Overview
Stannous Fluoride, or Tn(II) Fluoride, is a compound commonly used in toothpastes for the prevention of gingivitis, dental infections, cavities, and to relieve dental hypersensitivity. Although similar in function and activity to Sodium Fluoride (NaF), the conventionally added ingredient in toothpastes, stannous fluoride has been shown to be more effective at stopping and reversing dental lesions . It manages and prevents dental caries and gingivitis by promoting enamel mineralization , reducing gingival inflammation and bleeding through its potential broad-spectrum antibiotic effect and modulation of the microbial composition of the dental biofilm . It is an FDA-approved over-the-counter product.
Indication
Indicated for use to relieve dental hypersensitivity, increase enamel production, prevent gingivitis and cavities, and control periodontal infections.
Associated Conditions
- Dental Cavity
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/04/13 | Not Applicable | Completed | Procter and Gamble | ||
2019/10/11 | Phase 3 | Completed | |||
2017/09/28 | Not Applicable | Completed | Procter and Gamble | ||
2017/03/07 | Phase 3 | Completed | |||
2016/07/22 | Not Applicable | Completed | Procter and Gamble | ||
2016/07/14 | Phase 3 | Completed | |||
2016/04/27 | Not Applicable | Completed | |||
2016/04/26 | Not Applicable | Completed | |||
2015/11/24 | Not Applicable | Completed | Procter and Gamble | ||
2015/07/31 | Not Applicable | Completed | Procter and Gamble |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Massco Dental A Division of Dunagin Pharmaceuticals | 63783-009 | ORAL | 0.12 g in 120 g | 2/17/2020 | |
| Massco Dental A Division of Dunagin Pharmaceuticals | 63783-006 | ORAL | 0.12 g in 120 g | 2/17/2020 | |
| Haleon US Holdings LLC | 0135-0598 | DENTAL | 1.10 mg in 1 g | 4/22/2025 | |
| Ross Healthcare Inc. | 62007-307 | TOPICAL, DENTAL | 16.4 mg in 1 mL | 1/30/2023 | |
| Haleon US Holdings LLC | 0135-0627 | DENTAL | 1.10 mg in 1 g | 4/22/2025 | |
| Ross Healthcare Inc. | 62007-301 | topical | 16 1 in 1 mg | 2/2/2015 | |
| Massco Dental A Division of Dunagin Pharmaceuticals | 63783-015 | ORAL | 0.12 g in 120 g | 2/17/2020 | |
| Massco Dental | 63783-211 | ORAL | 0.19 g in 100 g | 12/2/2019 | |
| Massco Dental A Division of Dunagin Pharmaceuticals | 63783-012 | ORAL | 0.12 g in 120 g | 12/17/2023 | |
| Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc. | 68400-202 | DENTAL | 0.34 g in 283.5 g | 1/20/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ORAL-B PRO-HEALTH WHITENING TOOTHPASTE tube | 194640 | Medicine | A | 2/16/2012 | |
| ORAL-B PRO-HEALTH ALL-AROUND PROTECTION - CLEAN MINT TOOTHPASTE | 194642 | Medicine | A | 2/16/2012 | |
| ORAL-B PRO-HEALTH ENAMEL SHIELD TOOTHPASTE tube | 194643 | Medicine | A | 2/16/2012 | |
| DRAXIMAGE MAA kit for the preparation of Technetium Tc 99m Albumin Aggregated Injection | 261212 | Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific | Medicine | A | 10/7/2016 |
| GEL-KAM SENSITIVE stannous fluoride 0.4% w/w gel tube | 75054 | Medicine | A | 7/18/2000 | |
| ORAL-B PRO-HEALTH ALL-AROUND PROTECTION - FRESH MINT TOOTHPASTE tube | 194641 | Medicine | A | 2/16/2012 | |
| MYOVIEW kit for the preparation of technetium [99cm Tc] tetrofosmin injection vial | 60998 | Medicine | A | 8/26/1997 | |
| HEPATOLITE powder for injection | 19146 | Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific | Medicine | A | 9/26/1991 |
| ULTRATAG RBC kit for the preparation of Technetium [99mTc] labelled red blood cells | 47860 | Medicine | A | 2/2/1994 |
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