To confirm anti-sensitivity efficacy of a new anhydrous 0.454

Daily-use fluoride products are first-line protection against enamel wear from dietary-acid exposure (DAE). This study aimed to understand effects of fluoride concentration, fluoride salt, product form and ingredients in daily-use products on remineralisation and demineralisation, via network meta-analysis (NMA) of 14 studies using one well-established in-situ model. Remineralisation (surface-microhardness recovery, SHMR) after treatment, and protection against subsequent demineralisation (acid-resistance ratio, ARR) were measured. Healthy participants, wearing intra-oral palatal appliances holding enamel specimens eroded with standardised DAE, used test products once. Enamel hardness was assessed (Knoop microhardness probe) pre-DAE; post-DAE; after 4 h intra-oral remineralisation; and after post-remineralisation DAE. NMA was performed using a mixed-models approach on subject-level data to estimate and compare means. There was a dose-response for fluoride ion in toothpastes (0-1426ppm F; p < 0.001 for SMHR and ARR). One toothpaste (silica-based, 1150ppm F as NaF) showed a benefit for SMHR versus placebo [mean(standard error)]: 8.8

Objectives To determine the prevalence and associated risk indicators for dentine hypersensitivity (DH), erosive tooth wear (ETW), gingival recession (GR), and gingival inflammation (bleeding on probing, BOP), with clinical and questionnaire data from seven European countries. Methods A cross-sectional, observational, seven-European country, epidemiological study in systemically healthy adults. Participants completed a questionnaire regarding oral hygiene, diet and lifestyle factors. A clinical examination, by calibrated examiners, measured DH (Schiff; participant yes/no), ETW (basic erosive tooth wear examination, BEWE), GR (mm), and BOP (yes/no). Results 3551 participants completed the study, mean age 44±17.4, 43.6% male, 26.1% rural dwellers. DH (Schiff ≥1) was seen in 75.9% of participants, ETW (BEWE ≥1) in 97.6%, GR (≥1 mm) in 87.9%. 65.7% participants had BOP≥10% sites, 34.3% BOP<10% with probing depths ≤3 mm. DH, ETW, GR and BOP increased markedly during young adult life. Thereafter, GR and ETW continued to increase, DH declined after around age 38-47, and BOP plateaued after age 48. DH was significantly associated with ETW (p<0.001) and GR (p<0.01); GR was significantly associated with BOP on lingual surfaces (p=0.017). There were significant associations between increased full mouth BOP≥10% and reduced brushing duration and exercise frequency (p<0.001); increased DH and heartburn (p<0.001); decreased DH (p<0.001), ETW (p<0.001) and BOP≥10% (p=0.002) with powered toothbrush use. Conclusions Prevalence of oral conditions assessed was high, greater than in the majority of the GR, DH and ETW literature. Periodontal health was seen in a third of sampled individuals. All these conditions varied markedly by country and age. Clinical Significance Oral diseases and conditions were highly prevalent throughout the seven European countries investigated. For the majority, these conditions are eminently preventable and treatable by changing behaviours. Upstream policy changes are needed to address these health challenges, to raise awareness and to empower individuals with oral health education and support.

