Drugs / sodium fluoride
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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 · HALEON · Colgate Palmolive · Church & Dwight Company, Inc. · Federal University of Pará
+48 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 · 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 · 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 · 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 67 · started per year

today
US approved 1997
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1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
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 No outcome recorded
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
Phase 2 NCT07371117 Nov 2025 → Jan 2026 overdue dental caries University of Jazan Active not recruiting 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 No outcome recorded
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 No outcome recorded
Phase 2 NCT02207907 Aug 2014 → Feb 2015 GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01128972 Aug → Oct 2009 tooth disorder GlaxoSmithKline Completed No outcome recorded
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
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 No outcome recorded
Phase 3 NCT05761041 Mar 2022 → Mar 2023 dental caries Alexandria University Completed No outcome recorded
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 No outcome recorded
Phase 3 NCT02019160 Sep 2014 → Jun 2018 dental caries The University of Hong Kong Completed No outcome recorded
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 No outcome recorded
Phase 49 trials
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 No outcome recorded
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 No outcome recorded
Phase 4 NCT00723515 Feb → Jun 2007 dental caries University of Pernambuco Completed No outcome recorded
Phase not applicable21 trials
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 No outcome recorded
Also used as a comparator or background therapy in 61 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 02 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
Phase 13 trials
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
Phase 211 trials
Phase 2 NCT07455604 Comparator Jan 2026 → Aug 2028 expected dental caries The University of Hong Kong Active not recruiting No outcome recorded
Phase 2 NCT05272254 Background Sep 2022 → May 2027 expected dental caries University of Rochester Recruiting No outcome recorded
Phase 2 NCT04947527 Comparator Jun 2022 → Jun 2024 dental caries Advantage Silver Dental Arrest, LLC Completed No outcome recorded
Phase 2 NCT04750902 Comparator Jan 2021 → Feb 2024 dental caries Colgate Palmolive Completed No outcome recorded
Phase 2 NCT03082196 Comparator Mar 2017 → May 2019 dental caries Advantage Dental Services, LLC Completed No outcome recorded
Phase 2/35 trials
Phase 2/3 NCT04484844 Comparator Oct → Dec 2020 dentin sensitivity Cairo University Unknown No outcome recorded
Phase 2/3 NCT04422860 Comparator Oct 2020 → Sep 2021 dental caries Cairo University Unknown No outcome recorded
Phase 2/3 NCT04485299 Comparator Oct → Dec 2020 dentin sensitivity, hypersensitivity reaction disease Cairo University Unknown No outcome recorded
Phase 2/3 NCT05084001 Comparator Mar 2020 → Jul 2023 pit and fissure surface dental caries The University of Hong Kong Unknown No outcome recorded
Phase 2/3 NCT04804423 Comparator Jan 2020 → Mar 2021 dental caries, dentin sensitivity University Medicine Greifswald Completed No outcome recorded
Phase 311 trials
Phase 3 NCT07398378 Comparator Jun → Jul 2026 overdue mouth disorder Colgate Palmolive Active not recruiting No outcome recorded
Phase 3 NCT07263698 Comparator Dec 2025 → Feb 2026 gingivitis Colgate Palmolive Completed No outcome recorded
Phase 3 NCT07478640 Comparator Apr 2024 → Jun 2025 dentin sensitivity Federal University of Pará Completed No outcome recorded
Phase 3 NCT06180707 Comparator Jan → Mar 2024 dentin sensitivity Federal University of Pará Unknown No outcome recorded
Phase 3 NCT06770114 Comparator Oct 2021 → May 2022 gingivitis Colgate Palmolive Completed No outcome recorded
Phase 47 trials
Phase 4 NCT06608368 Background Oct → Nov 2024 dentin sensitivity HALEON Completed No outcome recorded
Phase 4 NCT03557996 Comparator Dec 2018 → Nov 2019 dental caries Cairo University Unknown No outcome recorded
Phase 4 NCT03554980 Comparator Dec 2018 → Nov 2019 dental caries Cairo University Unknown No outcome recorded
Phase 4 NCT02936830 Comparator Oct 2016 → Mar 2017 dentin sensitivity Riyadh Colleges of Dentistry and Pharmacy Completed No outcome recorded
Phase 4 NCT02319668 Background Feb → Jun 2015 GlaxoSmithKline Completed No outcome recorded
Phase not applicable22 trials
NCT07711132 Comparator Dec 2025 → Dec 2026 expected enamel caries Mansoura University Recruiting No outcome recorded
NCT07273539 Comparator Oct 2025 → Feb 2026 gingivitis HALEON Completed No outcome recorded
NCT07181967 Comparator Sep → Dec 2025 overdue dental caries Assiut University Recruiting No outcome recorded
NCT07056855 Comparator Jul 2025 overdue dentin sensitivity Cairo University Not yet recruiting No outcome recorded
NCT07419763 Comparator Apr → Jun 2025 dental caries Church & Dwight Company, Inc. Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 132 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
128

