Remineralisation of enamel and dentine with stabilised stannous fluoride dentifrices in a randomised cross-over in situ trial.

OBJECTIVES: To compare the remineralisation efficacy and ion bioavailability of two novel SnF2-containing dentifrices in a blinded, cross-over, randomised in situ clinical study. METHODS: Six participants wore removal palatal appliances holding human enamel and dentine blocks with subsurface lesions. Appliances were worn for two treatment periods of 14 consecutive days each, with a one-week washout period in-between. Participants were randomly allocated to rinse with a 1:5 diluted coded slurry of one of two dentifrices containing either 5 % casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) +1100 ppm F as SnF2 [MIPOP], or 1100 ppm F as SnF2 [CT], for 1 min, four times a day. Saliva was collected post-treatment and analysed for tin, calcium, inorganic phosphate and fluoride ions using atomic absorption spectrophotometry and ion chromatography. Enamel and dentine lesions were analysed for percent remineralisation (%R) using transverse microradiography and percent surface microhardness recovery (%SMHR). RESULTS: MIPOP released significantly higher F (3.00 ± 0.27 mM), Ca (15.23 ± 3.23 mM) and Sn (1.18 ± 0.13 mM) into saliva whereas CT released 2.89 ± 0.32 mM F and only 0.84 ± 0.11 mM Ca and 0.28 ± 0.10 mM Sn. MIPOP produced significantly higher %R than CT: 25.6 ± 1.5 % compared to 15.2 ± 0.7 % in enamel, and 33.6 ± 3.1 % compared to 20.6 ± 1.1 % in dentine. Additionally, MIPOP produced significantly higher %SMHR (18.2 ± 7.9 %) compared to CT (4.1 ± 0.6 %). CONCLUSIONS: Both dentifrices promoted remineralisation, but the MIPOP dentifrice with added CPP-ACP and the ion-stabilising effects of CPP released higher amounts of bioavailable tin and produced significantly higher remineralisation and surface microhardness recovery. CLINICAL SIGNIFICANCE: Modern dentifrices contain SnF2 for a range of oral health benefits. Challenges associated with stability of these formulations can affect ion bioavailability, reducing efficacy. Two dentifrices with SnF2 promoted remineralisation in situ, however the dentifrice with the added saliva biomimetic CPP-ACP was superior and therefore may produce greater health benefits.

Influence of Different Mouthwashes on the Efficacy of Fluoridated Dentifrices in Prevention of Enamel Erosion: An In Vitro Study.

AIM: The purpose of the current study was to evaluate the impact of three various mouthwashes on the effectiveness of fluoride dentifrices in preventing enamel erosion. MATERIALS AND METHODS: A total of 120 sound intact human premolar teeth which were extracted for orthodontic treatment were selected for the study. A 3 × 3 mm window section was positioned in the middle of the coronal surface of the tooth in order to define the study area. Each sample was placed in a solution of 1% citric acid (pH 3.5) for 10 minutes in order to produce an eroded surface. All samples were divided into two main groups (60 samples each) as follows: Group A for sodium fluoride dentifrices and group B for stannous fluoride dentifrices, again it is subdivided into: CHX: Chlohex ADS®, EO: Listerine®, CPC: Colgate® Plax (20 samples in each subgroup). After that, samples underwent the pH cycling model for 5 days. Samples were examined for surface loss using a scanning electron microscope. RESULTS: In sodium fluoride dentifrices group, before intervention, the surface loss was 3.12 ± 1.03 in CHX group, 3.08 ± 1.20 in EO group, and 3.09 ± 0.96 in CPC group. After intervention, the less surface loss found with CHX group (2.18 ± 0.84), followed by CPC (2.34 ± 0.74) and EO group (2.46 ± 0.97). In stannous fluoride dentifrices group, before intervention, the surface loss in CHX group was 3.26 ± 1.19, in EO group, it was 3.18 ± 1.31, and in CPC group, it was 3.22 ± 1.06. After intervention, the less surface loss found with CHX: group (1.90 ± 0.54), followed by CPC (2.24 ± 0.28) and EO group (2.38 ± 0.20). CONCLUSION: The present study concluded that the fluoride dentifrices' preventive effects against tooth surface loss were unaffected by a different mouthwashes with varying compositions and major constituents. In terms of erosion, fluoridated toothpaste containing stannous fluoride was found to provide better surface loss protection than sodium fluoride. CLINICAL SIGNIFICANCE: Primary prevention and the eradication of contributing causes are the greatest strategies for preventing erosion. Simultaneously, antibacterial agent in the mouthwashes may help in enhancing the effect of fluoride in the enamel, owing to their high affinity for teeth structures. Therefore, in addition to cause-related treatment, further efforts to reduce tooth tissue loss are also necessary.