Purpose: A novel anhydrous toothpaste formulation has been developed containing the anti-dentinal hypersensitivity (DH) ingredient stannous fluoride (SnF2). Materials and Methods: This randomised, controlled, examiner-blind, parallel-group, stratified (by baseline Schiff sensitivity score) study compared efficacy of an experimental 'Test' toothpaste (n = 67) containing 0.454% SnF2, 0.072% sodium fluoride and 5% sodium tripolyphosphate (all percentages w/w) with a negative 'Control' 0.76% sodium monofluorophosphate toothpaste (n = 68) in relieving DH in healthy Chinese adults. After 4-6 weeks acclimatisation, DH was assessed at baseline and following 4 and 8 weeks' twice-daily brushing by response to evaporative (air) (Schiff sensitivity score) and tactile (Yeaple probe) stimuli. An analysis of covariance model was used (factor: treatment group; covariate: baseline Schiff sensitivity score). Results: Both Test and Control toothpastes statistically significantly reduced Schiff sensitivity score from baseline after 8 weeks' use; the Test toothpaste also statistically significantly reduced the score after 4 weeks' use (all p < 0.001). The Test toothpaste reduction was statistically significantly superior to the Control toothpaste reduction at both timepoints (p < 0.001). Percentage differences in treatment effects between Test and Control groups were 24.1% at 4 weeks and 31.7% at 8 weeks. Tactile threshold scores for both treatments statistically significantly increased from baseline at both timepoints (all p < 0.001); however, there were no statistically significant differences between Test and Control groups. Both toothpastes were well-tolerated with no adverse events reported. Conclusion: The Test toothpaste containing 0.454% SnF2 reduced DH statistically significantly more than the Control as evaluated by the Schiff sensitivity score, but not by tactile threshold.

Abstract Objectives: To evaluate a 0.454% stannous fluoride/5% sodium tripolyphosphate (STP) toothpaste’s ability to provide relief from dentinal hypersensitivity (DH) applied using ‘focused brushing.’ Materials and methods: In two randomised, examiner-blind, parallel-group studies, a SnF2/STP toothpaste was applied by brushing two selected sensitive teeth before 1 min whole-mouth brushing, compared to 1 min whole-mouth brushing only, with a negative control toothpaste. DH was assessed via evaporative (air) (Schiff scale) and tactile (Yeaple probe) stimuli after 7 and 14 d of twice-daily brushing. Results: In total, 141 (Study 1)/142 (Study 2) participants were randomised. In Study 1, the test treatment significantly reduced DH at 7/14 d versus baseline (7/14 d Schiff difference: −0.74 [−0.84,−0.65]/−1.39 [−1.54,−1.23]; tactile: 6.00 [4.88,7.13]/15.30 [13.34,17.26]); whereas the Control treatment did not (7/14 d Schiff difference −0.03 [−0.13,0.06]/−0.10 [−0.25,0.06]; tactile: 0.77 [−0.36,1.90]/0.77 [−1.20,2.74]). Differences between Test and Control were statistically significant (p < 0.0001 all cases). In Study 2, both treatments reduced DH compared to baseline by both measures, but there were no significant between-treatment differences. Toothpastes were generally well-tolerated. Discussion and conclusions: Previous studies and Study 1 support SnF2/5% STP toothpaste efficacy; Study 2 results may have been influenced by placebo/Hawthorne effects. DH study design needs to, where possible, negate such effects.

Fluoride is a key dentifrice ingredient for mitigating dental erosion and promoting remineralisation in tooth enamel. A dentifrice formulation (NaF/CL ‐ where C = Copolymer, L = Lactate), optimised for fluoride delivery, containing sodium fluoride, polyvinylmethylether–maleic anhydride (PVM/MA) copolymer and lactate ion at controlled pH of 6.2 is compared with six commercial dentifrices from European and US regulatory regions. The in vitro study utilised white light interferometry (WLI) and dynamic secondary ion mass spectrometry (DSIMS) to assess dental erosion resistance and remineralisation potential of the dentifrices. For WLI, polished enamel samples were immersed in dentifrice slurry (1:3 wt./wt. in artificial saliva, 2 min), brushed, washed in deionised water, acid challenged (1% citric acid, pH 3.8, 5 min), washed and air dried. Surface roughness and bulk tissue loss were measured. DSIMS samples for fluoride uptake were acid challenged (1% citric acid, pH 3.8, 5 min), rinsed, immersed in dentifrice slurry (1:3 wt./wt. in artificial saliva, 2 min), washed and air dried. DSIMS samples for 44Ca uptake were prepared similarly but with 44Ca‐doped artificial saliva. The NaF/CL dentifrice provided highest protection against dental erosion, with highest fluoride and 44Ca uptake in all treatment groups (n = 5 per group). Dentifrices containing other fluoride salts and/or ingredients known to inhibit fluoride uptake (e.g., polyphosphates, sodium lauryl sulfate), performed significantly worse.

