Virucidal Activity of Over-the-Counter Oral Care Products Against SARS-CoV-2.

PURPOSE: The oral cavity is an important entry point for SARS-CoV-2 infection. This study tested whether four commercially available mouthrinses and dentifrices have in vitro virucidal activity against SARS-CoV-2 (=4 log10 reduction in viral titer). MATERIALS AND METHODS: One part of stock SARS-CoV-2 virus plus one part 0.3 g/l bovine serum albumin were mixed with eight parts of test product solution. After 30 s for the rinses, or 60 s for the dentifrices, the mixture was quenched in an appropriate neutralizer, serially diluted, and inoculated onto Vero E6 cells to determine viral titer. Triplicate runs were performed for each test condition with appropriate controls for test product cytotoxicity, viral interference, and neutralizer effectiveness. Test products included: 1.5% hydrogen peroxide (H2O2) rinse; 0.07% cetylpyridinium chloride (CPC) rinse; 0.454% stannous fluoride (SnF2) dentifrice A; and 0.454% SnF2 dentifrice B. RESULTS: ?The 1.5% H2O2 rinse, 0.07% CPC rinse, SnF2 dentifrice A, and SnF2 dentifrice B all produced > 4 log10 reduction in SARS-CoV-2 titer. CONCLUSION: All four test products displayed potent virucidal activity in vitro. Clinical studies are warranted to determine what role, if any, these oral care products might play in preventing transmission of SARS-CoV-2 or in the management of patients currently diagnosed with COVID-19 illness.

Gingival transcriptome patterns during induction and resolution of experimental gingivitis in humans.

BACKGROUND: To our knowledge, changes in the patterns of whole-transcriptome gene expression that occur during the induction and resolution of experimental gingivitis in humans were not previously explored using bioinformatic tools. METHODS: Gingival biopsy samples collected from 14 subjects during a 28-day stent-induced experimental gingivitis model, followed by treatment, and resolution at days 28 through 35 were analyzed using gene-expression arrays. Biopsy samples were collected at different sites within each subject at baseline (day 0), at the peak of gingivitis (day 28), and at resolution (day 35) and processed using whole-transcriptome gene-expression arrays. Gene-expression data were analyzed to identify biologic themes and pathways associated with changes in gene-expression profiles that occur during the induction and resolution of experimental gingivitis using bioinformatic tools. RESULTS: During disease induction and resolution, the dominant expression pathway was the immune response, with 131 immune response genes significantly up- or downregulated during induction, during resolution, or during both at P <0.05. During induction, there was significant transient increase in the expression of inflammatory and oxidative stress mediators, including interleukin (IL)-1 alpha (IL1A), IL-1 beta (IL1B), IL8, RANTES, colony stimulating factor 3 (CSF3), and superoxide dismutase 2 (SOD2), and a decreased expression of IP10, interferon inducible T-cell alpha chemoattractant (ITAC), matrix metalloproteinase 10 (MMP10), and beta 4 defensin (DEFB4). These genes reversed expression patterns upon resolution in parallel with the reversal of gingival inflammation. CONCLUSIONS: A relatively small subset (11.9%) of the immune response genes analyzed by array was transiently activated in response to biofilm overgrowth, suggesting a degree of specificity in the transcriptome-expression response. The fact that this same subset demonstrates a reversal in expression patterns during clinical resolution implicates these genes as being critical for maintaining tissue homeostasis at the biofilm-gingival interface. In addition to the immune response pathway as the dominant response theme, new candidate genes and pathways were identified as being selectively modulated in experimental gingivitis, including neural processes, epithelial defenses, angiogenesis, and wound healing.

An anticalculus dentifrice with sodium hexametaphosphate and stannous fluoride: a six-month study of efficacy.

AIM: To compare the anticalculus efficacy of an experimental dentifrice (0.454% stabilized stannous fluoride/sodium hexametaphosphate) with a negative control. METHODS AND MATERIALS: This was a randomized, examiner-blind, parallel group study. After a three-month run-in, qualifying subjects were randomized to the experimental or control dentifrice to use twice a day for six months. Volpe-Manhold Index (V-MI) and oral soft tissue examinations were conducted at baseline, three, and six months. Additional analyses were performed separately at three and six months on three subgroups categorized into high, medium, and low calculus-forming subjects. RESULTS: Compared to the control group, the experimental dentifrice group had a mean calculus score statistically significantly lower at both three months (50%) and six months (55%) post-treatment (p<0.001). Compared to control scores, mean experimental dentifrice calculus scores at three and six months were statistically significantly lower at both points in time for high, medium, and low calculus forming sub-groups (p<0.001). Both products were generally well tolerated. CONCLUSION: The experimental dentifrice revealed significant anticalculus efficacy compared to the control regardless of levels of baseline calculus formation. CLINICAL SIGNIFICANCE: The stannous fluoride/sodium hexametaphosphate dentifrice technology is an effective calculus inhibitor for home care.

Anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice.

OBJECTIVE: Stannous fluoride is a broad-spectrum anti-microbial agent that has been used in dentistry as a chemical adjunct to prevent dental caries and gingivitis. The objective of this study was to assess the anti-gingivitis efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice relative to a negative control. METHODS: This was a randomized, 6-month, double-blind, parallel-group gingivitis study conducted according to the guidelines for evaluating chemotherapeutic products for the control of gingivitis outlined by the American Dental Association. A stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available negative control dentifrice. Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 s using their assigned product. Oral soft-hard-tissue examinations and clinical examinations using the Modified Gingival Index, Gingival Bleeding Index, and the Turesky modification of the Quigley-Hein Plaque Index were performed at baseline, 3 and 6 months post-treatment. RESULTS: A total of 143 subjects were enrolled and 130 of them completed the 6-month study. After 6 months of product usage, the experimental group had 21.7% less gingivitis (p<0.001), 57.1% less bleeding (p<0.001), and 6.9% less plaque (p=0.01) on average compared with the negative control group. No adverse oral soft-hard-tissue effects or extrinsic tooth staining was observed in the study. CONCLUSION: The results demonstrate that use of the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice over a 6-month period provided statistically significant reductions in gingivitis, gingival bleeding, and plaque when compared with a negative control dentifrice.

Antigingivitis efficacy of a stabilized stannous fluoride/sodium hexametaphosphate dentifrice in subjects previously nonresponsive to a triclosan/copolymer dentifrice.

Antimicrobial agents, such as stannous fluoride and triclosan, have been incorporated into dentifrice formulations and shown to be effective in the prevention and reduction of gingivitis. However, not all subjects respond to treatment. The objective of this study was to assess the antigingivitis efficacy of a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice among subjects who were identified as nonresponsive or minimally responsive to a sodium fluoride/triclosan/copolymer dentifrice. This was a 12-week, examiner-blind, single-center study. Forty-one subjects with no or minimal gingivitis response to 6 months of use of a sodium fluoride/triclosan/copolymer dentifrice were enrolled in this study and 38 of them provided complete data. All subjects were provided with a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice to use over the next 3 months (12 weeks). Subjects were instructed to brush twice daily for 60 seconds using their assigned product. Toothbrushing was supervised for 3 days of each week. Clinical examinations using the Löe-Silness Gingival Index were performed at 6 and 12 weeks posttreatment. The 6-month scores after the use of the sodium fluoride/triclosan/copolymer dentifrice served as the baseline. After 12 weeks of product use, participants had statistically significantly less gingivitis by 54% and statistically significantly less bleeding by 55% on average compared to baseline. No adverse oral soft tissue effects were reported in the study. This study demonstrated that the use of an experimental 0.454% stannous fluoride/sodium hexametaphosphate dentifrice over a 12-week period provides a statistically significant and clinically relevant effect in the control of gingivitis among subjects who previously did not respond to 6 months of use of a sodium fluoride/triclosan/copolymer dentifrice.

Anticalculus efficacy and safety of a stabilized stannous fluoride/sodium hexametaphosphate dentifrice.

The purpose of this study was to assess the anticalculus efficacy and long-term safety of a new stannous fluoride dentifrice containing sodium hexametaphosphate. This trial was a randomized, double-blind, parallel-group, 6-month study where, after a prophylaxis, subjects brushed twice daily with either a stabilized 0.454% stannous fluoride/13% sodium hexametaphosphate dentifrice (Crest Pro-Health) or a marketed multibenefit triclosan/copolymer control dentifrice. Study subjects were known to form supragingival calculus and had previously demonstrated the ability to form at least 1.5 mm using the Volpe-Manhold Calculus Index over a 2-month pretest period. Comparisons between treatments for anticalculus efficacy were performed using analysis of covariance. Eighty subjects were randomized into one of two treatment groups after stratification on gender and baseline calculus scores and then monitored for calculus formation, soft tissue tolerance, and extrinsic stain. The mean calculus score for the stannous fluoride/sodium hexametaphosphate group was statistically significantly lower than that of the triclosan/copolymer group at both months 3 and 6 (P < .01). At month 3, the stannous fluoride/sodium hexametaphosphate group had an adjusted mean 54% lower than that of the triclosan/copolymer group. At month 6, the stannous fluoride/sodium hexametaphosphate group had an adjusted mean 56% lower than that of the triclosan/copolymer group. Both dentifrices were well tolerated and neither dentifrice group developed appreciable extrinsic stain over the 6-month trial period. Overall, the stannous fluoride/sodium hexametaphosphate dentifrice had superior anticalculus efficacy relative to the marketed triclosan/copolymer control and a comparable soft tissue safety and extrinsic stain profile.