Iron oxide nanozymes stabilize stannous fluoride for targeted biofilm killing and synergistic oral disease prevention.

Dental caries is the most common human disease caused by oral biofilms despite the widespread use of fluoride as the primary anticaries agent. Recently, an FDA-approved iron oxide nanoparticle (ferumoxytol, Fer) has shown to kill and degrade caries-causing biofilms through catalytic activation of hydrogen peroxide. However, Fer cannot interfere with enamel acid demineralization. Here, we show notable synergy when Fer is combined with stannous fluoride (SnF2), markedly inhibiting both biofilm accumulation and enamel damage more effectively than either alone. Unexpectedly, we discover that the stability of SnF2 is enhanced when mixed with Fer in aqueous solutions while increasing catalytic activity of Fer without any additives. Notably, Fer in combination with SnF2 is exceptionally effective in controlling dental caries in vivo, even at four times lower concentrations, without adverse effects on host tissues or oral microbiome. Our results reveal a potent therapeutic synergism using approved agents while providing facile SnF2 stabilization, to prevent a widespread oral disease with reduced fluoride exposure.

A randomized controlled clinical evaluation of desensitization efficacy of a newly developed toothpaste with highly stabilized SnF2.

PURPOSE: To assess the relief of dentin hypersensitivity of the new toothpaste with stabilized stannous fluoride (SnF2) versus a marketed standard fluoride toothpaste as a negative control and a marketed anhydrous SnF2 toothpaste as a positive control. METHODS: This was a single-centered, randomized, controlled, double blind, clinical trial. 96 participants with hypersensitivity were enrolled in this 4-week clinical study. Electrical stimulation and evaporative air tests were performed to evaluate the desensitization efficacy. Clinical assessments were made at baseline, and after 3 days, 1 week, 2 weeks and 4 weeks of twice-daily brushing. Additionally, the influence of Sn² ⁺ species on desensitization was evaluated using bovine dentin specimens treated with toothpaste. RESULTS: All 96 enrolled participants were randomized. 96 participants completed all evaluations. Participants had an average age (SD) of 47.0 (10.5) years; 45% of participants were female. Both SnF2 toothpastes showed superior desensitization efficacy compared to the negative control toothpaste, the conventional sodium monofluorophosphate (SMFP) toothpaste, after a week. The new stabilized SnF2 toothpaste demonstrated improved electrical stimulation benefits compared to the negative control toothpaste, with increases of 15.1% after 3 days, 34.2% after 1 week, 66.3% after 2 weeks, and 111.6% after 4 weeks. Additionally, it showed relative verbal evaluation scale (VES) benefits of 14.2% after 3 days, 37.6% after 1 week, 28.9% after 2 weeks, and 37.4% after 4 weeks. The stabilized SnF2 toothpaste exhibited desensitization properties comparable to those of a commercial anhydrous SnF2 toothpaste, which typically produces undesirable side effects in the mouth. Toothpastes containing 0.454 % SnF2 exhibited perfect occlusion of dentin tubules. CLINICAL SIGNIFICANCE: The stabilized 0.454% SnF2 toothpaste exhibited significantly greater dentin hypersensitivity relief within only a week and comparable property to commercial anhydrous SnF2 toothpaste.

Erosion-inhibiting potential of the stannous fluoride-enriched CPP-ACP complex in vitro.

Currently available anti-erosive agents only provide partial protection, emphasizing the need to enhance their performance. By characterizing erosive enamel wear at the nanoscale, the aim of this in vitro study was to assess the anti-erosive effects of SnF2 and CPP-ACP both individually and synergistically. Erosion depths were assessed longitudinally on 40 polished human enamel specimens after 1, 5, and 10 erosion cycles. Each cycle comprised one-min erosion in citric acid (pH 3.0) and one-min treatment in whole saliva (control group) or a slurry of one of the three anti-erosive pastes (10% CPP-ACP; 0.45% SnF2 (1100 ppm F); or SnF2/CPP-ACP (10% CPP-ACP + 0.45% SnF2)) (n = 10 per group). Scratch depths were assessed longitudinally in separate experiments using a similar protocol after 1, 5, and 10 cycles. Compared with the control groups, all slurries reduced erosion depths after 1 cycle (p ≤ 0.004) and scratch depths after 5 cycles (p ≤ 0.012). The order of anti-erosive potential was SnF2/CPP-ACP > SnF2 > CPP-ACP > control for erosion depth analysis, and SnF2/CPP-ACP > (SnF2 = CPP-ACP) > control for scratch depth analysis. These data provide 'proof of concept' evidence that SnF2/CPP-ACP has superior anti-erosive potential compared to SnF2 or CPP-ACP alone.