Abstract Background A novel sodium fluoride toothpaste containing lactate ion and polyvinylmethylether-maleic anhydride has been developed to promote enamel remineralisation and resistance to demineralisation. In this in situ study, we compared this toothpaste (‘Test’) with a stannous fluoride-zinc citrate (SnF2-Zn) toothpaste (‘Reference’) (both 1100–1150 ppm fluoride) and a fluoride-free toothpaste (‘Placebo’) using an enamel dental erosion-rehardening model. Methods In each phase of this randomised, investigator-blind, crossover study, participants wore palatal appliances holding bovine enamel specimens with erosive lesions. They brushed their natural teeth with either the Test, Reference or Placebo toothpastes, then swished the resultant slurry. Specimens were removed at 2 h and 4 h post-brushing and exposed to an in vitro acid challenge. Surface microhardness was measured at each stage; enamel fluoride uptake was measured after in situ rehardening. Surface microhardness recovery, relative erosion resistance, enamel fluoride uptake and acid resistance ratio were calculated at both timepoints. Results Sixty two randomised participants completed the study. Test toothpaste treatment yielded significantly greater surface microhardness recovery, relative erosion resistance and enamel fluoride uptake values than either Reference or Placebo toothpastes after 2 and 4 h. The acid resistance ratio value for Test toothpaste was significantly greater than either of the other treatments after 2 h; after 4 h, it was significantly greater versus Placebo only. No treatment-related adverse events were reported. Conclusions In this in situ model, the novel-formulation sodium fluoride toothpaste enhanced enamel rehardening and overall protection against demineralisation compared with a fluoride-free toothpaste and a marketed SnF2-Zn toothpaste. Trial registration ClinicalTrials.gov ; NCT03296072; registered September 28, 2017.

Dentine hypersensitivity (DH) can occur after gum recession or enamel loss and may impact quality of life. Treatments include toothpastes that decrease DH by occluding dentine tubules. One effective occluding ingredient used in toothpastes is stannous fluoride (SnF2), but this can be unstable in aqueous formulation. These three studies aimed to characterise the short-term effects of an experimental, anhydrous SnF2 dentifrice on DH. Three examiner-blind, parallel-group studies evaluated DH in participants with the condition after a single brushing and after 3d brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste (Test) or a toothpaste containing 0.76% sodium monofluorophosphate (Control). Test treatment participants brushed two pre-identified sensitive teeth first, then their remaining dentition for ≥1 min (‘focused brushing’). Control treatment participants brushed their whole dentition for ≥1 min. DH was measured after single brushing and after 3d twice-daily use, via evaporative (air) (Schiff Sensitivity Scale) and tactile (Yeaple probe) stimuli and analysed using an ANCOVA model. In all studies, after 3d treatment, the Test toothpaste/brushing regimen significantly reduced DH compared to the Control regimen by both evaporative and tactile stimuli assessment (p < 0.0001 for all). The Test regimen also significantly reduced DH from baseline at both time-points by both measures in all studies (p < 0.0001 for all). Mean Schiff sensitivity score differences (95% confidence intervals) between Test and Control regimens after 3d were: Study 1: − 0.45 (− 0.577, − 0.319); Study 2: − 0.40 (− 0.505, − 0.300); Study 3: − 1.31 (− 1.500, − 1.128). Mean tactile score differences were: Study 1: 11.30 (7.927, 14.662); Study 2: 3.57 (2.531, 4.614); Study 3: 24.54 (20.349, 28.736). After single use, in Studies 2 and 3, the Test toothpaste/brushing regimen significantly reduced DH versus Control by both measures (p < 0.001 for all); in Study 1, treatment differences were not significant. Toothpastes were generally well-tolerated. Taken together, these studies indicated focused brushing with an experimental anhydrous 0.454% SnF2/polyphosphate toothpaste reduces DH compared to brushing with a conventional toothpaste after single use, with greater reduction after 3d. Registrations at ClinicalTrials.gov : Study 1: NCT02832375 (registered 26.July.2016); Study 2: NCT02731833 (registered 26.April.2016); Study 3: NCT02923895 (registered 5.October.2016).

