomized into two treatment groups; one using the new Pro-Argin formula whitening dentifrice (test group) and the other using the original Pro-Argin formula dentifrice (control group). Subjects were instructed to brush twice daily for the duration of the study. Tooth stain evaluations were conducted as stain area and stain intensity according to the Lobene Stain Index. RESULTS: All 92 enrolled subjects complied with the protocol and completed the 8-week study. Baseline scores demonstrated no significant differences between the two treatment groups for the evaluated area and intensity parameters of stain (P > 0.05). At both the 4- and 8-week post-use evaluations, subjects brushing with the test dentifrice demonstrated significant reductions for all stain parameters versus the control (P < 0.05). Relative to the control group, the test group demonstrated reductions in mean stain intensity scores of 9.7% and 17.9% at the 4- and 8-week evaluations, respectively. Corresponding reductions in mean stain area scores for the test group relative to the control were 11.7% and 20.8% at the 4- and 8-week evaluations, respectively. (Am JDent 2010;23 Sp Is A:36A-40A).

Prevalence and severity of gingivitis in American adults.

PURPOSE: To investigate prevalence and severity of gingivitis in representative American adults. METHODS: Subjects (1,000) in Loma Linda, California; Seattle, Washington; and Boston, Massachusetts were examined for Löe-Silness Gingivitis Index (GI). Mann-Whitney rank sum test was used to determine significances in the GI between genders. The data among study sites and races were compared using the Kruskal-Wallis one-way ANOVA on ranks. The correlation of the GI and age was examined by the Spearman rank order correlation. Age differences among three sites were analyzed using the one-way ANOVA. RESULTS: The race composition of the subjects (mean age 37.9) approximated to the 2004 U.S. Census data. The overall average GI was 1.055. Only 6.1% of subjects showed mean GI<0.50; most (93.9%) were > or = 0.50, with 55.7% > or = 1.00. There was a significant correlation (P<0.001) between the age and GI. The males' GI was significantly higher (P<0.001) than the females'; African-Americans showed a significantly higher GI (P<0.05) than other races except for the Native-Americans.

Comparison of the short-term antiplaque/antibacterial efficacy of two commercial dentifrices.

OBJECTIVE: The objective of these three clinical trials was to compare the impact of two commercial products, Colgate Total and Crest Pro-Health, on the formation of dental plaque over a 24-hour period of time. The studies utilized the Modified Gingival Margin Plaque Index (MGMPI), a validated and reliable clinical method for assessing the efficacy of products in reducing plaque build-up. METHODS: Colgate Total and Crest Pro-Health were the test products for all three clinical trials. Colgate Great Regular Flavor (CR) was used as the universal washout product. Colgate Total, as the only toothpaste approved by the FDA under an NDA for antiplaque, antigingivitis, and anticaries benefits, contains 0.3% triclosan/2.0% PVM/MA copolymer for antigingivitis and antiplaque, as well as 0.243% sodium fluoride (NaF) for anticaries. Crest Pro-Health contains 0.454% stannous fluoride (SnF2) as both a monographed anticaries agent and a monographed antigingivitis agent, along with sodium hexametaphosphate and zinc lactate. Twenty-five healthy subjects meeting all study criteria were included into each of the double-blind studies. Product assignment was randomized and a crossover design was implemented. Informed consent was obtained from all subjects prior to commencement of each of the studies. The studies followed published MGMPI procedures, which require subjects to receive a dental scaling/prophylaxis followed by a one-week washout period prior to use of test products. A baseline MGMPI score was calculated following use of the test products in the dental clinic. Subjects refrained from all oral hygiene for 24 hours following use of each test product, and returned to the clinic for a 24-hour MGMPI score. Following a washout period, subjects repeated the procedure with the other test product as per the crossover design. The differences (delta) between baseline plaque scores and 24-hour plaque scores were independently calculated for each study, and the delta values were compared for the two test products in each of the studies. RESULTS: In all three clinical trials, Colgate Total significantly reduced plaque regrowth over a 24-hour time period (p < or = 0.05) compared to Crest Pro-Health. Existing differences were determined via a paired t-test, which confirmed that Colgate Total was statistically significantly different from Crest Pro-Health. CONCLUSION: These in vivo data support the antiplaque benefit of the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice. Additionally, the results support that Colgate Total provides superior efficacy in inhibiting the formation of dental plaque compared to Crest Pro-Health.