Desensitizing effect of a stabilized stannous fluoride/Sodium hexametaphosphate dentifrice.

Stannous fluoride (0.4%) has been incorporated into oral hygiene products to reduce dentinal hypersensitivity since the 1960s. The present study was designed to assess the desensitizing efficacy of a stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice compared to a sodium fluoride control dentifrice. This was a double-blind, parallel-group, randomized clinical trial conducted according to the American Dental Association Guidelines for the Acceptance of Products for the Treatment of Dentinal Hypersensitivity. Seventy-seven subjects who met the entrance criteria were stratified based on age, gender, and air-sensitivity scores and randomly assigned to either the stabilized stannous fluoride/sodium hexametaphosphate dentifrice or the sodium fluoride control dentifrice. Subjects were instructed to brush twice daily for 8 weeks. Oral soft tissue examination and efficacy assessments including tactile (Yeaple probe) and thermal (Schiff Air Index) sensitivity were made at baseline, week 4, and week 8. The mean sensitivity score based on the Schiff Air Index for the experimental group was statistically significantly lower than that of the sodium fluoride control group, at both weeks 4 and 8 (P < .0001). The mean sensitivity score based on the Yeaple Probe Index for the stannous fluoride/sodium hexametaphosphate group was statistically significantly higher, indicating a reduction in sensitivity, than that of the sodium fluoride control group, at both weeks 4 and 8 (P < .0001). The results demonstrate that the stabilized stannous fluoride/sodium hexametaphosphate dentifrice provides clinically and statistically significant reductions in dentinal hypersensitivity when compared to the sodium fluoride control dentifrice.

[Two-year disease progression in mild, moderate and advanced chronic periodontitis patients].

OBJECTIVE: To observe two-year natural progression of chronic periodontitis in mild, moderate and advanced periodontitis patients. METHODS: The periodontal status of 169 untreated chronic periodontitis patients aged from 22 to 64, were examined for two years. Periodontal measurements were performed on all teeth except the third molars and 6 sites examined for each tooth. Probing depth (PD), attachment loss (AL), and bleeding on probing (BOP) were measured at baseline, one year, and two year by a same experienced periodontist. Forty-five patients were diagnosed as having mild periodontitis, 87 with moderate, and 37 with advanced periodontitis. The changes of attachment level in these three group patients were analyzed. The site with change of AL greater than 3 mm (DeltaAL > or = 3 mm) were defined as periodontal disease activity (PDA) sites. The occurrence of PDA in three groups was compared. RESULTS: (1) The average AL levels at 1 year and at 2 year were greater than that at baseline in mild, moderate and advanced periodontitis. (2) The percentage of sites with AL > or = 1 mm in three groups all increased from baseline to 1 year and to 2 year. (3) The occurrence of periodontal disease activity increased significantly from mild (0.14% at site level, 15.56% at subject level), moderate (0.39%, 29.89%) to advanced (0.73%, 43.24%) periodontitis patients. (4) The mean baseline AL and PD levels in active sites were greater than that in inactive sites (PD: 3.03 +/- 0.45 vs. 2.87 +/- 0.38, P < 0.05; AL: 2.25 +/- 0.93 vs. 1.77 +/- 0.90, P < 0.01). CONCLUSION: Untreated advanced periodontitis patients were the risk population for further periodontal breakdown.

The comparative efficacy of stabilized stannous fluoride/sodium hexametaphosphate dentifrice and sodium fluoride/triclosan/copolymer dentifrice for the control of gingivitis: a 6-month randomized clinical study.