AbstractAimTo evaluate effects of a 0.454% stannous fluoride test toothpaste on dentine hypersensitivity (DH) applied by fingertip, then 3 days’ brushing, versus a sodium monofluorophosphate‐based control.Materials and MethodsIn three randomized clinical studies, DH was assessed using evaporative (Schiff scale) and tactile (Yeaple probe) stimuli. Participants applied toothpaste to two sensitive teeth by fingertip (60 s each); DH was re‐assessed, prior to brushing. Test treatment participants brushed their sensitive teeth, with all participants then brushing all teeth for ≥60 s, twice daily for 3 days. DH was re‐assessed. Data were analysed by study and then pooled.ResultsIn two studies, test treatment significantly reduced DH versus control treatment after fingertip application and 3 days’ brushing (both measures). In one study, both treatments significantly reduced DH without between‐treatment differences. Mean Schiff differences (95% confidence intervals) for fingertip/3d were as follows: Study 1: −0.09 (−0.280, 0.092)/ −0.18 (−0.442, 0.072); Study 2: −0.72 (−0.839, −0.610)/ −1.02 (−1.150, −0.882); and Study 3: −0.26 (−0.387, −0.123)/ −0.92 (−1.055, −0.793). Pooled analysis indicated test treatment significantly reduced DH versus control (both timepoints, both measures). Toothpastes were generally well‐tolerated.ConclusionStudies indicated that single, fingertip application of a SnF2 toothpaste reduced DH versus a control. DH relief increased over 3 days.

AbstractObjectivesPhytate is an organic, cyclic polyphosphate analogous to linear condensed polyphosphates used as stain removal agents. This study investigated stain removal efficacy of an experimental sodium phytate‐containing dentifrice compared to a reference dentifrice.MethodsAn experimental, moderate abrasivity (relative dentine abrasivity [RDA] ∼130) antisensitivity fluoride dentifrice containing sodium phytate (0.85% w/w as the hexasodium salt) (n = 111) was compared to a reference, marketed, low‐abrasivity (RDA ∼ 43), anti‐sensitivity fluoride dentifrice (n = 113), both containing 1150 ppm fluoride as sodium fluoride. Primary efficacy variables were between‐treatment differences in extrinsic dental stain of anterior teeth after 6 and 12 weeks' twice‐daily use, using Lobene stain index (MacPherson modification, MLSI) mean area (A) and intensity (I) scores. Comparisons included whole‐tooth and hard‐to‐reach areas (gingival, interproximal, body of lingual).ResultsAt both 6‐ and 12‐week timepoints, MLSI (A × I) scores for total area and hard‐to‐reach areas for the experimental dentifrice were statistically significantly lower than baseline (P < .0001 for all). This was demonstrated for the reference dentifrice at 6 weeks only, for total, interproximal (P < .0001 for both), and body of lingual (P = .0395) scores. Compared with the reference, the experimental dentifrice had statistically significantly lower MLSI scores at both 6 and 12 weeks for all outcome variables including both total MLSI (A × I) and hard‐to reach areas (P < .0001 in all cases). Products were generally well‐tolerated.ConclusionsDifferences between treatments were considered clinically differentiable. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation.Clinical SignificanceFollowing 6 and 12 weeks brushing, clinically differentiable differences were shown in stain index scores with an experimental dentifrice containing sodium phytate compared to a reference dentifrice without sodium phytate. Sodium phytate may therefore be a suitable additive ingredient to improve tooth stain control performance within an otherwise conventional dentifrice formulation.

