Efficacy of a stannous fluoride dentifrice for relieving dentinal hypersensitivity in Chinese population: an 8-week randomized clinical trial.

OBJECTIVES: To compare the effectiveness of using a 0.454% stannous fluoride-containing dentifrice twice daily in relieving dentinal hypersensitivity (DH) in a Chinese population. MATERIALS AND METHODS: This was a single-centre, randomized, controlled, examiner-blind, three-treatment-arm, parallel-group study in participants with clinically diagnosed DH. Subjects who met inclusion criteria (n = 197) were randomly allocated into 3 groups: test group (n = 66)-using a 0.454% stannous fluoride-containing dentifrice twice daily; positive control group (n = 64)-using a 5.0% calcium sodium phosphosilicate-containing dentifrice twice daily; negative control group (n = 67)-using a 1150 ppm of NaF dentifrice twice daily. Status of DH was assessed at week 4 and week 8 by the same independent examiner. Changes from baseline in Schiff sensitivity score, tactile threshold and Dentine Hypersensitivity Experience Questionnaire (DHEQ) score were analysed using analysis of covariance models. The DHEQ evaluated subject-perceived oral health-related quality of life (OHRQoL). RESULTS: Statistically significant improvements in mean Schiff scores (p < 0.0001 for all products at Weeks 4 and 8), tactile threshold (p < 0.0001 for test and negative control at Weeks 4 and 8: Week 4 p = 0.0040 and Week 8 p < 0.0001 for positive control) and all DHEQ scores (p < 0.01 for all groups) were observed. No statistically significant differences were observed in the adjusted mean between all dentifrices at both timepoints, potentially driven by a placebo effect. Forty-two treatment-emergent adverse events (TEAEs) were reported (n = 32 subjects), with 2 serious AEs (n = 1) in the test group. TEAEs were not considered treatment-related. CONCLUSIONS: All groups demonstrated statistically significant improvements in Schiff score, tactile threshold and OHRQoL. However, due to a possible placebo effect in the negative control, there were no statistically significant differences between the dentifrices. CLINICAL RELEVANCE: This study adds to the growing research exploring why the placebo effect is a common phenomenon in DH studies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04950465.

Effects of stannous fluoride dentifrice on gingival health and oxidative stress markers: a prospective clinical trial.

BACKGROUND: Periodontal disease results in oral dysbiosis, increasing plaque virulence and oxidative stress. Stannous fluoride (SnF2) binds lipopolysaccharides to reduce plaque virulence. This study prospectively assessed SnF2 effects on oxidative stress in adults with gingivitis. METHODS: This was a 2-month, single-center, single-treatment clinical trial. Twenty "disease" (> 20 bleeding sites with ≥ 3 pockets 3 mm-4 mm deep) and 20 "healthy" (≤ 3 bleeding sites with pockets ≤ 2 mm deep) adults were enrolled. All participants were instructed to use SnF2 dentifrice twice daily for 2 months. An oral examination, Modified Gingival Index (MGI) examination and Gingival Bleeding Index (GBI) examination were conducted at baseline, 1 month and 2 months. Gingival crevicular fluid (GCF), saliva, oral lavage and supragingival plaque were collected at each visit to evaluate: Endotoxins, Protein Carbonyls, L-lactate dehydrogenase (LDH), Ferric reducing antioxidant power (FRAP), Oxidized low density lipoproteins (oxi-LDL), IL-6 and C-reactive protein (CRP). A subset-analysis examined participants considered at higher risk of cardiovascular disease. Change-from-baseline analyses within each group were of primary interest. RESULTS: The disease group showed statistically significant reductions in GBI at Month 1 (67%) and Month 2 (85%) and in MGI at Month 1 (36%) and Month 2 (51%) versus baseline (p < 0.001). At baseline, the disease group showed greater LDH in GCF and oxi-LDL levels in saliva versus the healthy group (p ≤ 0.01). Total antioxidant capacity (FRAP) in saliva increased versus baseline for the disease group at Months 1 and 2 (p < 0.05), and levels for the disease group were greater than the healthy group at both timepoints (p < 0.05). SnF2 treatment reduced endotoxins (lavage) for both disease and healthy groups at Month 2 (p ≤ 0.021) versus baseline. There was a reduction in oxidative stress markers, namely protein carbonyl in saliva, at Months 1 and 2 (p < 0.001) for both groups and a reduction in cytokine IL-6 (lavage) in the disease group at Month 2 (p = 0.005). A subset analysis of participants at higher coronary disease risk showed reductions in endotoxins in lavage, oxi-LDL, and CRP in saliva at Month 2 (p ≤ 0.04). CONCLUSION: SnF2 dentifrice use reversed gingival inflammation, suppressed endotoxins and reduced some harmful oxidant products in saliva and gingiva. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT05326373, registered on 13/04/2022.