BACKGROUND: Antimicrobial agents such as stannous fluoride and triclosan have been incorporated into dentifrice formulations and have been shown to be effective in reducing gingivitis. The objective of this study was to compare the anti-gingivitis efficacy of a 0.454% stannous fluoride/sodium hexametaphosphate dentifrice to a positive control triclosan/copolymer dentifrice. METHODS: This was a 6-month, randomized, double-masked, parallel-group study conducted according to the American Dental Association guidelines for evaluating chemotherapeutic products for the control of gingivitis. A 0.454% stannous fluoride/sodium hexametaphosphate dentifrice was tested against a commercially available positive control dentifrice (0.30% triclosan/2.0% Gantrez copolymer). Following baseline measurements, subjects received a dental prophylaxis. Subjects were then instructed to brush twice daily for 60 seconds using their assigned product. Tooth brushing was supervised for 3 days of each week. Clinical examinations using a gingival index were performed at baseline and at 3 and 6 months. RESULTS: A total of 199 subjects were enrolled and 186 completed the 6-month study. Average baseline gingivitis and bleeding scores were similar for the two treatment groups. After 6 months, the experimental group had statistically significantly less gingivitis (25.8%) and statistically significantly less bleeding (27.4%) on average compared to the control group. Neither adverse oral soft tissue effects nor tooth staining were reported. CONCLUSION: Within the limits of the study protocol, the results demonstrated superior therapeutic benefits for the stabilized 0.454% stannous fluoride/sodium hexametaphosphate dentifrice in reducing gingivitis compared to the triclosan/copolymer control in this partially supervised study.

An experimental gingivitis study to evaluate the clinical effects of a stannous fluoride dentifrice.

PURPOSE: A double blind, controlled, parallel group trial utilizing the experimental gingivitis model was performed on thirty young adults to evaluate the clinical effects of a 0.45% stannous fluoride dentifrice used as a slurry on dental biofilm formation and the development of gingivitis. MATERIAL AND METHODS: Following a thorough examination and oral prophylaxis procedures, subjects were randomly assigned to apply one of the following dentifrices twice daily over a three-week period: A) dentifrice slurry without active ingredients; B) 0.45% stannous fluoride gel; and C) Colgate Total dentifrice slurry (0.30% triclosan, 0.24% sodium fluoride, 2% copolymer). RESULTS: After three weeks, the stannous fluoride dentifrice significantly (p < 0.05) reduced gingivitis compared with the Colgate Total group by 39.7%. Gingival bleeding was also reduced relative to the Colgate Total group. This difference was statistically significant (P < 0.05). During the experimental period, the mean PII scores increased almost linearly in all three groups without yielding any statistically significant differences. CONCLUSIONS: The results of this clinical trial demonstrated that, over a three-week period, the application of a 0.45% SnF2 gel significantly inhibited the onset of gingivitis compared to Triclosan/sodium fluoride/copolymer (Colgate Total). However, neither stannous fluoride nor Triclosan/sodium fluoride/ copolymer (Colgate Total) possessed sufficient antimicrobial activity to suppress biofilm formation in the absence of regular oral hygiene practices.

A clinical study to assess the breath protection efficacy of denture adhesive.

This randomized and controlled, examiner-blind, 3-period, crossover clinical trial was designed to determine the effect of an experimental denture adhesive, a marketed denture adhesive (European Fixodent( Fresh), or no denture adhesive on the breath odor of 37 adults wearing full maxillary and mandibular dentures. Breath quality was measured at baseline and at 3 and 6 hours after the start of each treatment period via monitoring of volatile sulfur compounds (VSCs) using a halimeter and second-person organoleptic grading. A 48-hour washout phase separated treatment periods. There were no statistically significant differences in VSCs between any of the treatment regimens over 6 hours. Both the denture adhesive treatments were superior in breath quality improvement in organoleptic scores compared to no denture adhesive at 3 and 6 hours (p=0.0001). This research demonstrates the ability of both an experimental and marketed denture adhesive to deliver superior second-person breath benefits relative to no adhesive. The results indicate that Fixodent denture adhesives provide the denture wearer with a noticeable improvement in breath.

Triclosan/pyrophosphate dentifrice: dental plaque and gingivitis effects in a 6-month randomized controlled clinical study.

