Drugs / sodium fluoride
last change 10 days ago re-read 9 days ago

sodium fluoride

Developed for
dental caries · dentin sensitivity · gingivitis · smooth surface dental caries · tooth erosion, non-bacterial · dentin caries · enamel caries · leukoplakia
+9 more · malposition of teeth with or without hypodontia/oligodontia · periodontitis · pit and fissure surface dental caries · tooth disorder · tooth resorption · gingival disorder · hypersensitivity reaction disease · mouth disorder · periodontal disorder
Investigated by
GlaxoSmithKline · Cairo University · Colgate Palmolive · HALEON · Church & Dwight Company, Inc. · Federal University of Pará
+51 more · Procter and Gamble · University of Campinas, Brazil · University of Michigan · University of Peradeniya · 3M ESPE · Advantage Dental Services, LLC · Advantage Silver Dental Arrest, LLC · Al-Azhar University · Alexandria University · Beaty Dent · Bezmialem Vakif University · Canadian Institutes of Health Research (CIHR) · Conselho Nacional de Desenvolvimento Científico e Tecnológico · Domenick Zero · Dow University of Health Sciences · FENO.Co · Federal University of Santa Maria · Franciscan University Center · Frank Lippert · Hangzhou Occupational Disease Prevention Hospital · Hue University of Medicine and Pharmacy · Indiana University · Indira Gandhi Institute of Dental Science · King Khalid University · MTI University · McCoy Samples Mattingly Dental Clinic · Medical University of Sofia · Nisreen Ibrahim khan · October 6 University · Queensland University of Technology · Riyadh Elm University · SDI Limited · Science,Technology & Innovation Funding Authority, Egypt · Sun Yat-sen University · The Borrow Foundation · The Hospital for Sick Children · The University of Hong Kong · Tripler Army Medical Center · Universidade Estadual de Maringá · Universiti Sains Malaysia · Universiti Teknologi Mara · University of California, San Francisco · University of Guarulhos · University of Jazan · University of Karachi · University of Malaya · University of Pernambuco · University of Science and Technology of Fujairah · University of Toronto · University of Washington · Zhejiang University

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) COLGATE TOTAL — 1997-07-11 fda.gov ↗

