A randomised oral fluoride retention study comparing intra-oral kinetics of fluoride-containing dentifrices before and after dietary acid exposure.

OBJECTIVE: This exploratory, randomised, single-blind, crossover, study evaluated fluoride and calcium ion concentrations and pH following use of one of two 1450 ppm fluoride (NaF), 5% w/w KNO3 dentifrices: (1) test dentifrice (with cocamidopropyl betaine) with an orange juice (OJ) rinse; (2) test dentifrice with a deionized (DI) water rinse or (3) comparator dentifrice (with sodium lauryl sulphate and tetrasodium pyrophosphate) with an OJ rinse. DESIGN: Eighteen participants used their assigned dentifrice, rinsed with DI water, then expectorate was collected. Sixty min post-brushing, participants rinsed with OJ or DI water then expectorate was collected. Saliva samples were collected pre-brushing and at 1, 5, 10, 15, 30 and 60 min post-brushing and following the 60 min OJ/DI water rinse. The pH of samples was taken. RESULTS: Significant differences (p < 0.05) were found in salivary fluoride ion concentrations between test and comparator dentifrices at 30 and 60 min and following the 60 min OJ rinse, favouring the former. Significant differences were also found between test and comparator dentifrices for salivary calcium ion concentration at 1, 5 and 10 min (p < 0.0001), favouring the former, and between test or comparator + OJ rinse and test + water rinse (p < 0.005), favouring the latter. No pH differences were shown prior to OJ/water rinse. Products were generally well-tolerated. CONCLUSIONS: Results confirmed that acid-labile fluoride is released from the oral cavity following a dietary acid challenge and showed that formulation excipients may impact on retention of such.

A Randomized in situ Clinical Study of Fluoride Dentifrices on Enamel Remineralization and Resistance to Demineralization: Effects of Zinc.

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.

Two Randomized Clinical Studies to Confirm Differential Plaque Removal by Sodium Bicarbonate Dentifrices in a Single Timed Brushing Model.

OBJECTIVES: This study evaluated and compared plaque removal efficacy of commercially available dentifrices containing sodium bicarbonate (NaHCO3) to those without NaHCO3 in a single timed brushing clinical study model. METHODS: Two randomized, examiner-blind, three-period, three-treatment, crossover studies were performed in adults with a mean Turesky modification of the Quigley-Hein Plaque Index (TPI) score of = 2.00. In Study 1, 60 subjects were randomized to commercially available dentifrices containing: (i) 67% NaHCO3 plus 1425 ppm fluoride (F) as sodium fluoride (NaF); (ii) 45% NaHCO3 plus 1425 ppm F as NaF; or (iii) 0% NaHCO3 plus silica and 1450 ppm F as NaF. In Study 2, 55 subjects were randomized to commercially available dentifrices containing: (i) 67% NaHCO3 plus 1425 ppm F as NaF; (ii) 0% NaHCO3 plus silica and 1400 ppm F as amine F/stannous F; or (iii) 0% NaHCO3 plus chlorhexidine/aluminum lactate and silica with 1360 ppm F as aluminum F. In both studies, subjects brushed their teeth for one timed minute under supervised conditions. Plaque was assessed pre- and post-brushing according to a six-site modification of the TPI. Mean TPI score was analyzed using an analysis of covariance model with treatment and study period as fixed effects, subject as a random variable, and pre-brushing score as a covariate. RESULTS: In both studies, mean TPI score decreased in all groups post-brushing compared with pre-brushing. In Study 1, statistically significant improvements in mean TPI score were reported with the 67% and 45% NaHCO3 dentifrices compared with the 0% NaHCO3 dentifrice (p = 0.0003 and p = 0.0005, respectively). In Study 2, improvements in mean TPI score were statistically significantly greater with the 67% NaHCO3 dentifrice compared with both 0% NaHCO3 dentifrices (p < 0.0001 for both comparisons). All dentifrices were generally well tolerated. CONCLUSIONS: A single timed brushing with commercially available dentifrices containing 67% or 45% NaHCO3 exerted a significantly greater effect on plaque removal than commercially available dentifrices without NaHCO3.

Efficacy of daily intranasal fluticasone propionate on ocular symptoms associated with seasonal allergic rhinitis.

