EPIFLUR TM SUMMARY
Each Epiflur™ (sodium fluoride) Tablet is sugar free, saccharine free and erythrosine (FD&C Red Dye #3) free. Each Epiflur™ Tablet 1 mg F* (full-strength) contains 1 mg fluoride ion (F*) from 2.2 mg sodium fluoride (NaF). Each Epiflur™ Tablet 0.5 mg (half-strength) contains 0.5 mg F* from 1.1 mg sodium fluoride (NaF). Each Epiflur™ Tablet 0.25 mg (quarter-strength) contains 0.25 mg F* from 0.55 mg sodium fluoride (NaF). Each tablet for oral administration contains sodium fluoride equivalent to fluoride 0.25 mg, 0.5 mg or 1 mg.
Epiflur TM (FLUORIDE ION) is indicated for the following:
For once daily self-applied systemic use as a dental caries preventive in pediatric patients. It has been established that ingestion of fluoridated drinking water (1 ppm F*) during the period of tooth development results in a significant decrease in the incidence of dental caries.1 Epiflur ™ (sodium fluoride) Tablets were developed to provide systemic fluoride for use as a supplement in pediatric patients from 6 months to age 3 years and older living in areas where the drinking water fluoride content does not exceed 0.6 ppm F*.
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NEWS HIGHLIGHTS
Published Studies Related to Epiflur TM (Fluoride ION)
Assessment of the effects of a stannous fluoride dentifrice on gingivitis in a
two-month positive-controlled clinical study. [2012]
gingivitis... CONCLUSION: An advanced stannous fluoride test dentifrice provided superior
Two-week extrinsic stain removal efficacy of a sodium fluoride dentifrice with
high cleaning silica: results from two randomized, controlled clinical trials. [2012]
PURPOSE: To evaluate a stannous-containing sodium fluoride dentifrice with high
cleaning silica and polychelation technology (test dentifrice) compared to a
currently marketed whitening dentifrice, which carries the ADA Seal of Acceptance
for whitening, for its efficacy in removing existing natural stain over a 2-week
period...
Comparison of the clinical efficacy of a new dentifrice containing 8.0% arginine,
calcium carbonate, and 1000 ppm fluoride to a commercially available sensitive
toothpaste containing 2% potassium ion on dentin hypersensitivity: a randomized
clinical trial. [2012]
period... CONCLUSION: The use ofa new dentifrice containing 8.0% arginine, calcium
Effects of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization and crystallization of enamel subsurface lesions in situ. [2011.11]
OBJECTIVES: Manufacturers are adding fluoride (F) to calcium-containing chewing gums to further promote enamel remineralization. The aim of this study was to assess the effect of a chewing gum containing phosphoryl oligosaccharides of calcium (POs-Ca) and fluoride on remineralization of enamel subsurface lesions, in a double-blind, randomized controlled in situ trial... CONCLUSIONS: Addition of POs-Ca to the chewing gum resulted in significant remineralization of enamel subsurface lesions. Although POs-Ca+F gum was not superior in TMR recovery rate when compared with POs-Ca gum, WAXRD results highlighted the importance of fluoride ion bioavailability in the formation of HAp crystallites in enamel subsurface lesions in situ (NCT01377493). Copyright (c) 2011 Elsevier Ltd. All rights reserved.
The effects of dietary fluoride on growth and bone mineralization in broiler chicks. [2011.09]
Fluoride has been shown to have varying degrees of beneficial effects on bone mineralization and bone strength, despite its toxic effects on growth and leg disorders... It was concluded that even low levels of F, such as those used in the present study, have the potential to increase bone quality.
Clinical Trials Related to Epiflur TM (Fluoride ION)
Glass Ionomer Sealant and Fluoride Varnish Study to Prevent Early Childhood Caries [Recruiting]
Fluorine F 18 Sodium Fluoride Positron Emission Tomography in Evaluating Response to Dasatinib in Patients With Prostate Cancer and Bone Metastases [Recruiting]
This phase II trial is studying how well fluorine F 18 sodium fluoride PET works in
evaluating response to dasatinib in patients with prostate cancer and bone metastases.
Diagnostic procedures, such as fluorine F 18 sodium fluoride positron emission tomography
(PET), may help doctors predict a patient's response to treatment and help plan the best
treatment
Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer [Recruiting]
This clinical trial studies fluorine F-18 sodium fluoride positron emission tomography
(PET)/computed tomography (CT) in diagnosing bone tumors in patients with cancer. Diagnostic
procedures, such as fluorine F-18 sodium fluoride PET/CT, may help find and diagnose bone
cancer
Evaluation of Plaque Fluid Fluoride Retention From Fluoride Toothpastes [Recruiting]
This study is to evaluate the amount of fluoride in plaque fluid after brushing iwth
fluoride dentifrices
Development and Validation of a Multi-Mineral Fluoride Mouthrinse [Not yet recruiting]
The primary goals of this project are to determine the anticaries benefits of a prototype
multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the
remineralization of enamel white-spots (non-cavitated lesions). The selection of patients
with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of
the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel
white-spot lesions.
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