A randomized double-blind clinical trial evaluating comparative plaque and gingival health associated with commercially available stannous fluoride-containing dentifrices as compared to a sodium fluoride control dentifrice.

BACKGROUND: Gingivitis is a non-specific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices, including utilization of a dentifrice that could significantly improve plaque accumulation and gingival inflammation, is desirable to prevent and treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a new stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra acetic acid (EDTA) as an anti-tartar agent to reduce plaque index and gingival index over a 3-month study period compared to other commercially-available fluoride-containing dentifrices. METHODS: This double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using one of five commercially available fluoride-containing dentifrices The dentifrices tested contained: 0.454% stannous fluoride and 2.6% EDTA (D1), 0.24% sodium fluoride (C), and 0.454% stannous fluoride (D2-D4). One hundred fifty subjects participated over a 3-month period. Co-primary endpoints were improvements in plaque index (PI) and modified gingival index (mGI) from baseline values. No professional cleaning was performed during the study period. RESULTS: All subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using dentifrice 1 (D1) showed statistically significantly greater reductions in PI, mGI, and modified sulcular bleeding index (mSBI) compared with all other commercially-available dentifrices tested (p < 0.00001). CONCLUSIONS: A new dentifrice with 0.454% stannous fluoride and 2.6% EDTA demonstrated significant improvements in clinical parameters associated with gingivitis compared to other sodium and stannous fluoride containing dentifrices.

Occlusion of dentinal tubules on periodontally involved teeth by dentifrice containing stannous fluoride and sodium fluoride.

PURPOSE: This study examined the occlusion effect of a dentifrice containing stannous fluoride (SnF2) and sodium fluoride (NaF) on periodontally involved teeth in comparison with healthy teeth using scanning electron microscopy (SEM) in comparison with a dentifrice containing NaF alone. METHODS: Sixty dentine samples obtained from single-rooted premolars, 15 of them extracted for orthodontic reasons (Group H) and 15 because of periodontal destruction (Group P), were included in the study. Each group of specimens was further divided into subgroups: HC and PC (control), H1 and P1 (treated with SnF2 and NaF), and H2 and P2 (treated with NaF). The samples were brushed twice a day for 7 days, kept in artificial saliva, and examined by SEM. The diameters of open tubules and the numbers of tubules were assessed at ×2,000 magnification. RESULTS: The H and P groups showed similar diameters of open tubules. The numbers of open tubules in Groups H1, P1, H2, and P2 were significantly lower than in Groups HC and PC (P < 0.001), and consistent with the percentages of occluded tubules. Group P1 had the highest percentage of occluded tubules. CONCLUSIONS: Although both dentifrices were found to successfully occlude dentinal tubules, the dentifrice containing SnF2 and NaF provided the highest degree of occlusion in periodontally involved teeth.

Better living through chemistry? A randomized, double-blind controlled study evaluating the efficacy of plaque control and gingival health impacts of a novel stannous fluoride-containing gel.

BACKGROUND: Gingivitis is a nonspecific inflammatory lesion in response to the accumulation of oral biofilm and is a necessary precursor to periodontitis. Enhanced oral hygiene practices are necessary to reverse gingivitis and a dentifrice that could provide significant clinical reductions in plaque accumulation and gingival inflammation would be desirable to treat gingivitis and potentially prevent progression to periodontitis. This clinical study aimed to investigate the effect of a novel stannous fluoride-containing dentifrice with 2.6% ethylenediamine tetra-acetic acid (EDTA) as an antitartar agent to reduce Plaque Index (PI) and Gingival Index over a 3-month study period. METHODS: This double-blind, randomized controlled clinical study evaluated plaque, gingival inflammation, and sulcular bleeding in patients using either a novel dental gel containing 0.454% stannous fluoride and 2.6% EDTA or a dentifrice with 0.24% sodium fluoride. Sixty subjects participated over a 3-month period. Co-primary endpoints were improvements in PI and Modified Gingival Index (mGI) from baseline values. No professional cleaning was performed during the study period. RESULTS: All subjects in the study demonstrated statistically significant improvements in all measures of oral hygiene over the 3-month study period. Subjects using the novel dental gel showed statistically significantly greater reductions in PI (ΔPI) [(-1.43 ± 0.34; -0.49 ± 0.13) (p < 0.00001)], mGI (ΔmGI) [(-1.11 ± 0.22; -0.16 ± 0.12) (p < 0.00001)], and modified sulcular bleeding index (ΔmSBI) [(-1.15 ± 0.18; -0.20 ± 0.07) (p < 0.00001)]. CONCLUSIONS: The novel dental gel demonstrated significant improvements in clinical parameters associated with gingivitis compared to a commercially available sodium fluoride dentifrice.