Combined use of stannous fluoride-containing mouth rinse and toothpaste prevents enamel erosion in vitro.

OBJECTIVE: To compare the protective effect of commercial stannous-containing mouth rinses on enamel erosion in a simulated 5-day in vitro cycling model. MATERIALS AND METHODS: 81 human enamel specimens were embedded in resin blocks and divided into nine groups as follows; group 1: stannous fluoride (1000SnF2) toothpaste; groups 2,3, and 4 were the same as group 1 plus Elmex®, PerioMed™, and Meridol®, respectively, group 5: stannous fluoride (1450SnF2) toothpaste, groups 6, 7, and 8 were the same as group 5 plus Elmex®, PerioMed™, and Meridol®, respectively, group 9: negative control. An erosive challenge was induced with a 1 min hydrochloric acid (0.01 M, pH 2.2) treatment 3 times per day. Each cycle included immersing in the toothpaste slurry twice for two minutes and a one-minute rinse. The enamel slabs were immersed in artificial saliva between each erosive cycle and incubated overnight at 37 °C. Surface hardness loss and enamel loss were determined by Knoop surface hardness and non-contact profilometry, respectively. Finally, enamel surfaces were analyzed by scanning electron microscopy and X-ray energy dispersive spectroscopy (SEM/EDS). RESULTS: All three mouth rinses had similar protective effects against erosion when using adjunct with 1000 SnF2 toothpaste (p > 0.05). With 1450 SnF2 toothpaste, Elmex® presented significantly lower surface hardness loss than Meridol® (p < 0.05). The combined use of Elmex® or PerioMed™ with toothpaste provided significantly better erosion protection than toothpaste alone, either 1000 or 1450 SnF2. In addition, 1000SnF2 toothpaste adjunct with mouth rinse is comparable to 1450 SnF2 toothpaste alone in preventing enamel erosion. CONCLUSION: All three mouth rinses reduced enamel erosion. The additional use of a high concentration stannous containing mouth rinse with 1450 SnF2 toothpaste increases the protective effect against enamel erosion in vitro. CLINICAL SIGNIFICANCE: To date, no standard protocol for preventing dental erosion is available. There are three stannous-containing mouth rinses on the market; however, no study compared their efficacy or indicated whether using adjuncts with anti-erosion toothpaste provides additional benefits. This study found that adding stannous mouth rinse to twice-daily toothpaste increases erosion protection.

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.

α-SnF2 : A UV Birefringent Material with Large Birefringence and Easy Crystal Growth.

The simple binary fluoride α-SnF2 is shown to be an excellent birefringent material with outstanding birefringence, about 14 times that of MgF2 . Furthermore, it exhibits a shorter UV cutoff edge and easy crystal growth at ambient temperature compared to YVO4 and TiO2 . A novel theoretical calculation mode was established to analyze the stereochemical-activity lone-pair (SCALP) contribution to the birefringence (SCB) based on the SCALP's strength and arrangement, and it was found that the large birefringence of α-SnF2 mainly benefits from well-aligned [SnF5 ] polyhedra with a strong SCALP. The exploration of the α-SnF2 birefringent crystal points out the direction of the future search for excellent birefringent materials.

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.

Gingivitis efficacy of a 0.454% w/w stannous fluoride dentifrice: a 24-week randomized controlled trial.

