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Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR SODIUM FLUORIDE F 18


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505(b)(2) Clinical Trials for Sodium Fluoride F 18

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03774498 ↗ Effect of Different Over-the-counter Toothpastes on Enamel Remineralization Unknown status Cairo University N/A 2019-01-01 This study will be conducted to compare between recent over-the-counter toothpaste (Novamin & Fluoride) and regular over-the-counter toothpaste (Sodium Fluoride) in remineralization potential, so as to be able to know which of the toothpastes will have a better remineralization potential on demineralized enamel.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Sodium Fluoride F 18

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00005006 ↗ Parathyroid Hormone (PTH) With Alendronate for Osteoporosis Completed National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) Phase 2 1987-09-01 This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00005006 ↗ Parathyroid Hormone (PTH) With Alendronate for Osteoporosis Completed Helen Hayes Hospital Phase 2 1987-09-01 This study investigates the effectiveness of parathyroid hormone (PTH) in combination with alendronate, a standard treatment for osteoporosis that blocks or reduces bone loss. We are using alendronate because it may help protect patients against any possible harmful effects of PTH in cortical bone such as the long bones or hip. We are testing two different treatment schedules of PTH-one in which we give PTH daily and one in which we give PTH for 3 out of every 6 months in a cyclical fashion. The entire study is 21 months long; the active treatment period is 18 months with a 6-month followup period. The main effects we will look for in this study are changes in body chemicals that are signs of bone formation or bone breakdown, and changes in bone density throughout the skeleton. We will randomly assign all study participants, who are women aged 50 and over, to either stay on alendronate alone, receive daily continuous PTH plus alendronate, or receive daily PTH for 3 months out of every 6 for a total of three separate 3-month cycles of PTH plus daily alendronate.
NCT00078026 ↗ An Investigation Into the Short Term Effect of APOMINE in Patients With Osteoporosis or Low Bone Mass Terminated Genzyme, a Sanofi Company Phase 1/Phase 2 2003-08-01 Osteoporosis affects millions of postmenopausal women in the USA. The current approved treatments are all drugs that prevent bone loss and possibly result in small gains in bone mass. Another possible treatment consists of drugs that increase bone formation. There are currently two drugs that stimulate bone formation, sodium fluoride and human parathyroid hormone (hPTH). Neither of these two drugs has been approved by the FDA. APOMINE has shown significant bone formation in animal studies. In this study we plan to test whether APOMINE is able to stimulate new bone formation in women with osteoporosis or low bone mass.
NCT00497029 ↗ Early Childhood Caries Prevention at a Pediatric Clinic Completed University of Maryland Baltimore Dental School N/A 2004-06-01 This purpose of this study was to evaluate effectiveness of a risk-based dental caries prevention program conducted by dental personnel at an urban pediatric primary care clinic serving largely low-income residents of Baltimore, Maryland, and to appraise this program as a model for similar urban pediatric settings.
NCT00497029 ↗ Early Childhood Caries Prevention at a Pediatric Clinic Completed University of Maryland, Baltimore N/A 2004-06-01 This purpose of this study was to evaluate effectiveness of a risk-based dental caries prevention program conducted by dental personnel at an urban pediatric primary care clinic serving largely low-income residents of Baltimore, Maryland, and to appraise this program as a model for similar urban pediatric settings.
NCT00612469 ↗ The Use of Antimicrobial Agents in the Inhibition of Mutans Streptococci in Children With Dental Caries Completed Universidade Federal do Ceara N/A 2005-10-01 The aim of the present study was to compare salivary MS levels in four different groups of children with caries, that have been submitted to intraoral topical treatment with either 1,23% sodium fluoride, 1% chlorhexidine, 3% or 10% vancomycin, during 6 consecutive days. This clinical trial was designed to test two different hypotheses. First, that topical vancomycin would be more effective than chlorhexidine and sodium fluoride in salivary MS reduction. Secondly, a 6-day antimicrobial treatment with either one of these agents would produce a long lasting MS suppression, dispensing repeated antibacterial treatments.
NCT00708097 ↗ In Situ Caries Efficacy of Fluoride Toothpastes Completed GlaxoSmithKline Phase 3 2008-04-01 This study is to evaluate the effect of fluoride dentifrices on enamel with artificial caries lesions in an in situ model
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sodium Fluoride F 18

Condition Name

Condition Name for Sodium Fluoride F 18
Intervention Trials
Dental Caries 12
Dentin Sensitivity 8
Dental Caries in Children 7
Early Childhood Caries 5
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Condition MeSH

Condition MeSH for Sodium Fluoride F 18
Intervention Trials
Dental Caries 22
Prostatic Neoplasms 13
Hypersensitivity 12
Dentin Sensitivity 12
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Clinical Trial Locations for Sodium Fluoride F 18

Trials by Country

Trials by Country for Sodium Fluoride F 18
Location Trials
United States 181
Canada 11
Brazil 10
United Kingdom 6
Egypt 5
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Trials by US State

Trials by US State for Sodium Fluoride F 18
Location Trials
Indiana 17
Maryland 12
New York 9
Texas 7
New Jersey 7
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Clinical Trial Progress for Sodium Fluoride F 18

Clinical Trial Phase

Clinical Trial Phase for Sodium Fluoride F 18
Clinical Trial Phase Trials
Phase 4 19
Phase 3 18
Phase 2/Phase 3 8
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Clinical Trial Status

Clinical Trial Status for Sodium Fluoride F 18
Clinical Trial Phase Trials
Completed 71
Unknown status 9
Recruiting 8
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Clinical Trial Sponsors for Sodium Fluoride F 18

Sponsor Name

Sponsor Name for Sodium Fluoride F 18
Sponsor Trials
GlaxoSmithKline 15
National Cancer Institute (NCI) 13
Cairo University 8
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Sponsor Type

Sponsor Type for Sodium Fluoride F 18
Sponsor Trials
Other 85
Industry 43
NIH 16
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