A double-blind, parallel, randomized and controlled clinical trial was conducted on 186 subjects over six months to assess the effects of a 0.28% triclosan/5% pyrophosphate (with NaF/silica) dentifrice on dental plaque and gingivitis as compared to a NaF/silica negative control dentifrice. An initial examination was performed to assess the health of the oral soft and hard tissues and to measure plaque (by Turesky modified Quigley-Hein Plaque Index), gingivitis (by Löe-Silness Gingival and Ainamo and Bay Gingival Bleeding [GBI] indices). Only those subjects with a GBI score > or = 5 were accepted into the study. Each enrolled subject received an oral prophylaxis and was requested to brush and floss twice per day with the negative control NaF/silica dentifrice. After one month, the subjects were recalled and a baseline examination was performed for each of the previously described parameters. Following the baseline examination, the subjects received another oral prophylaxis. The subjects were then separated by gender and by baseline GBI scores of < or = 7 or > 7 and arrayed by the changes in GBI bleeding sites from initial to baseline. Within strata, subjects were randomly assigned to brush twice per day with either the triclosan/pyrophosphate dentifrice or the negative control dentifrice. The subjects were subsequently examined for all of the above-described parameters following use of the test dentifrices for five weeks, three and six months. The data generated in this trial were analyzed using an analysis of covariance on all indices for all subjects completing the examinations. The results from this study demonstrated that the use of the triclosan/pyrophosphate dentifrice resulted in statistically significant reductions of dental plaque compared to the control by 10% (p < 0.05), 15.4% (p < 0.01) and 13.9% (p < 0.01) at five weeks, three and six months, respectively. However, there were no statistically significant differences between the test dentifrices for any of the gingivitis or gingival bleeding evaluations throughout the study. Based on 1) the fact that subjects possessed plaque-induced gingivitis in this clinical study, 2) the similarity in the magnitude of the plaque reductions observed from the triclosan/pyrophosphate dentifrice relative to those reported for other triclosan-containing dentifrices, 3) the similarity in the dose of triclosan relative to other triclosan dentifrices, and 4) the reported magnitude of gingivitis reductions from other triclosan-containing dentifrices, these findings were unexpected. Possible explanations of these results are that the triclosan/pyrophosphate dentifrice may be uniquely different from other triclosan dentifrices relative to its effects on gingivitis, or alternatively, the clinical design utilized here may not be optimized for triclosan/pyrophosphate dentifrice.

A clinical methods study of the effects of triclosan dentifrices on gingivitis over six months.

The basic design for human clinical trials which examine prevention of gingivitis recurrence is well known. However, the anti-gingivitis efficacy of triclosan-containing dentifrices has not been routinely demonstrated using this design, regardless of formulation. In an effort to better understand the subtleties of design which show triclosan efficacy, a study was undertaken to prospectively test how subjects with a range of baseline disease levels (which encompassed the range of gingivitis severity documented in the triclosan literature) benefit from a triclosan dentifrice. This trial was a randomized, double-blind, parallel group, six-month study where subjects brushed twice daily with either triclosan/pyrophosphate, triclosan/copolymer, triclosan placebo or sodium fluoride control (NaF) dentifrice following a prophylaxis. Both gingivitis and bleeding were measured using the Löe-Silness Gingival Index (GI) and plaque was measured using the Turesky Plaque Index. Comparisons between treatments were performed using an analysis of covariance. At month 3, the triclosan/pyrophosphate group had a relative mean plaque benefit of 14.4% versus the triclosan placebo group (with an associated p-value of 0.004), and subjects using triclosan/copolymer had a mean reduction in GI bleeding sites of 16.2% relative to those brushing with the NaF control (with an associated p-value of 0.031). The overall results did not demonstrate a treatment effect for gingivitis or plaque for either triclosan-containing dentifrice at month 6. There was evidence of modest anti-gingivitis efficacy in the triclosan placebo. In an effort to better understand how baseline disease severity may have impacted the trial outcome, additional analyses were performed to investigate whether the magnitude of a triclosan effect was related to baseline gingivitis levels. An analysis of covariance model incorporating a baseline group interaction effect indicated that the magnitude of the treatment differences depended on the baseline scores The effect was most pronounced for GI bleeding sites. Further analysis showed that differences between triclosan dentifrices and the NaF control dentifrice were only present for subjects with more than 33 to 63 bleeding sites, depending on the specific comparison. These findings were illustrated through a series of subset analyses on subjects with > or = 20 (entire study population), > or = 31, > or = 40 and > or = 45 baseline GI bleeding sites. The magnitude of the treatment effect for both GI and GI bleeding sites increased with each succeeding subset. Unlike that required for other antimicrobial agents used in oral care products, these findings suggest that a study design which includes subjects with more severe gingivitis at baseline has the required sensitivity to demonstrate treatment benefits for triclosan dentifrices.