Drugs / sodium monofluorophosphate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) EXTRA-STRENGTH AIM 1986-08-06 fda.gov

Trials 6 · a red edge is where a trial was stopped

198619871988198919901991199219931994199519961997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 33 trials
Phase 3 NCT06300905 Jun → Jul 2023 mouth disorder Colgate Palmolive Completed No outcome recorded
Phase 3 NCT06300866 Aug 2020 → Mar 2021 gingivitis Colgate Palmolive Completed No outcome recorded
Phase 3 NCT02829879 Dec 2015 → Sep 2016 dentin sensitivity University of Chile Unknown No outcome recorded
Phase not applicable3 trials
NCT05916508 Oct → Nov 2020 gingivitis Procter and Gamble Completed No outcome recorded
NCT07317128 Jan → Jun 2013 dentin sensitivity HALEON Completed No outcome recorded
NCT01494649 Sep 2011 dentin sensitivity, hypersensitivity reaction disease GlaxoSmithKline Completed No outcome recorded
Also used as a comparator or background therapy in 35 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT06962956 Comparator Apr → Oct 2025 overdue gingivitis Procter and Gamble Active not recruiting No outcome recorded
Phase 24 trials
Phase 2 NCT06892834 Comparator Mar → Jun 2025 gingivitis Procter and Gamble Completed No outcome recorded
Phase 2 NCT02918617 Comparator May 2015 → Sep 2016 dentin sensitivity The University of Texas Health Science Center at San Antonio Completed No outcome recorded
Phase 2 NCT01831817 Comparator Jan → May 2013 dentin sensitivity GlaxoSmithKline Completed No outcome recorded
Phase 2 NCT01691560 Comparator Aug → Nov 2012 dentin sensitivity GlaxoSmithKline Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT07223060 Comparator May → Oct 2017 dental pulp calcification Colgate Palmolive Completed No outcome recorded
Phase 313 trials
Phase 3 NCT07605338 Comparator May → Nov 2026 expected gingivitis Colgate Palmolive Active not recruiting No outcome recorded
Phase 3 NCT07458464 Comparator May → Jun 2026 overdue gingivitis Colgate Palmolive Not yet recruiting No outcome recorded
Phase 3 NCT07398846 Comparator Jan → Apr 2026 Colgate Palmolive Completed No outcome recorded
Phase 3 NCT06427499 Comparator Apr → Aug 2024 gingivitis Colgate Palmolive Completed No outcome recorded
Phase 3 NCT06353165 Comparator Mar → Apr 2023 Colgate Palmolive Completed No outcome recorded
Phase 46 trials
Phase 4 NCT07614490 Background Apr → Sep 2026 expected gingivitis Colgate Palmolive Recruiting No outcome recorded
Phase 4 NCT07158112 Comparator Aug → Dec 2025 overdue gingivitis Procter and Gamble Active not recruiting No outcome recorded
Phase 4 NCT07029438 Background Jul → Oct 2025 gingivitis Colgate Palmolive Completed No outcome recorded
Phase 4 NCT05731778 Comparator Dec 2018 → Dec 2020 gingivitis Colgate Palmolive Completed No outcome recorded
Phase 4 NCT03936569 Comparator Oct 2018 → Jan 2019 gingivitis Procter and Gamble Completed No outcome recorded
Phase not applicable10 trials
NCT07169188 Comparator Sep → Dec 2025 gingivitis HALEON Completed No outcome recorded
NCT06140758 Comparator Jul → Dec 2023 dental caries Procter and Gamble Completed No outcome recorded
NCT05654662 Comparator Feb → Nov 2023 gingivitis, smooth surface dental caries HALEON Completed No outcome recorded
NCT06659471 Comparator Mar → Jun 2022 gingival disorder Procter and Gamble Completed No outcome recorded
NCT05916521 Comparator Nov 2021 → Feb 2022 gingivitis Procter and Gamble Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 42 sources stand behind the page.

FieldValueCited text
Known as sodium monofluorophosphate “a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium monofluorophosphate (MFP)” NCT02918617
39

“It contains 0.76% w/w Sodium Monofluorophosphate (1000 ppm F) and 0.1% w/w Sodium Fluoride” NCT05654662

“Dentifrice containing 1450 parts per million (ppm) fluoride as sodium monofluorophosphate.” NCT07317128

“Regular fluoride toothpaste containing 0.76% sodium monofluorophosphate.” NCT07169188

Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste” NCT07029438

“Oral rinse containing 1000ppm fluoride as sodium monofluorophosphateNCT02753075

“Marketed sodium monofluorophosphate (0.76 %) toothpaste” NCT03936569

“toothpaste containing 0.76% sodium monofluorophosphateNCT06300866

“toothpaste containing 0.76% sodium monofluorophosphateNCT06300905

“product containing 0.76% sodium monofluorophosphateNCT06353165

“1000ppm fluoride as sodium monofluorophosphateNCT02542943

“0.76% sodium monofluorophosphate toothpaste” NCT01494649

“0.76 % Sodium MonoFluorophosphate (MFP)” NCT05731778

Sodium monofluorophosphate toothpaste” NCT06427499

NCT01592851

NCT07223073

NCT05916521

NCT07614490

NCT07158112

NCT03072719

NCT01827670

NCT06140771

NCT03965039

NCT07398846

NCT02829879

NCT07458464

NCT02832375

NCT01691560

NCT01831817

NCT06140758

NCT07223060

NCT01592864

NCT05916508

NCT06962956

NCT06659471

NCT06892834

NCT00762528

NCT00759031

NCT04123665

NCT02750943

Known as Colgate Great Regular Flavor Toothpaste ClinicalTrials.gov intervention name — accepted as the source's own label NCT07605338
Known as MFP “a standard fluoride dentifrice containing 1,500 ppm fluoride as sodium monofluorophosphate (MFP)” NCT02918617
1

“0.76 % Sodium MonoFluorophosphate (MFP)” NCT05731778

Known as Na MFP “0.76% Sodium Monofluorophosphate (Na MFP) toothpaste” NCT07398846
1

“0.76% Sodium Monofluorophosphate (Na MFP) toothpaste” NCT07458464

Known as SMFP “0.76% sodium monofluorophosphate [SMFP] toothpaste” PMID 39118360 Aug 2024
Known as Sodium monofluorophospate Sodium monofluorophospate dentifrice (1000 ppm F)” NCT01831817
Route Topical “Participants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP)” NCT01827670