ObjectivesTo evaluate the ability of a modified in situ model to differentiate dentinal tubule occlusion properties of toothpaste formulations over 10 days of treatment.MethodsThis was a single-centre, three-treatment period, crossover, randomised, single-blind study with healthy participants wearing two lower oral appliances, each retaining four dentine samples, for 10 treatment days during each period of the study. Samples were power-brushed ex vivo twice on each treatment day with a Test toothpaste containing 0.454% stannous fluoride, a Control fluoride toothpaste containing 0.76% sodium monofluorophosphate, or mineral water. Dentine samples were subjected to in situ acid challenge (orange juice) on Days 9 and 10. Scanning electron microscopy images obtained at baseline and after 1, 4, 8 and 10 days of treatment were graded for degree of surface coverage by four calibrated examiners; the primary study endpoint was Day 8.ResultsAfter 4, but not 8, days’ treatment, the degree of tubule occlusion increased in the dentine samples treated with the Test or Control toothpastes compared with the water-treated samples (p < 0.01 and p < 0.05, respectively). Following the acid challenge (Day 10), there was a statistically significantly greater degree of occlusion in the Test toothpaste-treated dentine samples compared with those treated with water (p < 0.01). No other comparisons were statistically significant. All study treatments were generally well-tolerated.ConclusionsThis modified in situ model was unable to demonstrate statistically significant between-treatment differences in dentinal tubule occlusion after 8 days. Conversely, there are recognised developments that could be made to better identify product differences. Clinicaltrials.gov: NCT02768194.Clinical significanceDentine hypersensitivity can be managed through brushing with stannous fluoride toothpastes, which occlude patent dentine tubules. Clinical studies measure pain but in situ models are needed to demonstrate occlusion intra-orally. However, this study did not demonstrate superior occlusion with stannous toothpaste; further methodological development is required to investigate its mode of action.

The objective of this work was to evaluate effects of a dentifrice containing sodium fluoride (1150 ppm F) and the organic polyphosphate phytate (0.85% w/w of the hexa-sodium salt) on in situ remineralisation of early enamel erosive lesions and resistance to subsequent demineralisation. Subjects (n = 62) wore palatal appliances holding eight bovine enamel specimens with pre-formed erosive lesions. They brushed their natural teeth with the phytate test dentifrice (TD); a positive control dentifrice (PC, 1150 ppm fluoride as NaF); a reference dentifrice (RD, disodium pyrophosphate + 1100 ppm fluoride as NaF) or a negative control dentifrice (NC, fluoride-free) in a randomised, double-blind, crossover design. Specimens were removed at 2, 4 and 8 h post-brushing and exposed to an ex vivo acid challenge. Surface microhardness (Knoop) was measured at each stage. The primary efficacy variable was relative erosion resistance (RER); other variables included the surface microhardness recovery (SMHR), acid resistance ratio (ARR) and enamel fluoride uptake (EFU). After 4 h, the results for RER, ARR and EFU were in the order PC > TD = RD > NC with PC > TD = RD = NC for SMHR. Results at 2 and 8 h were generally consistent with the 4 h data. Mineralisation progressed over time. Dentifrices were generally well-tolerated. In this in situ model, addition of phytate or pyrophosphate to a fluoride dentifrice inhibited the remineralising effect of fluoride. Both formulations still delivered fluoride to the enamel and inhibited demineralisation, albeit to a lesser extent than a polyphosphate-free dentifrice. Addition of phytate or pyrophosphate to a fluoride dentifrice may reduce its net anti-erosive properties.