BACKGROUND: Plaque-induced gingivitis can be prevented and treated with regular effective oral hygiene, principally via mechanical cleaning with regular toothbrushing. To complement the mechanical plaque removal, antimicrobial ingredients can be incorporated into dentifrices to inhibit the growth of plaque. This study aimed to evaluate and compare gingivitis and the proportion of subjects moving between gingivitis severity (< 10, > 10 < 30, > 30% bleeding sites), and plaque reduction, following twice daily use of an experimental non-aqueous 0.454% weight/weight (w/w) stannous fluoride (SnF2) dentifrice, compared to a negative control dentifrice over 12 and 24 weeks. METHOD: This was a single-center, examiner-blinded, randomized, stratified, two-treatment arm, parallel group, 24-week clinical study in healthy adult volunteers with moderate gingivitis. At baseline, after abstaining from toothbrushing overnight, subjects underwent MGI (modified gingival index), BI (bleeding index) and PI (plaque index) assessments. Eligible subjects, who met the inclusion/exclusion criteria, were stratified based on gender and baseline mean MGI score (Low ≤2.00 /High > 2.00) and randomized to treatment. Following randomization, subjects underwent a thorough dental prophylaxis and flossing. After 12 and 24 weeks of twice daily brushing with their allocated treatment, subjects returned to the site (with overnight plaque, having abstained from oral hygiene procedures for 8 h prior to visit) for MGI, BI and PI assessments. Treatment effect was evaluated by comparing the MGI, BI and PI scores. RESULTS: One hundred and twenty-nine subjects were screened; 98 subjects were randomized and 90 subjects completed the study. Statistically significant differences between treatments, in favour of the 0.454% stannous fluoride dentifrice were observed, compared to the negative control dentifrice, for all outcome measures (MGI, BI, bleeding sites and PI at weeks 12 and 24 p < 0.0001). At 24 weeks, 71% of subjects in the 0.453% SnF2 treatment group demonstrated < 10% of bleeding sites. CONCLUSION: A dentifrice containing 0.454% w/w SnF2 was shown to be superior to a standard dentifrice in controlling gingivitis and supra-gingival plaque, over a 24-week period. Over two thirds of subjects in the 0.454% SnF2 treatment group demonstrated a level of bleeding sites potentially representative of "clinical periodontal health" (< 10%) following a dental prophylaxis and 24 weeks of product use. TRIAL REGISTRATION: This study was retrospectively registered at ClinicalTrials.gov, on 11th Oct. 2019 (NCT04123665).

The effects of bioavailable gluconate chelated stannous fluoride dentifrice on gingival bleeding: Meta-analysis of eighteen randomized controlled trials.

AIM: To estimate gingivitis effects of a bioavailable gluconate chelated 0.454% stannous fluoride (SnF2 ) family of dentifrices in adult subjects versus positive (triclosan) and negative (NaF or MFP) controls when used ≤3 months. MATERIALS AND METHODS: A meta-analysis evaluated bioavailable gluconate chelated SnF2 dentifrices versus a negative or positive control for gingival bleeding. RESULTS: In 18 randomized controlled trials (RCTs) with 2,890 subjects assessing SnF2 paste versus a negative or positive control, the average number of bleeding sites was reduced by 51% and 31%, respectively. The average change (95% CI) in number of bleeding sites was -16.3 (-27.8, -4.9) versus the negative control and -3.6 (-5.4, -1.8) versus the positive control. Subjects with localized or generalized gingivitis had 3.7 times better odds (95% CI [2.8, 5.0]) of shifting to generally healthy using SnF2 versus a negative control and 2.8 times better odds (95% CI [2.1, 3.9]) of shifting to generally healthy using SnF2 versus a positive control. The individual study risk of bias was deemed to be low in all categories of bias. CONCLUSION: This meta-analysis demonstrates significant gingivitis benefits of bioavailable SnF2 dentifrices when used ≤3 months versus positive (triclosan) and negative (NaF or MFP) controls.