BACKGROUND: Allergic rhinitis (AR) is an inflammatory condition of the nasal mucosa characterized by symptoms of nasal discharge, itching, sneezing, and congestion. Ocular symptoms are commonly associated with AR and include itching or burning, tearing or watering, and redness. Intranasal corticosteroids are a mainstay of treatment, and their effect on nasal symptoms is well described. OBJECTIVE: To demonstrate that a 14-day course of 200 µg/d of nasal fluticasone propionate is superior to placebo in relieving ocular symptoms associated with AR. METHODS: This was a randomized, double-blind, parallel group, multicenter study comparing 200 µg/d of fluticasone propionate with placebo in patients with seasonal allergic rhinitis. The primary end point was mean change from baseline in patient-rated reflective total ocular symptom score (rTOSS). Key secondary end points included mean change from baseline in the morning and evening rTOSS, end-of-treatment assessment of response, and effect on activities of daily living. The primary analysis was performed using analysis of covariance with a linear fixed-effects model. RESULTS: Fluticasone was statistically significantly more efficacious in reducing the ocular symptoms of AR than placebo. The least squares mean difference in the change from baseline of rTOSS was -0.36 (P = .002). A statistically significant difference in mean change from baseline was observed in favor of fluticasone for morning and evening rTOSS. Significantly more patients taking fluticasone achieved an overall response compared with placebo. Fluticasone had a significantly greater effect on daily living activities and was well tolerated. CONCLUSION: This study supports the efficacy of fluticasone in treating ocular symptoms associated with AR. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01817790.

A randomised clinical trial to assess control of oral malodour by a novel dentifrice containing 0.1%w/w o-cymen-5-ol, 0.6%w/w zinc chloride.

OBJECTIVES: To assess the ability of a 0.1% w/w o-cymen-5-ol/ 0.6% w/w zinc chloride/ sodium fluoride dentifrice to control oral malodour compared to a sodium fluoride control dentifrice. DESIGN: Following baseline measurement of oral volatile sulfur compounds (VSCs), the subjects brushed twice daily for 1 week with either the test or control dentifrice. The VSC concentration in breath samples was monitored up to 12 hours post-treatment, by gas chromatography (GC). RESULTS: 75 subjects were included in the efficacy analysis. Relative to the sodium fluoride control dentifrice group the o-cymen-5-ol/ zinc chloride/ sodium fluoride dentifrice exhibited statistically significant reductions (P<0.0001) in hydrogen sulfide, methyl mercaptan and total measured VSCs immediately and after 1, 2, 3 and 12 (overnight) hours post-treatment. CONCLUSION: The results of the present clinical study demonstrated that the use of the 0.1% w/w o-cymen-5-ol/ 0.6% w/w zinc chloride/ sodium fluoride dentifrice over a one week period provided a statistically significant benefit in controlling oral malodour for up to 12 hours post-treatment compared to a sodium fluoride control dentifrice.

Evaluation of mouthrinse and dentifrice regimens in an in situ erosion remineralisation model.

OBJECTIVES: To compare the effectiveness of dentifrice/mouthrinse regimens in a clinical in situ erosion remineralisation model. METHODS: Thirty-six subjects completed a randomised single-blind cross-over trial of five treatment regimens. R1: Dentifrice A [1450 ppm fluoride as the sodium salt (NaF), 50000 ppm potassium nitrate (KNO(3))] plus 450 ppm fluoride (NaF) rinse; R2: Dentifrice A plus sterile water rinse; R3: Dentifrice B (fluoride-free Dentifrice A) plus sterile water rinse; R4: Dentifrice B plus 450 ppm fluoride (NaF) rinse; R5: Dentifrice C (1000 ppm fluorine as sodium monofluorophosphate, 450 ppm fluoride as NaF) plus sterile water rinse. Subjects wore a palatal appliance holding eight pre-demineralised enamel blocks. A 60 min interval separated in vivo use of dentifrice and rinse with the appliance retained in situ for 4h. Efficacy endpoints were percentage surface microhardness recovery (%SMHR) following remineralisation, and percentage relative erosion resistance (%RER) of recovered specimens following a subsequent in vitro erosive challenge. Statistical analyses included ANOVA and selected twin-tailed t-tests. RESULTS: Mean %SMHR (±SE) was (a)42.14±1.39, (b)38.02±1.39, (c)30.57±1.39, (b)37.75±1.39 and (c)30.88±1.39 for regimens R1-R5 respectively (different superscripts denote statistically significant differences (p<0.05) between treatment regimens). Mean %RER (±SE) was (a)-2.88±2.16, (b)-14.54±2.16, (c)-40.05±2.16, (a)-3.76±2.16 and (d)-29.48±2.16 for regimens R1-R5 respectively. R1 elicited statistically significantly greater %SMHR versus all comparator regimens (p<0.01), and conferred statistically significantly greater %RER than comparator regimens (p<0.0001) except R4 (p=0.70). CONCLUSIONS: The combination treatment of dentifrice A containing 1450 ppm fluoride with the 450 ppm fluoride mouthrinse elicited significant enhancements in rehardening of incipient enamel erosive lesions, and significantly increased their subsequent resistance to a second erosive challenge.