Trials 69 · started per year

today
US approved 1997
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19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT06708481 Aug 2024 → Feb 2025 overdue — October 6 University Recruiting No outcome recorded
Phase 0 NCT04620252 Feb 2021 → Mar 2022 dental caries University of Michigan Completed No outcome recorded
Phase 0 NCT02486458 Apr → Dec 2015 dental caries University of Campinas, Brazil Completed No outcome recorded
Phase 17 trials
Phase 1 NCT06316323 Feb → Sep 2023 dental caries Universiti Teknologi Mara Completed No outcome recorded
Phase 1 NCT04239872 Mar 2020 → Apr 2021 — University of Michigan Completed Mixed
Phase 1 NCT03285360 Oct 2017 → Dec 2018 dentin sensitivity Cairo University Completed No outcome recorded
Phase 1 NCT03434782 Apr → Nov 2017 dentin sensitivity Federal University of Pará Completed No outcome recorded
Phase 1 NCT03044171 Aug 2016 → Jan 2017 dentin sensitivity Federal University of Pará Completed No outcome recorded
Phase 1 NCT02645617 Mar → Sep 2016 dental caries Advantage Dental Services, LLC Completed No outcome recorded
Phase 1 NCT01589458 Aug 2011 → Feb 2012 dental caries University of Campinas, Brazil Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT02877888 Aug 2016 → Oct 2018 dental caries University of Peradeniya Completed No outcome recorded
Phase 29 trials · 4 met primary
Phase 2 NCT07371117 Nov 2025 → Feb 2026 dental caries University of Jazan Completed No outcome recorded
Phase 2 NCT06932926 Sep 2025 → Mar 2026 overdue — Cairo University Not yet recruiting No outcome recorded
Phase 2 NCT06892834 Mar → Jun 2025 gingivitis Procter and Gamble Completed No outcome recorded
Phase 2 NCT06174012 Dec 2023 → Nov 2024 overdue — Sun Yat-sen University Not yet recruiting No outcome recorded
Phase 2 NCT03238352 Aug → Oct 2017 dentin sensitivity GlaxoSmithKline Completed Met primary
Phase 2 NCT04183231 Nov 2016 → Feb 2017 dental caries Advantage Silver Dental Arrest, LLC Completed No outcome recorded
Phase 2 NCT02207400 Aug 2014 → Feb 2015 — GlaxoSmithKline Completed Met primary
Phase 2 NCT02207907 Aug 2014 → Feb 2015 — GlaxoSmithKline Completed Met primary
Phase 2 NCT01128972 Aug → Oct 2009 tooth disorder GlaxoSmithKline Completed Met primary
Phase 2/31 trial
Phase 2/3 NCT02128633 Nov 2009 → Jun 2013 dentin sensitivity Federal University of Santa Maria Completed No outcome recorded
Phase 316 trials · 7 met primary · 4 missed
Phase 3 NCT07398846 Jan → Apr 2026 — Colgate Palmolive Completed No outcome recorded
Phase 3 NCT06048627 Mar → Oct 2024 gingivitis Colgate Palmolive Completed No outcome recorded
Phase 3 NCT06010732 Oct 2023 → Feb 2024 dental caries Indiana University Completed Missed primary
Phase 3 NCT05761041 Mar 2022 → Mar 2023 dental caries Alexandria University Completed Missed primary
Phase 3 NCT03383783 Dec 2017 → May 2018 dental caries Domenick Zero Completed No outcome recorded
Phase 3 NCT03296072 Nov 2017 → Jan 2018 tooth erosion, non-bacterial GlaxoSmithKline Completed Met primary
Phase 3 NCT02019160 Sep 2014 → Jun 2018 dental caries The University of Hong Kong Completed Met primary
Phase 3 NCT02341352 Apr 2013 → Apr 2015 dental caries Zhejiang University Unknown No outcome recorded
Phase 3 NCT01641237 Mar → May 2012 tooth erosion, non-bacterial GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT01607411 Feb → May 2012 dental caries GlaxoSmithKline Completed Met primary
Phase 411 trials · 2 met primary · 1 missed
Phase 4 NCT07829328 Sep 2026 → Feb 2027 expected smooth surface dental caries Tripler Army Medical Center Enrolling by invitation No outcome recorded
Phase 4 NCT07807397 Sep 2026 → Sep 2027 expected dental caries, gingivitis Colgate Palmolive Not yet recruiting No outcome recorded
Phase 4 NCT06172764 Dec 2023 → Oct 2025 overdue enamel caries Dow University of Health Sciences Recruiting No outcome recorded
Phase 4 NCT06051981 Oct 2023 → Feb 2024 — Riyadh Elm University Unknown No outcome recorded
Phase 4 NCT05772039 Jan 2022 → Jul 2023 dentin caries Universiti Sains Malaysia Unknown No outcome recorded
Phase 4 NCT04887389 Aug 2021 → Sep 2022 dental caries Nisreen Ibrahim khan Completed No outcome recorded
Phase 4 NCT04050722 Oct → Nov 2019 gingivitis GlaxoSmithKline Completed Met primary
Phase 4 NCT02424097 May 2013 → Oct 2016 smooth surface dental caries University of California, San Francisco Completed No outcome recorded
Phase 4 NCT01128946 Nov 2009 → Mar 2010 dental caries GlaxoSmithKline Completed No outcome recorded
Phase 4 NCT01563172 Jan → Jun 2009 dental caries GlaxoSmithKline Completed Met primary
Phase not applicable21 trials · 5 met primary · 1 missed
— NCT07352956 Jan → Apr 2026 dentin sensitivity HALEON Completed No outcome recorded
— NCT07141576 Sep 2025 → Jul 2026 overdue dentin sensitivity Cairo University Not yet recruiting No outcome recorded
— NCT06896565 Jun → Aug 2025 overdue — Cairo University Not yet recruiting No outcome recorded
— NCT06949072 Apr → Sep 2025 dental caries HALEON Completed No outcome recorded
— NCT06829277 Nov 2024 → Jan 2025 dentin sensitivity MTI University Completed No outcome recorded
— NCT07419737 Oct → Dec 2024 smooth surface dental caries Church & Dwight Company, Inc. Completed No outcome recorded
— NCT07425509 Sep → Nov 2024 — Church & Dwight Company, Inc. Completed No outcome recorded
— NCT07229105 Aug 2024 → Mar 2025 dental caries, leukoplakia, tooth resorption Bezmialem Vakif University Completed No outcome recorded
— NCT05969756 Jul 2023 → Oct 2024 pit and fissure surface dental caries Hue University of Medicine and Pharmacy Completed No outcome recorded
— NCT05654662 Feb → Nov 2023 gingivitis, smooth surface dental caries HALEON Completed Met primary
Comparator or background therapy64 trials
Phase 0 NCT06566833 Comparator Aug 2023 → Oct 2024 — Alexandria University Completed No outcome recorded
Phase 0 NCT03089567 Comparator Sep 2017 → Jan 2018 dental caries Yale University Withdrawn No outcome recorded Stop: Enrollment
Phase 1 NCT07027566 Comparator Jul 2025 → May 2026 overdue dentin sensitivity Federal University of Pará Not yet recruiting No outcome recorded
Phase 1 NCT06358066 Comparator Jun → Nov 2024 — Tanta University Unknown No outcome recorded
Phase 1 NCT06182267 Background Nov → Dec 2023 dental caries Colgate Palmolive Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 137 sources stand behind the page.