Is the dentifrice containing calcium silicate, sodium phosphate, and fluoride able to protect enamel against chemical mechanical wear? An in situ/ex vivo study.

OBJECTIVES: The aim of this study was to investigate the effect of a dentifrice that contains calcium silicate, sodium phosphate, and fluoride on erosive-abrasive enamel wear. MATERIAL AND METHODS: This randomized, single-blind in situ/ex vivo study was conducted with four crossover phases of 5 days (one group tested per phase). Bovine enamel blocks (n = 256) were allocated to 16 volunteers and 8 groups. The groups under study were test dentifrice, with calcium silicate, sodium phosphate, and 1450 ppm sodium monofluorophosphate; tin dentifrice, with 3500 ppm stannous chloride, 700 ppm amine fluoride, and 700 ppm sodium fluoride; conventional dentifrice, with 1450 ppm sodium monofluorophosphate; and control (deionized water). Half of the enamel blocks were subjected to erosion and the other half to erosion plus abrasion. The daily extraoral protocol consisted in four citric acid exposures (2 min) and two applications of dentifrice slurry on all blocks for 30 s; after, half of the blocks were brushed for 15 s. The response variable was enamel loss. Data were analyzed by two-way ANOVA and Fisher's test (p < 0.05). RESULTS: For erosion, the test dentifrice promoted less enamel loss than water (4.7 ± 3.1 and 5.8 ± 2.5 µm, respectively, p < 0.05), and did not differ from tin (4.8 ± 2.5 µm) and conventional (4.8 ± 1.4 µm) dentifrices (p > 0.05). However, the test dentifrice (7.7 ± 3.8 µm) promoted higher wear after erosive plus abrasive procedures than tin (5.4 ± 1.5 µm) and conventional (6.2 ± 1.7 µm, p < 0.05) dentifrices, and did not differ from water (6.9 ± 2.0 µm). CONCLUSIONS: The investigated dentifrice reduced enamel loss against acid challenge but had no effect against acid and brushing challenge. CLINICAL RELEVANCE: Little is known regarding the preventive effect of dentifrices indicated for dental erosion. The tested anti-erosive dentifrice was unable to protect enamel when erosion was associated to toothbrushing abrasion.

Randomized in situ clinical trial evaluating erosion protection efficacy of a 0.454% stannous fluoride dentifrice.

OBJECTIVES: To assess the protective effects of a 0.454% stabilized stannous fluoride dentifrice and a marketed triclosan dentifrice against enamel erosion in a 10-day in situ model. METHODS: This was a double-blind, randomized, 2-treatment, 4-period, crossover in situ trial involving healthy adult participants. Participants were randomized to a treatment sequence involving the following products: a highly bioavailable 0.454% stannous fluoride dentifrice (Procter & Gamble) and a marketed dentifrice control containing 0.24% sodium fluoride and 0.3% triclosan (Colgate-Palmolive). Each study period took place over 10 days. Participants wore an intra-oral appliance retaining two polished human enamel samples for 6 hours per day. Two times per day they swished with the assigned dentifrice slurry and four times per day they swished with 250 mL of orange juice (25 mL per minute) over a 10-minute period. Contact profilometry measurements were made for each sample at baseline and day 10 to determine surface change. RESULTS: Thirty-six participants were enrolled and 33 completed the study (mean age = 40.5 years). The stannous fluoride dentifrice demonstrated 93.5% less enamel loss than the NaF/triclosan dentifrice (P < 0.001) at Day 10, with median enamel loss of 0.097 µm and 1.495 µm, respectively. Both products were well tolerated. CONCLUSION: The stannous fluoride dentifrice demonstrated significantly greater erosion protection efficacy relative to the NaF/triclosan dentifrice in this randomized in situ clinical trial.

Clinical Effects of Stabilized Stannous Fluoride Dentifrice in Reducing Plaque Microbial Virulence II: Metabonomic Changes.