This study aimed to determine the effect of zinc ions and F concentration in a dentifrice on remineralization of early caries lesions in situ and on resistance to subsequent demineralization. This was a single-center, 6-period, 6-product, blinded (examiner, subject, analyst), randomized (n = 62), crossover study. Products (all NaF) were: 0, 250, 1,150 and 1,426 ppm F (dose-response controls), “Zn-A” (0.3% ZnCl2, 1,426 ppm F), and “Zn-B” (as Zn-A, with high-foaming surfactants) in a conventional silica base. Subjects wore palatal appliances holding partially demineralized bovine enamel specimens. They brushed their teeth with 1.5 g test dentifrice (25 s), then swished the slurry ensuring even exposure of specimens (95 s), expectorated, and rinsed (15 mL water, 10 s). After 4 h intraoral remineralization, specimens were removed and acid-challenged in vitro. Surface microhardness (SMH), measured pre-experimental, post-initial acid exposure, post-remineralization, and post-second acid exposure, was used to calculate recovery (SMHR), net acid resistance (NAR), and a new, specifically demineralization-focused calculation, “comparative acid resistance” (CAR). Enamel fluoride uptake (EFU) was also measured. For the F dose-response controls, all measures showed significant relationships with dentifrice F concentration (p < 0.0001). The presence of zinc counteracted the ability of F to promote remineralization in this model. Compared to the 1,426 ppm F control, the zinc formulations gave reduced SMHR, EFU, and NAR (all p < 0.0001); however, they showed evidence of increased CAR (Zn-A: p = 0.0040; Zn-B: p = 0.0846). Products were generally well tolerated. In this study, increasing dentifrice F concentration progressively increased in situ remineralization and demineralization resistance of early caries enamel lesions. Zinc ions reduced remineralization but could increase demineralization resistance.

OBJECTIVES:Data generated from three similar in situ caries crossover studies presented the opportunity to conduct a pooled analysis to investigate how dentifrice formulations with different fluoride salts and combinations at concentrations of 1400-1450 ppm F, different abrasive systems and in some cases, carbomer (Carb), affect enamel caries lesion remineralization and fluoridation. METHODS:Subjects continuously wore modified partial dentures holding two gauze-covered partially-demineralized human enamel specimens for 14 days and brushed 2×/day with their assigned dentifrice: Study 1: sodium fluoride (NaF)/Carb/silica, NaF/silica, NaF + monofluorophosphate (MFP)/chalk; Study 2: NaF/Carb/silica, NaF + MFP/dical, amine fluoride (AmF)/silica; Study 3: NaF/Carb/silica, NaF + stannous fluoride (SnF2)/silica/hexametaphosphate (HMP). All studies included Placebo (0 ppm F) and/or dose-response controls (675 ppm F as NaF [675F-NaF]) ±Carb. Specimens were evaluated for percentage surface microhardness recovery (SMHR) and enamel fluoride uptake (EFU). RESULTS:All 1400-1450 ppm F dentifrices except NaF + SnF2/silica/HMP provided significantly greater lesion remineralization than Placebo (p < 0.0001): differences in SMHR ranged from 17.46% (NaF + MFP/dical) to 26.66% (AmF/silica). For EFU (back-transformed log EFU), all 1400-1450 ppm F dentifrices gave significant fluoride uptake compared to Placebo (p < 0.0001): increases in EFU ranged from 4.95 μg F/cm2 (NaF + SnF2/silica/HMP) to 16.32 μg F/cm2 (NaF/carb/silica). Dentifrices containing NaF or AmF as sole fluoride source provided the greatest remineralization and fluoridation; Carb addition did not alter fluoride efficacy; some excipients appeared to interfere with the cariostatic action of fluoride. Treatments were generally well-tolerated with ≤4 treatment-related adverse events per study. CONCLUSION:Commercially available fluoride dentifrices varied greatly in their ability to remineralize and fluoridate early caries lesions. CLINICAL SIGNIFICANCE:Fluoride dentifrices are the most impactful anticaries modality worldwide. While clinical caries trials have not consistently shown the superiority of one formulation over another, these findings using a sensitive in situ caries model indicated that dentifrices containing NaF or AmF as the sole fluoride source provided the greatest remineralization and fluoridation benefits.