Novel findings on anti-plaque effects of stannous fluoride.

PURPOSE: To evaluate the antiplaque effects for 0.454% bioavailable gluconate chelated stannous fluoride (SnF2) dentifrices versus controls by clinical model, plaque index, tooth surface and tooth type in a pooled analysis. METHODS: Randomized controlled trials (RCTs) were conducted to evaluate plaque effects of SnF2 dentifrices from the same formulation family over the past 30 years. Forty-four 4-day and longer-term (≥ 2 weeks) RCTs conducted in six countries with 3,336 subjects using Turesky Modified Quigley-Hein Plaque Index, Rustogi Modification of the Navy Plaque Index, Digital Plaque Imaging Analysis, and Silness and Löe Plaque Index were included. RESULTS: In 13 and 11 longer-term studies assessing SnF2 dentifrice versus a negative or positive control, respectively, standardized differences in average plaque score of -1.15 (95% CI: -1.61, -0.69) and -0.74 (95% CI: -1.20, -0.28) were observed (P ≤ 0.011), favoring SnF2. Reductions represented a 19% and 16% benefit versus the negative and positive control, respectively. In 18 and five 4-day studies assessing SnF2 dentifrice versus a negative (NaF/SMFP) or positive (triclosan/chlorhexidine) control, respectively, differences in average 4-day plaque score of -0.27 (95% CI: -0.31, -0.23) and -0.15 (95% CI: -0.25, -0.06) were observed (P≤ 0.001) favoring SnF2. Reductions represented a 14% and 11% benefit versus the negative and positive control, respectively. Significant antiplaque benefits for SnF2 dentifrice were seen regardless of clinical model, plaque index, tooth surface or type, including brushed and unbrushed surfaces (P≤ 0.049). CLINICAL SIGNIFICANCE: Bioavailable gluconate chelated SnF2 dentifrices showed consistent plaque inhibition versus negative and positive controls across all conditions evaluated. Importantly, the effect on unbrushed surfaces illustrated the significant plaque inhibition benefit of SnF2 beyond mechanical plaque removal.

[What is the functioning of tin in stannous fluoride?] / Wat is de werking van tin in tinfluoride?

Stannous fluoride is one of the first fluoride compounds that were added to dentifrices. Besides the well-known effect of fluoride, the presence of tin could also have an effect on dental health by its anti-microbial activity and the ability to form insoluble metal salts. The functioning of stannous fluoride has been studied extensively in many scientific publications. On the basis of the available literature, the use of stannous fluoride instead of sodium fluoride could be advantageous in case of gingivitis, halitosis, dentine hypersensitivity, or erosion. The effects that were found are statistically significant, albeit rather small, which makes it harder to predict the actual gain in dental health or the clinical relevance for an individual patient.

A commercial SnF2 toothpaste formulation reduces simulated human plaque biofilm in a dynamic typodont model.

AIMS: We present a dynamic typodont biofilm model (DTBM) incorporating (1) human dentition anatomy, (2) fluid flow over intermittently fluid bathed tooth surfaces and (3) an oxic headspace to allow aerobic and anaerobic niches to develop naturally, as a screening tool to assess the effect of stannous fluoride (SnF2 ) toothpaste against a simulated human plaque biofilm (SPB). METHODS AND RESULTS: First, hydroxyapatite (HA) coupons were inoculated with human saliva/plaque and cultured at 37°C under air. Selected species representative of common commensal and anaerobic pathogens were quantified for relative abundance changes over 4 days by PCR densitometry to confirm the culture conditions allowed the proliferation of these species. A continuous culture DTBM reactor on a rocker table was inoculated with saliva/plaque and incubated at 37°C for 24 h. Tooth shear stress was estimated by particle tracking. A SnF2 toothpaste solution, or a sham rise was administered twice daily for 3 days to mimic routine oral hygiene. SPB biomass was assessed by total bacterial DNA and methylene blue (MB) staining. Early colonizer aerobes and late colonizer anaerobes species were detected in the HA and DTBM, and the trends in changing abundance were consistent with those seen clinically. CONCLUSIONS: Treatment with the SnF2 solution showed significant reductions of 53.05% and 54.4% in the SPB by MB staining and DNA, respectively. SIGNIFICANCE AND IMPACT OF STUDY: The model has potential for assessing dentition anatomy and fluid flow on the efficacy of antimicrobial efficacy against localized SPB and may be amenable to the plaque index clinical evaluation.

Reduction in erosive tooth wear using stannous fluoride-containing dentifrices: a meta-analysis.