OBJECTIVES: The clinical effects of stannous fluoride (SnF2) dentifrice in reducing symptoms of gingivitis and reducing the virulence of subgingival plaque through suppression of activation of gene expression in toll receptor based reporter cells were previously reported. This study expanded analysis of the clinical study to include evaluation of dentifrice effects on salivary metabolites using 1H Nuclear Magnetic Resonance (1H NMR) systems biology-based metabonomics. METHODS: The clinical design was reported previously (J Clin Dent2017;28:16-26). Participants included a cohort exhibiting high and low levels of gingival disease as presented at initiation of the study. Participants provided morning lavage saliva samples at baseline. Following this, participants were provided with a hygiene intervention, including a stabilized SnF2 dentifrice and a new soft bristle manual toothbrush. Following two and four weeks of assigned dentifrice use, participants again collected morning lavage saliva samples. Samples were analyzed by 1HNMR spectroscopy on a Bruker 600MHz NMR spectrometer. System-wide analyses were carried out by partial least squared (PLS) comparisons of aggregate spectra, and discrete metabolites with established spectral signatures were likewise directly compared. RESULTS: PLS analysis showed significant differences in saliva composition for saliva collected from high bleeding and low bleeding cohorts. Clear shifts in saliva composition were observed in system-wide PLS analysis following intervention of SnF2 dentifrice for both cohorts. A number of discrete spectral changes were consistently observed with SnF2 dentifrice intervention, most notably including reductions in propionic acid and butyric acid, key short chain fatty acids associated with anaerobic metabolism in dental plaques. CONCLUSIONS: These results collectively demonstrate that SnF2 dentifrice treatment was associated with broad scale modifications in saliva composition following intervention in both high and low diseased cohorts. Changes in overall salivary composition and specific reductions in saliva concentrations of propionic and butyric acid reductions occurred coincident with clinical improvements in gingivitis and gingival bleeding. These results provide support for the hypothesis that the effectiveness of SnF2 dentifrice in improving gingival health is associated with a modification of microbiome metabolism, including suppression of short chain fatty acid metabolites.

A Randomized Controlled Clinical Trial to Evaluate the Efficacy of an Oscillating-Rotating Electric Toothbrush, a Stannous Fluoride Dentifrice, and Floss on Gingivitis.

OBJECTIVES: To evaluate the gingival health efficacy of an oscillating-rotating electric toothbrush, a stannous fluoride dentifrice, and dental floss in adults with mild-to-moderate gingivitis. METHODS: This was a single-center, randomized, controlled, examiner-blind, two-treatment, eight-week parallel group study in adults with at least 20 gingival bleeding sites. Eligible subjects were randomized equally to one of two groups: experimental oral hygiene group that included an Oral-B® oscillating-rotating electric toothbrush with round brush head (D20/EB20), Crest® stabilized stannous fluoride dentifrice (SnF2 1100 ppm F, NaF 350 ppm F), and Oral-B® Glide® floss; or regular oral hygiene control group that included a regular manual toothbrush (Oral-B® Indicator 35) and Crest® anti-cavity sodium fluoride dentifrice (NaF 1450 ppm F). Subjects followed manufacturer's instructions and used their assigned products over an eight-week period. Gingival health was measured at baseline, Week 4, and Week 8 using three assessments: Gingival Bleeding Index (GBI), number of bleeding sites, and Modified Gingival Index (MGI). Analysis of Covariance was used to compare gingival health between treatment groups. RESULTS: One hundred and twenty subjects, mean age 44 years (range: 21 to 74 years), were assessed at baseline (60 per group); 113 subjects (57 in control group, 56 in experimental group) completed the study with fully evaluable data. At baseline, the groups were balanced; overall means were 0.41 for GBI, 51.7 for bleeding sites, and 1.44 for MGI. Only the experimental group showed statistically significant reductions from baseline (p < 0.0001) for all three gingivitis assessments at both Weeks 4 and 8. At these time points, better gingival health for the experimental group was seen as significantly lower adjusted mean scores versus the control group (p < 0.0001) for all three assessments. Reductions in favor of the experimental group at Weeks 4 and 8, respectively, were 51% and 45% for GBI, 46% and 40% for number of bleeding sites, and 37% and 20% for MGI. The study treatments were well tolerated. CONCLUSIONS: Over an eight-week period, an oral hygiene routine with an oscillating-rotating electric toothbrush, stannous fluoride dentifrice, and floss significantly improved gingivitis compared to regular hygiene with a manual toothbrush and an anti-cavity sodium fluoride dentifrice.