ObjectivesTo compare and explore the dose-response of phytate-containing 1150 ppm fluoride toothpastes on model caries lesions and to determine the impact of zinc ions.MethodsThis was a single-centre, randomised, blinded (examiner/laboratory analyst), six-treatment, four-period crossover, in situ study in adults with a removable bilateral maxillary partial denture. Study treatments were toothpastes containing: 0.425% phytate/F; 0.85% phytate/F; 0.85% phytate/Zn/F; F-only; Zn/F and a 0% F placebo. Where present, F was 1150 ppm as NaF; Zn was 0.3% as ZnCl2. Human enamel specimens containing early-stage, surface-softened (A-lesions) or more advanced, subsurface (B-lesions) caries lesions were placed into the buccal flanges of participants’ modified partial denture (one of each lesion type per side). A-lesions were removed after 14 days of twice-daily treatment use; B-lesions were removed after a further 14 days. A-lesions were analysed for surface microhardness recovery. Both lesion types were analysed by transverse microradiography and for enamel fluoride uptake, with B-lesions additionally analysed by quantitative light-induced fluorescence. Comparison was carried out using an analysis of covariance model.ResultsStatistically significant differences between 1150 ppm F and the placebo toothpastes (p < 0.05) were shown for all measures, validating the model. No differences between fluoride toothpastes were observed for any measure with little evidence of a dose-response for phytate. Study treatments were generally well-tolerated.ConclusionsResults suggest phytate has little impact on fluoride’s ability to promote early-stage lesion remineralisation or prevent more advanced lesion demineralisation in this in situ caries model. Similarly, results suggest zinc ions do not impair fluoride efficacy.Clinical significanceToothpastes may contain therapeutic or cosmetic agents that could interfere with fluoride’s caries prevention efficacy. The present in situ caries study has demonstrated that phytate, added to provide enhanced extrinsic stain removal/prevention, and zinc, added to inhibit malodour, do not impair fluoride efficacy.

OBJECTIVES:The influence of toothbrushing duration and dentifrice quantity on fluoride efficacy against dental caries is poorly understood. This study investigated effects of these two oral hygiene factors on enamel remineralisation (measured as surface microhardness recovery [SMHR]), enamel fluoride uptake (EFU), and net acid resistance (NAR) post-remineralisation in a randomized clinical study using an in situ caries model. METHODS:Subjects (n=63) wore their partial dentures holding partially demineralised human enamel specimens and brushed twice-daily for two weeks, following each of five regimens: brushing for 120 or 45s with 1.5g of 1150ppm F (as NaF) dentifrice; for 120 or 45s with 0.5g of this dentifrice; and for 120s with 1.5g of 250ppm F (NaF) dentifrice. RESULTS:Comparing brushing for 120s against brushing for 45s, SMHR and EFU increased by 20.0% and 26.9% respectively when 1.5g dentifrice was used; and by 22.8% and 19.9% respectively when 0.5g dentifrice was used. Comparing brushing with 1.5g against brushing with 0.5g dentifrice, SMHR and EFU increased by 35.3% and 51.3% respectively when brushing for 120s, and by 38.4% and 43.0% respectively when brushing for 45s. Increasing brushing duration and dentifrice quantity also increased the NAR value. The effects of these two oral hygiene factors on SMHR, EFU, and NAR were statistically significant (p<0.05 in all cases). CONCLUSION:Brushing duration and dentifrice quantity have the potential to influence the anti-caries effectiveness of fluoride dentifrices. Study NCT01563172 on ClinicalTrials.gov. CLINICAL SIGNIFICANCE:The effect of two key oral hygiene regimen factors - toothbrushing duration and dentifrice quantity - on fluoride's anticaries effectiveness is unclear. This 2-week home-use in situ remineralisation clinical study showed both these factors can influence fluoride bioactivity, and so can potentially affect fluoride's ability to protect against caries.