Dentifrices containing different active agents may be helpful to allow rehardening and to increase the resistance of the eroded surface to further acids or mechanical impacts. This study aimed to compare the effects of conventional (sodium fluoride [NaF]) and stannous fluoride (SnF2)-containing dentifrices on reducing erosive tooth wear (ETW). The PubMed/MEDLINE, Scopus, LILACS, BBO, EMBASE, TRIP electronic databases, and grey literature were searched until January 2021 to retrieve relevant in vitro and in situ studies related to research question. There were no restrictions on publication year or language. Two authors independently selected the studies, extracted the data, and assessed the risk of bias. ETW data were pooled to calculate and compare both dentifrices (overall analysis) and in vitro and in situ studies separately (subgroup analysis). Statistical analyses were performed using RevMan5.3 with a random effects model. Of 820 potentially eligible studies, 101 were selected for full-text analysis, and 8 were included in the systematic review and meta-analysis. There was a significant difference between SnF2-containing dentifrices and NaF dentifrices only for in vitro studies (p=0.04), showing a higher effect of the SnF2-containing dentifrices against the erosion/abrasion (effect size: -6.80 95%CI: -13.42; -0.19). Most in vitro and in situ studies had high and low risk of bias, respectively. In vitro literature suggests that the ETW reduction is greater when using SnF2-containing dentifrices instead NaF-containing dentifrices. However, the evidence level is insufficient for definitive conclusions. Clinical trials are necessary for a better understanding of the effect of these compounds on ETW.

A randomised clinical study investigating efficacy of a stannous fluoride toothpaste in improving gingival health after 3 weeks' use.

BACKGROUND: This examiner-blind, stratified, parallel study aimed to evaluate the anti-gingivitis efficacy of a non-aqueous (anhydrous) 0.454% w/w stannous fluoride toothpaste ('Test') versus a sodium monofluorophosphate toothpaste ('Control') in people with clinically-confirmed mild-moderate gingivitis. Plaque-induced gingivitis can progress to irreversible periodontitis if left untreated. This can be controlled by an effective oral hygiene regimen such as one including toothbrushing with a toothpaste containing the chemotherapeutic agent stannous fluoride. Long-term studies over 4-12 weeks have shown the efficacy of stannous fluoride; however, shorter term studies are needed to examine if the effects on measures of gingivitis and plaque control occur sooner. METHODS: Eligible participants were randomised to 3 weeks' twice-daily brushing (for 1 min) with Test or Control toothpastes. The primary efficacy variable was between-treatment difference in Bleeding Index (BI) at 3 weeks; secondary variables were between-treatment differences in number of bleeding sites, modified Gingival Index (MGI), and Turesky modification of the Quigley-Hein Plaque Index (TPI) at Weeks 2 and 3. RESULTS: A statistically significant (p < 0.0001) lower BI score was reported for Test (n = 65) versus Control (n = 65) groups at Week 2 (mean difference: - 0.07 [95% CI - 0.9, - 0.05]; 32.7% difference) and Week 3 (mean difference: - 0.06 [95% CI - 0.8, - 0.04]; 29.2% difference). The Test group also demonstrated statistically significant lower (all p < 0.0001 versus Control) number of bleeding sites (Weeks 2/3 mean difference [95% CI]: - 10.04 [- 12.3, - 7.5]/ - 8.2 [- 11.1, - 5.3] sites; 33.0%/29.3% difference); MGI score (Weeks 2/3 mean difference [95% CI]: - 0.09 [- 0.13, - 0.06]/ - 0.10 [- 0.14, - 0.06]; 4.3%/4.7% difference); overall TPI score (Weeks 2/3 mean difference [95% CI]: - 0.45 [- 0.55, - 0.35/ - 0.42 [- 0.53, - 0.30] difference; 16.0%/15.1% difference) and interproximal TPI score (Weeks 2/3 mean difference [95% CI]: - 0.42 [- 0.52, - 0.30]/ - 0.41 [- 0.52, - 0.29]; 14.6%/14.1% difference). Both toothpastes were generally well tolerated. CONCLUSION: Three weeks' twice-daily brushing with the 0.454% w/w stannous fluoride Test toothpaste compared to the Control toothpaste led to statistically significant lower gingival bleeding, gingival inflammation and plaque levels in adults with mild-moderate gingivitis. These results indicate that plaque and gingivitis-reducing benefits of 0.454% w/w stannous fluoride may be seen from 2 weeks' use. Trial registration ClinicalTrials.gov Identifier: NCT04050722; 08/08/2019.

A randomized, controlled comparison of a stannous-containing dentifrice for reducing gingival bleeding and balancing the oral microbiome relative to a positive control.

