sodium monofluorophosphate
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 3 | NCT07223073 Comparator | Dec 2017 → Jan 2018 | mouth disorder | Colgate Palmolive | Completed | No outcome recorded |
| Phase 3 | NCT02832375 Comparator | Mar → May 2016 | dentin sensitivity | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT04123665 Comparator | May → Dec 2013 | gingivitis | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01827670 Comparator | Feb → May 2013 | dentin sensitivity | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01592851 Comparator | Apr → May 2012 | dentin sensitivity | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT03072719 Comparator | Mar → Jun 2012 | dentin sensitivity | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01592864 Comparator | Mar → May 2012 | dentin sensitivity | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT00759031 Comparator | Feb → Mar 2008 | — | 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 4 | NCT00762528 Comparator | Feb 2009 → Feb 2010 | gingivitis | Colgate Palmolive | 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 |
| — | NCT06140771 Comparator | Oct 2021 → Feb 2022 | gingivitis | Procter and Gamble | Completed | No outcome recorded |
| — | NCT03965039 Comparator | Jul → Oct 2019 | dentin sensitivity | Procter and Gamble | Completed | No outcome recorded |
| — | NCT02750943 Comparator | Nov 2015 → Mar 2016 | gingivitis | GlaxoSmithKline | Completed | No outcome recorded |
| — | NCT02753075 Background | Sep → Dec 2015 | dentin sensitivity | GlaxoSmithKline | Completed | No outcome recorded |
| — | NCT02542943 Background | Sep → Dec 2015 | dentin sensitivity | GlaxoSmithKline | 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.
| Field | Value | Cited 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 monofluorophosphate” NCT02753075 ↗ “Marketed sodium monofluorophosphate (0.76 %) toothpaste” NCT03936569 ↗ “toothpaste containing 0.76% sodium monofluorophosphate” NCT06300866 ↗ “toothpaste containing 0.76% sodium monofluorophosphate” NCT06300905 ↗ “product containing 0.76% sodium monofluorophosphate” NCT06353165 ↗ “1000ppm fluoride as sodium monofluorophosphate” NCT02542943 ↗ “0.76% sodium monofluorophosphate toothpaste” NCT01494649 ↗ “0.76 % Sodium MonoFluorophosphate (MFP)” NCT05731778 ↗ “Sodium monofluorophosphate toothpaste” NCT06427499 ↗ |
| 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 ↗ |