Gingivitis Models - Relevant Approaches to Assess Oral Hygiene Products.

OBJECTIVES: To review the application of gingivitis prevention and treatment models to assess the efficacy of mechanical and chemotherapeutic oral hygiene interventions following shorter- and longer-term use. METHODS: Representative published clinical trials evaluating the shorter- and longer-term anti-gingivitis efficacy of stannous fluoride dentifrice, cetylpyridinium chloride (CPC) rinse, and oscillating-rotating (O-R) electric rechargeable toothbrushes were reviewed. Key gingivitis indices, including the Löe-Silness Gingival Index (LS), Lobene Modified Gingival Index (MGI), Gingival Bleeding Index (GBI), Papillary Bleeding Index (PIBI), and the Mazza modification of the PIBI (Mazza GI), were evaluated for their relative validity and sensitivity in evaluating prevention and treatment outcomes. RESULTS: Twenty clinical trials were evaluated, including 11 treatment studies and 9 prevention trials. Collectively, the findings demonstrated the efficacy of stabilized stannous fluoride toothpaste, CPC rinses, and O-R electric toothbrushes in improving gingival health both in longer-term prevention and shorter-term treatment models. The studies employed various frequently used gingivitis indices. The indices were sufficiently sensitive to elucidate treatment differences. CONCLUSIONS: Based on the results of this review, gingivitis prevention and treatment studies are valid approaches to show treatment effects, and their utilization is dependent upon whether the intention is to evaluate "reducing the onset of gingivitis" or "reducing the severity of existing gingivitis." Various indices, including the LS, MGI, GBI, PIBI, and Mazza GI indices, provide valid measurements for evaluating gingivitis in treatment and prevention models. Shorter-term treatment models allow for efficient efficacy evaluation in clinically relevant populations with existing disease.

Effects of dentifrices differing in fluoride compounds on artificial enamel caries lesions in vitro.

The aim of this study was to compare the caries-preventive effect of a stabilized stannous fluoride/sodium fluoride dentifrice containing sodium hexametaphosphate with those of a regular, solely sodium fluoride-containing and amine fluoride-containing dentifrice on pre-demineralized bovine enamel specimens using a pH-cycling model. Bovine enamel specimens with two artificial lesions each were prepared. Baseline mineral loss of both lesions was analyzed using transversal microradiography (TMR). Eighty-five specimens with a mean (SD) baseline mineral loss of 3393 (683) vol% × µm were selected and randomly allocated to five groups (n = 13/15). Treatments during pH-cycling (28 days and 2 × 20 min demineralization/day) were: brushing twice daily with slurries of AmF (1400 ppm F-), NaF (1450 ppm F-), SnF2/NaF (1100 ppm F-/350 ppm F-), and fluoride-free (FF) dentifrices or they were immersed in distilled water and remained unbrushed (NB). Subsequently, from each specimen one lesion was covered with acid-resistant varnish, while the remaining lesion was demineralized for another 14 days. Differences in integrated mineral loss (∆∆Z) were calculated between values before and after pH-cycling (∆∆Z E1) as well as before pH-cycling and after second demineralization (∆∆Z E2) using TMR. Treatments AmF and NaF induced a significantly higher mineral gain (∆∆Z E1/∆∆Z E2) compared to treatments FF and NB (p < 0.05; ANOVA test). Except for treatments AmF and NaF no significant differences in mineral loss between before and after pH-cycling could be observed (p < 0.05; t test) [∆∆Z E1: AmF:1563 (767); NaF:1222 (1246); SnF2/NaF:258 (1259); FF:-52 (1223); NB:-151 (834)]. Both dentifrices with either AmF or NaF promoted remineralization, whereas SnF2/NaF dentifrice did not promote remineralization in a biofilm-free pH-cycling model.