PURPOSE: To evaluate the effect of a stannous-containing fluoride dentifrice on gingival health and on the composition of the oral microbiome versus a positive control dentifrice over 2 weeks, in a population of healthy adults with self-reported sub-optimal oral health at baseline. METHODS: This was a randomized, controlled, double-blind clinical study. 87 subjects with self-reported sub-optimal oral health at enrollment were randomized to brush twice daily with either an experimental dentifrice (n= 43) or a marketed positive control dentifrice (n= 43), both containing stannous chloride and 0.321% sodium fluoride. All subjects used a soft, manual toothbrush that was provided. The Mazza modification of gingival papillary bleeding Index (Mazza GI) was used to assess gingivitis at baseline and at Week 2. Supragingival plaque was collected for microbiome composition analyses at baseline, Week 1, and Week 2. RESULTS: 83 subjects completed the study. Baseline means were balanced between the treatment groups (P> 0.34). At Week 2, the positive control dentifrice demonstrated a 63.8% statistically significant (P< 0.0001) reduction relative to baseline for Mazza number of gingival bleeding sites. The experimental stannous containing dentifrice provided a comparable 63.5% gingival bleeding reduction versus baseline. There was no significant (P= 0.96) difference between the two dentifrices for either Mazza GI score or number of bleeding sites measured. The microbiome composition analysis at Week 1 found that 28 gingivitis-associated bacterial genera, including Porphyromonas, Tannerella, and Fusobacterium, were significantly inhibited in both dentifrice groups when compared to baseline, while the relative abundance of genera associated with oral health, such as Rothia, Streptococcus, Haemophilus, and Lautropia, was significantly elevated after treatment. These improvements in the oral ecosystem were sustained at Week 2. CLINICAL SIGNIFICANCE: An experimental stannous-containing sodium fluoride dentifrice significantly reduced gingival bleeding comparable to a positive control, and both dentifrices promoted a shift in the oral microbiome towards those genera associated with oral health in a subject population with self-reported sub-optimal oral health at baseline.

A clinical study to assess the gingivitis reduction efficacy of a novel stannous-containing fluoride dentifrice.

PURPOSE: To assess the gingivitis reduction efficacy of a novel stannous-containing fluoride dentifrice relative to a negative control. METHODS: 100 generally healthy adults with 10 or more gingival bleeding sites based on the Mazza Modification of the Papillary Bleeding Index (Mazza GI) were enrolled into a 2-week randomized, controlled, double-blind, single-center, two-treatment, parallel group clinical study. The subjects were randomly assigned to the stannous-containing dentifrice group (experimental group) or the sodium fluoride dentifrice group (negative control group). An oral examination and Mazza GI examination were conducted at Baseline, Day 3 and Week 2 post-baseline by a qualified dental examiner. RESULTS: 98 subjects completed the study. The experimental group provided a significant reduction in Mazza GI scores and number of bleeding sites relative to baseline at Day 3 and Week 2 (P< 0.0001). The negative control did not provide significant reductions versus baseline for either measure at either timepoint (P> 0.3). At Day 3, the experimental group provided a statistically significant reduction of Mazza GI scores and number of bleeding sites compared with the negative control group (P< 0.0001). At Week 2, the experimental group showed 24.11% lower Mazza GI scores and 54.81% fewer bleeding sites than the negative control group (P< 0.0001). CLINICAL SIGNIFICANCE: The results demonstrated that the novel stannous-containing fluoride dentifrice had a superior anti-gingivitis effect compared to the sodium fluoride negative control dentifrice, which was evident as quickly as 3 days after use and further improved after 2 weeks of usage.

Randomized clinical trial assessing anti-gingivitis efficacy of two stannous fluoride dentifrices and zinc/arginine dentifrice.