“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

“Dentifrice containing 5 percent (%) weight by weight (w/w) Potassium nitrate (KNO3) and 1150ppm fluoride as sodium fluoride.” NCT06949072

“Group 3 receiving combination therapy of Diode laser with 5% sodium fluoride varnish to exploit synergistic mechanisms” NCT07141576

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

“Dentifrice containing 5% w/w NovaMin (Calcium Sodium Phosphosilicate) and 1040 ppm fluoride as sodium fluoride.” NCT06608368

“CR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluorideNCT06708481

“Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluorideNCT02399163

“Fluoride Availability in Saliva After Use of Sodium Fluoride or Monofluorophosphate Toothpastes” NCT01589458

“Professional topical 5% sodium fluoride gel application for 5 minutes on the teeth having ICL.” NCT06172764

“It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.” NCT03285360

“The active ingredients are 10% (w/v) Povidone-Iodine and 5% (w/v) Sodium Fluoride CAS.” NCT04947527

“It contains 67% weight/weight (w/w) Sodium Bicarbonate and 0.310% w/w Sodium FluorideNCT05654662

“a 25% silver nitrate (AgNO3) solution followed by a 5% sodium fluoride (NaF) varnish” PMID 30931709 Feb 2019

“five percent sodium fluoride varnish (Charm varnish -Dentkist- Korea).” NCT06932926

“The active ingredients are Povidone Iodine and Sodium Fluoride .” NCT03082196

“The active ingredients are Povidone Iodine and Sodium FluorideNCT02645617

“5% sodium fluoride varnish application every three months” NCT05969756

“negative control dentifrice (containing sodium fluoride)” NCT04050722

“Fluoride toothpaste containing sodium fluoride (NaF)” NCT01128946

Sodium fluoride dentifrice (0.243% sodium fluoride).” NCT07419763

“application of 5.0% sodium fluoride varnish to teeth” NCT00497029

“DentKist Charm Varnish 5% Sodium Fluoride Varnish” NCT06896565

“DentKist Charm Varnish 5% Sodium Fluoride Varnish” NCT07056855

“Toothpaste containing 0.243% w/w sodium fluoride.” NCT06660069

“toothpaste containing 0.24% sodium fluorideNCT06182267

“1450 ppm F as sodium fluoride (NaF)” NCT00752089

Sodium fluoride mouthwash 250 ppm” NCT06048627

“0.243% sodium fluoride toothpaste” NCT02574221

“0.243% sodium fluoride toothpaste” NCT02543060

“0 .044 % sodium fluorideNCT06770114

Sodium fluoride 50mg/ml” NCT02341352

Sodium Fluoride varnish” NCT04422860

“0.243% Sodium FluorideNCT03546491

sodium fluorideNCT02019160

sodium fluorideNCT00758394

sodium fluorideNCT07398378

sodium fluorideNCT00759187

NCT02319668

NCT01009554

NCT07478640

NCT07371117

NCT05772039

NCT01345292

NCT02128633

NCT05064137

NCT02598778

NCT02936830

NCT00708305

NCT01005966

NCT05588518

NCT03296072

NCT01657903

NCT06013735

NCT03571815

NCT03554980

NCT04788550

NCT06566833

NCT07640399

NCT03434782

NCT04887389

NCT01128972

NCT02207400

NCT07211061

NCT07352956

NCT03360266

NCT06749977

NCT02207907

NCT02195583

NCT04485299

NCT07273539

NCT04484844

NCT03089567

NCT06829277

NCT02221349

NCT07425509

NCT06837779

NCT03557996

NCT07455604

NCT03625310

NCT05084001

NCT07711132

NCT07398846

NCT02424097

NCT06174012

NCT04124887

NCT06892834

NCT06358066

NCT07229105

NCT06143670

NCT07153328

NCT03238352

NCT00708123

NCT05761041

NCT01665911

NCT01691560

NCT07419737

NCT07263698

NCT01549587

NCT02486458

NCT01831817

NCT04750902

NCT06180707

NCT06316323

NCT06182267

NCT04249336

NCT00723515

NCT01641237

NCT05560945

NCT03044171

NCT00612469

NCT07027566

NCT06051981

NCT07181967

NCT03323372

NCT02829879

NCT06010732

NCT04804423

NCT02226562

NCT01563172

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 RNCT06358066
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
18

“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

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

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

“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

“a 25% silver nitrate (AgNO3) solution followed by a 5% sodium fluoride (NaF) varnish” PMID 30931709 Feb 2019

“Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF)” NCT03238352

“Topical application of varnish fluoride (sodium fluoride NaF)” NCT04485299

“Sodium Fluoride (NaF)” NCT00708305

“5% NaF varnish” NCT04422860

NCT01128946

NCT03383783

NCT00752089

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