Assessment of the Effects of a Novel Stabilized Stannous Fluoride Dentifrice on Gingivitis in a Two-Month Positive-Controlled Clinical Study.

OBJECTIVES: The aim of this study was to compare the antibleeding/antigingivitis effectiveness of a newly formulated 0.454% stabilized stannous fluoride dentifrice and a marketed positive control triclosan-containing dentifrice in adults with mild-to-moderate gingivitis. METHODS: This single-center, two-month, randomized and controlled, double-blind, parallel group clinical trial involved adults with preexisting mild-to-moderate gingivitis. Baseline bleeding and gingivitis levels were assessed with the Gingival Bleeding Index (GBI) and Lobene Modified Gingival Index (MGI). Subjects were randomly assigned to either a new smooth formula 0.454% stabilized stannous fluoride test dentifrice (Crest® Pro-Health™) or a commercially available positive control 0.30% triclosan dentifrice (Colgate® Total®). Subjects brushed with their assigned dentifrice at home according to the manufacturer's instructions. At Month 2, subjects were re-evaluated for bleeding and gingivitis as at Baseline, with MGI and GBI evaluations. RESULTS: Of the 200 subjects randomized to treatment, 197 completed the study and had fully evaluable data. At Month 2, both the stannous fluoride and triclosan control dentifrices produced statistically significant reductions (p < 0.0001) in the mean number of bleeding sites, MGI, and GBI compared to Baseline. Use of this 0.454% stannous fluoride dentifrice resulted in 22% fewer bleeding sites versus the positive control triclosan dentifrice (p < 0.0001). Similarly, after two months of brushing, the stannous fluoride dentifrice group showed statistically significant lower mean MGI and GBI scores than subjects using the triclosan positive control dentifrice (p < 0.0001). Both dentifrices were well-tolerated. CONCLUSIONS: Subjects brushing with a newly formulated stannous fluoride dentifrice had statistically significantly fewer bleeding sites and less gingivitis than those using a positive control triclosan dentifrice after two months.

A Randomized Clinical Trial to Measure the Erosion Protection Benefits of a Novel Stabilized Stannous Fluoride Dentifrice versus a Control Dentifrice.

OBJECTIVES: The aim of this investigation was to assess the erosion protection ability of a novel stabilized stannous fluoride (SnF2) dentifrice and a control sodium fluoride dentifrice (NaF) using a well-credentialed human in situ model. METHODS: A novel smooth texture 0.454% stabilized SnF2 dentifrice (Crest® Pro-Health™ smooth formula) and a 0.23% NaF marketed control dentifrice with 5% potassium nitrate (Sensodyne® Pronamel®) were compared in a 10-day, single center, randomized, controlled, double-blind, two-treatment, three-period crossover in situ clinical trial. Subjects wore a mandibular buccal appliance fitted with eight enamel specimens for approximately six hours over the course of each study day. Twice daily, subjects brushed the lingual surfaces of their teeth for 30 seconds while wearing the appliance, then swished with their assigned treatment toothpaste slurry for 90 seconds under the supervision of clinic staff. Erosive acid challenges with a citric acid-containing beverage (commercial orange juice) were done four times each day. RESULTS: The SnF2 dentifrice provided 26.9% greater erosion protection relative to the NaF dentifrice at Day 10 (p < 0.03). Adjusted means of enamel surface loss at Day 10 were 9.117 µm for the SnF2 dentifrice and 12.471 µm for the NaF marketed control. CONCLUSIONS: These results demonstrate the stabilized SnF2 dentifrice offered greater protection over the NaF dentifrice against the initiation and progression of dental erosion.

Comparative Antiplaque Effect of Two Antimicrobial Dentifrices: Laboratory and Clinical Evaluations.