PURPOSE: To evaluate the anti-gingivitis efficacy of two bioavailable stannous fluoride (SnF2) dentifrices versus a zinc/arginine dentifrice and a negative control dentifrice, and to compare the plaque control benefits. METHODS: This was a single-center, randomized, controlled, four-treatment, parallel-group, double-blind, 3-month clinical trial. Healthy adult subjects with gingivitis were randomly assigned to one of four different dentifrice treatment groups: SnF2 dentifrice A, SnF2 (1,100 ppm F) + sodium fluoride (350 ppm F) + sodium hexametaphosphate (Procter & Gamble); SnF2 dentifrice B, SnF2 (1,100 ppm F) + sodium fluoride (350 ppm F) + citrate (Procter & Gamble); Zn/Arg dentifrice, zinc/arginine + sodium fluoride (1,450 ppm F) (Colgate-Palmolive); negative control dentifrice, sodium monofluoro-phosphate (1,000 ppm F) + sodium fluoride (450 ppm F) (Colgate-Palmolive). Subjects brushed with their assigned treatment dentifrice and an assigned manual toothbrush (Oral-B Indicator) for 1 minute, twice daily, for the duration of the study. Gingivitis was assessed at Baseline and at Weeks 2, 4 and 12 by calculating the total number of gingival bleeding sites using the Gingival Bleeding Index, and plaque was assessed at Baseline and at Week 12 using the Turesky Modified Quigley-Hein Index. A repeated measures model was carried out across Weeks 2, 4, and 12 to determine bleeding efficacy (total number of bleeding sites). An ANCOVA with baseline plaque as the covariate was used to evaluate plaque efficacy at Week 12. RESULTS: 161 subjects were randomized (mean age= 38.8 years). 154 subjects completed the study and 153 had evaluable data at Week 12. The mean (SD) number of Baseline bleeding sites overall was 78.74 (31.16) with no significant difference between groups (P= 0.537). SnF2 dentifrice A significantly reduced the number of bleeding sites relative to the negative control dentifrice at Weeks 2, 4 and 12 by 15.4%, 13.7% and 17.2%, respectively. SnF2 dentifrice B significantly reduced the number of bleeding sites relative to the negative control dentifrice at Week 4 by 13.9% (P= 0.041). Relative to the Zn/Arg dentifrice, SnF2 dentifrice A produced significantly greater reductions in gingival bleeding sites at Weeks 2, 4 and 12 by 23.4%, 17.2% and 20.9%, respectively (P≤ 0.007). SnF2 dentifrice B produced significantly greater bleeding reductions versus the Zn/Arg dentifrice at Weeks 4 and 12 by 17.4% and 14.4%, respectively (P≤ 0.035). The Zn/Arg dentifrice did not differ significantly in the number of bleeding sites (P≥ 0.127) or plaque (P= 0.175) relative to the negative control dentifrice. Both SnF2 dentifrices significantly reduced plaque levels (P≤ 0.029) relative to both negative control dentifrice and Zn/Arg dentifrice at Week 12. All dentifrices were well tolerated. CLINICAL SIGNIFICANCE: Two different SnF2 dentifrices showed significantly reduced gingival bleeding and plaque levels relative to a Zn/arginine dentifrice.

Rapid Antigingivitis Efficacy of a Novel Stannous Fluoride Dentrifice: Results from a 12-Week Randomized Controlled Clinical Trial.

OBJECTIVE: To assess the anti-gingivitis and anti-plaque efficacy of a novel bioavailable stannous fluoride (SnF2) dentifrice to a negative control. METHODS: This was a 12-week randomized, controlled, double-blind, two-treatment, parallel group clinical study. One hundred generally healthy adults with evidence of plaque and gingivitis were enrolled into the study. Subjects were randomly assigned to one of two dentifrice treatments: (1) novel SnF2 dentifrice containing the amino acid glycine as a stabilizing chelant (Procter and Gamble) or (2) a negative control sodium monofluorophosphate dentifrice. Gingivitis was assessed using the Löe-Silness Gingivitis Index (LSGI) at baseline, Week 1, and Week 12 while plaque was evaluated according to the Turesky Modification of the Quigley-Hein Plaque Index at baseline and Week 12. RESULTS: One hundred subjects completed the trial. Subjects using the novel SnF2 dentifrice demonstrated statistically significantly fewer bleeding sites and a lower LSGI score versus those using the negative control as early as Week 1 (P less than .001). The benefit increased throughout the study, with the SnF2 dentifrice showing 33.4% fewer bleeding sites and a 16.5% lower LSGI score versus the negative control at Week 12 (P less than .001). Subjects with localized or generalized gingivitis (≥10% bleeding sites) had 6 times better odds of transitioning to generally healthy (less than 10% bleeding sites) after using the SnF2 dentifrice for 12 weeks versus the negative control. Plaque scores for the SnF2 dentifrice were also statistically significantly lower (P less than .001) than those for the negative control at Week 12. CONCLUSION: The novel SnF2 dentifrice with the amino acid glycine produced statistically significant improvements in gingival health that were seen as early as 1 week and numerically increased throughout the study.

Bioavailable gluconate chelated stannous fluoride toothpaste meta-analyses: Effects on dentine hypersensitivity and enamel erosion.