FieldValueCited text
Known as sodium fluoride “OBJECTIVE: To measure the effectiveness of fluoride varnish (FV) (Duraflor), 5% sodium fluoride, Pharmascience Inc., Montréal, QC, Canada) and caregiver counseling in...” PMID 18422711 ↗ Apr 2008
133

“OBJECTIVES: To compare three children's sodium fluoride toothpastes to placebo with respect to enamel remineralisation potential, enamel fluoride uptake and net acid resistance...” PMID 24283282 ↗ Dec 2013

“The goal of this 36-month double-blind randomized controlled trial is to compare the effects of 5% sodium fluoride varnish (22,600 ppm fluoride) with or without Strontium-doped...” NCT06131957 ↗

“The students meeting the inclusion and exclusion criteria was randomly assigned, using block randomization in blocks of four, using a computer generated set of random numbers,...” NCT02877888 ↗

“In previous studies, povidone iodine (PVP-I), a widely used bactericidal antiseptic, and sodium fluoride (NaF), used to foster remineralization of enamel, were applied...” PMID 30938600 ↗ Apr 2018

“A chewable candy chewed for 30 seconds, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per...” NCT04620252 ↗

“Children in group A received a semiannual application of a 25% silver nitrate (AgNO3) solution followed by a commercially available varnish with 5% sodium fluoride (NaF) on the...” PMID 32866050 ↗ Aug 2020

“The investigation assessed the clinical effect of a mouthrinse containing chlorhexidine (CHX) and sodium fluoride (NaF) during a 4-day period of non-brushing and a 6-week...” NCT02935322 ↗

“FV (Duraflor®- 5% Sodium Fluoride Varnish, Bubble gum flavor, AMD Medicom, Inc. Quebec, Canada) that is the standard of care will be applied with the manufacturer's supplied applicator.” NCT05272254 ↗

“Sodium fluoride, at a concentration of 0.05% (226 parts per million (ppm) of fluoride), will be used to rinse the mouth for 1 minute and expectorated.” NCT04239872 ↗

“Dental brushing with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months.” NCT03191721 ↗

Show 123 more sources

Known as Charm varnish “five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).” NCT06932926 ↗
Known as Charm varnish R “5% sodium fluoride (22.600ppm) Dentkist-korea Charm varnish R” NCT06358066 ↗
Known as Colgate Cavity Protection “Participants will brush their teeth with Colgate Cavity Protection repair and protect (containing sodium fluoride)” NCT04050722 ↗
Known as Duraflor “OBJECTIVE: To measure the effectiveness of fluoride varnish (FV) (Duraflor), 5% sodium fluoride, Pharmascience Inc., Montréal, QC, Canada) and caregiver counseling in...” PMID 18422711 ↗ Apr 2008
1

“FV (Duraflor®- 5% Sodium Fluoride Varnish, Bubble gum flavor, AMD Medicom, Inc. Quebec, Canada) that is the standard of care will be applied with the manufacturer's supplied applicator.” NCT05272254 ↗

Known as Duraphat “5% NaF varnish (Duraphat, Colgate Palmolive, USA)” NCT05084001 ↗
Known as fluoride varnish 22600ppm “intervention: drug :fluoride varnish 22600ppm topical application every 6 months for a total period of 2 years” NCT02877888 ↗
Known as NaF “The aim of this trial is to investigate the effectiveness of semiannual application of 38% SDF and that of 5% sodium fluoride (NaF) varnish when compared with placebo control...” PMID 35604758 ↗ May 2022
19

“In previous studies, povidone iodine (PVP-I), a widely used bactericidal antiseptic, and sodium fluoride (NaF), used to foster remineralization of enamel, were applied...” PMID 30938600 ↗ Apr 2018

“Considering the widespread use of sodium fluoride (NaF) and monofluorophosphate (MFP) based toothpastes, the present study aim to evaluate F availability in saliva after use of...” NCT01589458 ↗

“Children in group A received a semiannual application of a 25% silver nitrate (AgNO3) solution followed by a commercially available varnish with 5% sodium fluoride (NaF) on the...” PMID 32866050 ↗ Aug 2020

“The investigation assessed the clinical effect of a mouthrinse containing chlorhexidine (CHX) and sodium fluoride (NaF) during a 4-day period of non-brushing and a 6-week...” NCT02935322 ↗

“A possible affordable alternative may be Sodium Fluoride (NaF) varnish combined with good oral hygiene promoted by parental Motivational Interviewing (MI).” PMID 37789300 ↗ Oct 2023

“Arrestment proportion of caries for sodium fluoride varnish was found to be 84.4% (NaF) and 85.3% for ( NaF + chlorohexidine mouth wash) .” NCT03554980 ↗

“Crest Cavity Protection Fresh Lime is containing 1150 parts per million (ppm) fluoride as Sodium fluoride (NaF).” NCT05750745 ↗

“Topical application of varnish fluoride (sodium fluoride NaF) effect on exposed dentine as a desensitizing agent” NCT04484844 ↗

“The Fluoride varnish (containing 5% NaF, Duraphat®, Colgate-Palmolive Company, NY, USA)” NCT06131957 ↗

“Sodium Fluoride with Casein Phosphopeptide-Amorphous Calcium Phosphate (NaF + CPP-ACP)” NCT07371117 ↗

Show 9 more sources

Known as sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00) “sodium fluoride (PCCA Sodium Fluoride USP 51927-1038-00)” NCT01665911 ↗
Route Topical “professionally applied topical fluoride (PATF) applications at regular intervals” NCT00435500 ↗