OBJECTIVES: To compare the effect of a stannous fluoride dentifrice versus a triclosan-containing dentifrice on the reduction of plaque using in vitro and clinical models. METHODS: Both investigations evaluated a novel 0.454% stabilized stannous fluoride dentifrice (Crest® Pro-Health™ smooth formula) versus a sodium fluoride/triclosan positive control dentifrice (Colgate® Total®). The in vitro evaluation utilized the Plaque Glycolysis and Regrowth Model (PGRM), wherein the metabolic effects (acid production/glycolysis inhibition) of the dentifrices were assessed on plaque biofilms grown on glass rods after three days growth and a single dentifrice treatment. Treatments were evaluated via analysis of variance, Student's t-test. The clinical trial was a four-week, single-center, randomized and controlled, double-blind, parallel group study, where 120 adults were randomized to one of the two dentifrices for use at home according to manufacturer's instructions. Plaque was evaluated at baseline and Week 4 with the Rustogi Modified Navy Plaque Index (RMNPI). Statistical analyses were via analysis of covariance. RESULTS: In vitro PGRM: The stannous fluoride dentifrice provided 43.3% glycolysis inhibition compared to 27.5% for the triclosan control, and the pH decrease associated with acid production was significantly less for stannous fluoride (0.87) versus triclosan (1.11); p < 0.05. Clinical trial: One hundred eighteen (118) subjects completed the study with fully evaluable data. Both dentifrice groups demonstrated statistically significant (p < 0.0001) reductions in plaque at Week 4 compared with baseline, with the stannous fluoride dentifrice producing a significantly lower adjusted mean Week 4 plaque score (p < 0.0001) versus the triclosan positive control for whole mouth plaque (23.1% lower) and interproximal plaque (43.5% lower). Both dentifrices were well-tolerated. CONCLUSIONS: The stabilized stannous fluoride dentifrice provided statistically significant reductions in plaque glycolysis in vitro and plaque growth in vivo compared to the triclosan dentifrice. Results for both studies were consistent.

In Vitro and In Vivo Evaluations of the Anticalculus Effect of a Novel Stabilized Stannous Fluoride Dentifrice.

OBJECTIVES: To evaluate the effect of a novel stannous fluoride dentifrice with zinc citrate on calculus inhibition using both in vitro and clinical models. METHODS: Each investigation tested a novel stabilized 0.454% stannous fluoride dentifrice with zinc citrate as an anticalculus agent (Crest® Pro-Health™ smooth formula) compared to a negative control fluoride dentifrice. The in vitro study used the modified Plaque Growth and Mineralization Model (mPGM). Plaque biofilms were prepared and mineralized by alternate immersion of glass rods in human saliva and artificial mineralization solution. Treatments of 25% w/w dentifrice/water slurries were carried out for 60 seconds daily for 6 days, between saliva and mineralization solution immersions. Plaque calcium levels were determined by digestion and inductively coupled plasma optical emission spectroscopy. Student's t-test (p < 0.05) was used for statistical analysis. The clinical study was a parallel group, double-blind, randomized, and controlled trial. Following a dental prophylaxis, subjects entered a two-month run-in phase. At the end, they received a Volpe-Manhold Index (V-MI) calculus examination. Eighty (80) qualified subjects who had formed at least 9 mm of calculus on the linguals of the mandibular anterior teeth were re-prophied and randomly assigned to either the stannous fluoride dentifrice or the negative control. Subjects brushed twice daily, unsupervised, during the three-month test period, returning at Weeks 6 and 12 for safety and V-MI examinations. Statistical analyses were via ANCOVA. RESULTS: In vitro mPGM: The stabilized stannous fluoride dentifrice showed 20% less in vitro tartar formation, measured as calcium accumulation normalized by biofilm mass, versus the negative control (106.95 versus 133.04 µg Ca/mg biofilm, respectively, p < 0.05). Clinical Trial: Seventy-eight (78) subjects completed with fully evaluable data. The stannous fluoride dentifrice group had 15.1% less adjusted mean calculus at Week 6 compared to the negative control group (p = 0.05) and 21.7% less calculus at Week 12 (p < 0.01). Both dentifrices were well-tolerated. CONCLUSIONS: The stannous fluoride dentifrice produced significant anticalculus benefits in vitro and in a clinical trial compared to a negative control.