A clinical investigation of the efficacy of three commercially available dentifrices for controlling established gingivitis and supragingival plaque.

OBJECTIVE: To assess the efficacy ofa dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride for controlling established gingivitis and supragingival plaque relative to that of a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate, and a dentifrice containing 0.243% sodium fluoride as a negative control. METHODS: Following a baseline examination for gingivitis and supragingival plaque, qualifying adult male and female subjects from the Piscataway, NJ, USA area were randomized into three dentifrice groups. Subjects were instructed to brush their teeth twice daily (morning and evening) for one minute with their assigned dentifrice and a soft-bristled toothbrush. Examinations for gingivitis and supragingival plaque were repeated after six weeks of product use. RESULTS: One-hundred and seventy-one (171) subjects complied with the protocol and completed the study. Relative to the group using the dentifrice with 0.243% sodium fluoride alone, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride group exhibited statistically significant reductions in gingival index and supragingival plaque index scores of 25.3% and 33.0%, respectively, after six weeks of product use. Similarly, relative to the group using the 0.243% sodium fluoride dentifrice, the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 8.1% and 14.1% after six weeks of product use. Further, relative to the 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate dentifrice group, the 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride dentifrice group exhibited statistically significant reductions in gingival index and plaque index scores of 18.7% and 22%, respectively. CONCLUSION: The overall results of this double-blind clinical study support the conclusion that a dentifrice containing 0.3% triclosan/2.0% PVM/MA copolymer/0.243% sodium fluoride is efficacious for the control of established gingivitis and supragingival plaque as compared to a regular fluoride dentifrice, and that it provides a greater level of efficacy for the control of gingivitis and supragingival plaque than does a dentifrice containing 0.454% stannous fluoride, sodium hexametaphosphate, and zinc lactate.

The use of the Modified Gingival Margin Plaque Index (MGMPI) method to investigate the inhibitory effect of various toothpastes on dental plaque formation.

OBJECTIVE: Colgate Total (CTT) is the only FDA-approved toothpaste for antiplaque and antigingivitis benefits. The objective of this study was to compare the impact of Colgate Total Pharma (CTP), a new variant of Colgate Total, with Colgate Regular Toothpaste (CRT) on plaque formation over a 24-hour period following a single use of the dentifrice. METHODS: CTP and CRT were the two test products. CRT was used for a washout product as well. Fifteen male/female subjects who met the inclusion/exclusion criteria were included into this single-blind (preliminary phase) and double-blind (randomized phase) crossover study. Ethical approval and written informed consent were obtained. Preliminary phase: After a one-week washout with CRT, subjects brushed in the dental clinic with CRT before a one-minute use of a test dentifrice. A baseline Modified Gingival Margin Plaque Index (MGMPI) score was calculated. Subjects refrained from oral hygiene for 24 hours, and returned to the clinic for their 24-hour MGMPI score. Subjects entered the second washout phase to repeat as per the crossover design. The above procedures were conducted three times by three independent examiners. Randomized phase: Subjects were randomized to the groups according to a computer-generated randomization schedule. The procedure was carried out as in the preliminary phase, except the washout period between the two products was at least one week and the products (CTP or CRT) were used in a randomized double-blind manner. Plaque scores were recorded as above. RESULTS: CTP provided a significant (p = 0.01) antiplaque effect versus CRT. The results are consistent with previously reported data for CTT. All three examiners demonstrated a strong correlation for this clinical study utilizing the MGMPI methodology. CONCLUSION: This clinical investigation examined the efficacy of a new variant of a commercial dentifrice, historically shown to provide antiplaque and antigingivitis efficacy. It is important to confirm the continued efficacy of new products to consumers and to the profession. Additionally, this clinical trial demonstrated the usefulness of the clinical methodology with respect to consistency in results by three independent clinical examiners. Because this methodology is often employed to document antiplaque benefits of new and existing technologies, it is important to periodically evaluate and confirm its reliability and reproducibility.