Epiflur TM (Sodium Fluoride) - Summary

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)

Slow-release fluoride devices for the control of dental decay. [2014]
CONCLUSIONS: There is insufficeint evidence to determine the

Fluorides for the prevention of early tooth decay (demineralised white lesions) during fixed brace treatment. [2013]
CONCLUSIONS: This review found some moderate evidence that fluoride

In situ clinical effects of new dentifrices containing 1.5% arginine and fluoride on enamel de- and remineralization and plaque metabolism. [2013]
OBJECTIVE: The primary objective of the three studies reported in this paper was to evaluate the effects of new dentifrices containing 1.5% arginine, an insoluble calcium compound, and fluoride for their ability to promote remineralization of demineralized enamel, and to prevent mineral loss from sound enamel specimens.

A clinical investigation of the efficacy of a dentifrice containing 1.5% arginine and 1450 ppm fluoride, as sodium monofluorophosphate in a calcium base, on primary root caries. [2013]
caries lesions in adults... CONCLUSION: It is concluded that the new toothpaste containing 1.5% arginine and

Two-year caries clinical study of the efficacy of novel dentifrices containing 1.5% arginine, an insoluble calcium compound and 1,450 ppm fluoride. [2013]
A 2-year double-blind randomized three-treatment controlled parallel-group clinical study compared the anti-caries efficacy of two dentifrices containing 1.5% arginine, an insoluble calcium compound (di-calcium phosphate or calcium carbonate) and 1,450 ppm fluoride (F), as sodium monofluorophosphate, to a control dentifrice containing 1,450 ppm F, as sodium fluoride, in a silica base.

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Clinical Trials Related to Epiflur TM (Fluoride ION)

Sodium Fluoride PET/CT for the Evaluation of Skeletal Cancer [Terminated]
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

Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste [Completed]

NUPRO(r) Sensodyne Prophylaxis Paste With NovaMin(r)Sensitivity Relief Study [Completed]
The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.

Whole Body Fluorine F 18 Sodium Fluoride PET/CT Scan and Whole Body MRI in Finding Bone Metastases in Patients With Prostate Cancer [Completed]
This phase 0 trial studies whole body fluorine F 18 sodium fluoride positron emission tomography (PET)/computed tomography (CT) scan and whole body magnetic resonance imaging (MRI) in finding bone metastases in patients with prostate cancer. Diagnostic procedures, such as whole body fluorine F 18 sodium fluoride PET/CT scan and whole body MRI, may help find and diagnose bone metastases.

NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study [Completed]
The study is intended to verify through clinical measurement that the NUPRO Sensodyne Prophylaxis Paste with Novamin provides immediate sensitivity relief as well as extended relief up to 28 days.

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