OBJECTIVES:The study compared the effects on examiner-assessed tooth gloss and smoothness of two experimental toothpastes (1% or 2% alumina abrasive) with a reference, silica-based toothpaste used twice daily for one, four, and eight weeks. The study also monitored the safety of the products.METHODS:This was a randomized, examiner-blind study, stratified by gloss score and age, three-treatment, parallel-group using healthy adult volunteers. Following a two-week washout period where subjects brushed with a conventional silica-abrasive toothpaste, 169 subjects began the trial period after receiving a dental scaling and polishing using the washout toothpaste. Subjects brushed for two minutes, twice daily, with their assigned toothpaste. The experimental toothpastes contained 927 ppm fluoride as NaF with either 1% or 2% alumina as the sole abrasive. The reference toothpaste contained 927 ppm fluoride as NaF in a conventional amorphous silica abrasive base. Enamel polish (i.e., gloss) was assessed visually by comparing the facial surfaces of the maxillary incisors with a set of standards. Tooth smoothness was assessed by lightly dragging a dental explorer over the surface.RESULTS:Subjects using the 2% alumina toothpaste had significantly higher gloss compared to the reference toothpaste at Weeks 1 and 4, but the difference was of borderline significance at Week 8 (one-covariate analysis: p = 0.0529; two-covariate analysis: p = 0.0494). Subjects using the 1% alumina toothpaste had significantly higher gloss improvement scores than the reference toothpaste at Weeks 4 and 8, but not at Week 1. All three treatment groups' gloss scores improved during the study. Regarding tooth smoothness, the effects of the experimental toothpastes followed a broadly similar profile to the effects on tooth gloss. After four weeks' use, both experimental toothpastes were superior to the reference. After eight weeks' use, however, only the 2% alumina toothpaste approached significant superiority versus the reference (p = 0.0639).CONCLUSIONS:The 1% and 2% alumina toothpastes improved tooth gloss compared to a standard silica toothpaste when used twice daily for two minutes over an eight-week study period. Furthermore, there was evidence of a corresponding increase in tooth smoothness.

Objective: The objective was to evaluate the ability of fluoride in a conventional, non-specialised sodium fluoride-silica dentifrice to promote tooth remineralisation and enamel fluoride uptake (EFU), and assess the resistance of the newly formed mineral to attack by dietary acid, across the concentration range used in mass-market dentifrices.Methods: Subjects wore a palatal appliance containing eight polished bovine enamel specimens, each including an early erosive lesion. In a randomised full-crossover sequence, 62 healthy subjects were treated with dentifrices containing four different fluoride concentrations: no fluoride; 250 ppm, 1150 ppm and 1426 ppm fluoride. At each treatment visit, under supervision, subjects brushed with 1.5 g dentifrice and rinsed once while wearing the appliance; the appliance was removed after a 4-h remineralisation period and effects on the enamel specimens determined. The primary efficacy variable was surface microhardness recovery (SMHR); others included EFU, relative erosion resistance (RER) and comparative erosion resistance.Results: Highly significant linear and, with the exception of SMHR, quadratic dose-response relationships were observed between all efficacy variables and fluoride concentration. For SMHR, EFU and RER, values for the different fluoride concentrations were statistically resolved from one another, with the exception of the two highest fluoride concentrations. The degree of remineralisation and the acid resistance of enamel after treatment were closely related to EFU.Conclusion: After a single brushing, conventional non-specialised sodium fluoride-silica dentifrices promoted remineralisation of early enamel lesions, and imparted increased acid-resistance to the enamel surface, in a dose-dependent manner at least up to 1500 ppm fluoride.Clinical significance: Enamel erosive tissue loss is an increasing concern, associated with modern diets. This study demonstrated that sodium fluoride, in a conventional non-specialised dentifrice formulation, can promote repair of the earliest stages of enamel erosion after a single application, in a dose-dependent fashion across the fluoride concentration range used in mass-market dentifrices. (C) 2015 The Authors. Published by Elsevier Ltd.