OBJECTIVES: To compare the effect of bioavailable gluconate-chelated stannous fluoride (SnF2) toothpaste with control toothpastes for treatment of dentine hypersensitivity (DH) and enamel erosion. DATA AND SOURCES: A Procter & Gamble Oral Care archive of clinical studies was reviewed from 2000 to 2020. Eligible studies were Randomised Controlled Trials (RCTs) investigating bioavailable gluconate-chelated SnF2 toothpaste efficacy compared to controls in adult participants measured following tactile (Yeaple force) and/or evaporative stimuli (Schiff score) in-vivo, duration <2 months (DH); or by erosive toothwear (profilometry) from in-situ samples, duration 10-15 days. Two authors independently assessed eligibility and resolved disagreements by discussion. A meta-analysis was undertaken and Risk of Bias (RoB) assessed using the Cochrane collaboration RoB tool for randomized parallel-group and cross-over trials. RESULTS: Fourteen RCTs (1287 participants) assessed DH relief and Six RCTs (184 participants) enamel erosion protection. For DH SnF2 toothpastes provided a 57 % (evaporative air) and 142 % (tactile) benefit versus negative controls (sodium fluoride/monofluorophosphate, 8 studies; p < 0.001). Compared to positive controls (potassium nitrate or arginine, 6 studies), a 22 % advantage (p = 0.036) was seen for evaporative air. In erosion studies, SnF2 toothpastes provided an 83 % benefit versus control toothpastes (arginine or sodium fluoride; p < 0.001) with a change (95 %CI) in average surface profilometry level (µm) of -2.02(-2.85, -1.20). CONCLUSIONS: The use of these bioavailable SnF2 toothpastes, as part of a daily oral hygiene regimen, will provide patients with enamel erosion protection, combined with alleviation of DH pain when present, improving quality of life.

Efficacy of an anhydrous stannous fluoride toothpaste for relief of dentine hypersensitivity: A randomized clinical study.

AIM: To compare efficacy of an anhydrous 0.454% w/w stannous fluoride/sodium fluoride toothpaste (Test) versus a sodium monofluorophosphate toothpaste (Negative control) and a stannous chloride/sodium fluoride toothpaste (Positive control) for dentine hypersensitivity relief after 8 weeks' twice-daily use. MATERIALS AND METHODS: In this randomized, examiner-blind, stratified, parallel study, primary and secondary efficacy variables were mean changes in Schiff score (evaporative [air] sensitivity) and tactile threshold (Yeaple probe), respectively, from baseline to Week 8 between Test (n = 62) and Negative control (n = 62). Test and Positive control (n = 61) comparisons were exploratory objectives. RESULTS: All groups significantly improved from baseline on both dentine hypersensitivity measures (p < .0001). Difference between adjusted mean changes from baseline in Schiff sensitivity scores at Week 8 for Test versus Negative control groups was 0.19 (95% CI 0.002, 0.374), in favour of the Negative control (p = .0476; 12.57% difference). Difference in tactile threshold was -7.20 g (95% CI -16.376, 1.975), and this was not statistically significant (p = .3715; -21.83% difference). Test group showed no significant difference versus Positive control for either measure. Toothpastes were generally well tolerated. CONCLUSION: While twice-daily use of Test toothpaste significantly reduced dentine hypersensitivity from baseline, there was no significant advantage over negative or positive controls. STUDY REGISTRATION: Clinicaltrials.gov; NCT03310268.

A randomized, controlled, two-month pilot trial of stannous fluoride dentifrice versus sodium fluoride dentifrice after oxalate treatment for dentinal hypersensitivity.

OBJECTIVES: To compare the effects of a stannous fluoride dentifrice and a sodium fluoride dentifrice on dentinal hypersensitivity when used with an oxalate-based regimen combining in-office and at-home treatment. MATERIALS AND METHODS: In this single-center, randomized, controlled, double-blind, pilot clinical trial, 30 subjects were professionally treated at baseline with a 3% oxalate/potassium salt solution on up to two target teeth, then randomized 1:1 to either 0.454% stannous fluoride or 0.243% sodium fluoride overlabeled dentifrice. Both groups were given 6 sensitivity strips (3.14% potassium oxalate gel) and a soft, manual toothbrush. Subjects were permitted to apply strips on up to two teeth, up to three times per tooth, at home as desired throughout the study. Dentinal sensitivity (cold air blast challenge) was assessed at baseline, immediately after post-professional treatment, and at day 60 using the Schiff scale and a Visual Analog Scale (VAS). RESULTS: Immediately after professional oxalate treatment, the overall mean Schiff and VAS score decreased 25.6% and 22.4% from baseline, respectively (p ≤ 0.001 for both). At day 60, further reductions in both mean scores were seen in both groups. There were no significant differences between the groups at day 60. All treatments were well tolerated. CONCLUSIONS: In subjects treated with oxalates for dentinal hypersensitivity, both stannous fluoride and sodium fluoride dentifrices are well tolerated, are feasible for routine use, and do not detract from the desensitizing effects of an in-office and at-home oxalate combination treatment regimen. CLINICAL RELEVANCE: Either stannous fluoride or sodium fluoride dentifrices can be recommended to dentinal hypersensitivity patients who undergo professional oxalate treatment.