Stannous fluoride

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
Stannous Fluoride and Gingivitis	2022/04/13	NCT05326373	Not Applicable	Completed	Procter and Gamble
A Phase 3 Clinical Study Investigating the Gingivitis Efficacy of a Test Dentifrice Containing Stannous Fluoride	2019/10/11	NCT04123665	Phase 3	Completed	GlaxoSmithKline
Analysis of Stannous Fluoride in GCF and Subgingival Plaque	2017/09/28	NCT03296657	Not Applicable	Completed	Procter and Gamble
The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity	2017/03/07	NCT03072719	Phase 3	Completed	GlaxoSmithKline
A Study to Evaluate Sampling Methods for Subgingival Plaque	2016/07/22	NCT02841839	Not Applicable	Completed	Procter and Gamble
Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity	2016/07/14	NCT02832375	Phase 3	Completed	GlaxoSmithKline
Impact of Long Term Management of Dentine Hypersensitivity (DH) With a Daily Use Anti-sensitivity Toothpaste on the Quality of Life Related to Oral Health	2016/04/27	NCT02752958	Not Applicable	Completed	GlaxoSmithKline
Potential of Stannous Fluoride Toothpaste to Reduce Gum Disease	2016/04/26	NCT02750943	Not Applicable	Completed	GlaxoSmithKline
Research on Oral Tolerability and Product Application/Response of Two Oxalate Products for Dental Patients With Risk of Dentinal Hypersensitivity	2015/11/24	NCT02613117	Not Applicable	Completed	Procter and Gamble
A Clinical Study to Determine the Safety and Effectiveness of Dentinal Hypersensitivity Treatment With Two Different Toothbrushes	2015/07/31	NCT02513212	Not Applicable	Completed	Procter and Gamble

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
KIDS CHOICE	Massco Dental A Division of Dunagin Pharmaceuticals	63783-009	ORAL	0.12 g in 120 g	2/17/2020
Equate Optimal Care TP Equate Optimal Care TP	Walmart Inc.	79903-280	ORAL	0.16 g in 100 g	8/12/2025
Equate Pro-Advanced TP Equate Pro-Advanced TP	Walmart Inc.	79903-281	ORAL	0.16 g in 100 g	8/12/2025
Gum Detoxify	Meijer, Inc.	79481-0121	ORAL	0.14 g in 100 g	8/12/2025
Rite Aid Sensitivity and Gum	Rite Aid	11822-5060	DENTAL	0.15 g in 100 g	8/12/2025
Sensitivity and Gum	DG Health (Rexall)	55910-569	DENTAL	0.15 g in 100 g	8/12/2025
KIDS CHOICE	Massco Dental A Division of Dunagin Pharmaceuticals	63783-006	ORAL	0.12 g in 120 g	2/17/2020
parodontax	Haleon US Holdings LLC	0135-0598	DENTAL	1.10 mg in 1 g	4/22/2025
PCXX SNF RNS MINT	Ross Healthcare Inc.	62007-307	TOPICAL, DENTAL	16.4 mg in 1 mL	1/30/2023
parodontax Complete Protection	Haleon US Holdings LLC	0135-0627	DENTAL	1.10 mg in 1 g	4/22/2025

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	Procter & Gamble Australia Pty Ltd	Medicine	A	2/16/2012
ORAL-B PRO-HEALTH ALL-AROUND PROTECTION - CLEAN MINT TOOTHPASTE	194642	Procter & Gamble Australia Pty Ltd	Medicine	A	2/16/2012
ORAL-B PRO-HEALTH ENAMEL SHIELD TOOTHPASTE tube	194643	Procter & Gamble Australia Pty Ltd	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	Colgate-Palmolive Pty Ltd	Medicine	A	7/18/2000
ORAL-B PRO-HEALTH ALL-AROUND PROTECTION - FRESH MINT TOOTHPASTE tube	194641	Procter & Gamble Australia Pty Ltd	Medicine	A	2/16/2012
MYOVIEW kit for the preparation of technetium [99cm Tc] tetrofosmin injection vial	60998	GE Healthcare Australia Pty Ltd	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	Landauer Radiopharmaceuticals Pty Ltd	Medicine	A	2/2/1994

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
1.64% STAN. FLUOR. OFFICE RINSE CONCENTRATE	pdt image inc. dba pro-dentec canada	02117401	Liquid - Dental	1.64 %	12/31/1995
PERFECT CHOICE 0.717% ROOT AND DENTIN DESENS	challenge products inc.	02044951	Liquid - Dental	.4 %	8/28/1996
PERFECT CHOICE HOME GEL 0.4% STANNOUS FLUORIDE GEL	biotrol	00831182	Gel - Dental	0.4 %	10/10/1996
PERFECT CHOICE BRAND PERIO RINSE	biotrol	01986465	Liquid - Oral	0.63 %	8/28/1996
PRO-DENTX COMFORT DENTIN DESENSITIZER	pdt image inc. dba pro-dentec canada	02230747	Liquid - Oral , Dental	0.41 %	4/1/1997
PERIOSELECT STANNOUS FLUORIDE GEL 0.4% MINT	sultan healthcare	01964852	Gel - Dental	.4 %	12/31/1992
USANA ANTICAVITY TREATMENT GEL	usana health sciences inc.	02237647	Gel - Oral	0.4 %	7/27/1998
GEL-KAM FLUOROCARE PART B - MINT LIQ	COLGATE ORAL PHARMACEUTICALS INC	02027186	Liquid - Dental , Topical	1.64 %	12/31/1996
FLUORZOIN 0.4% STANNOUS FLUORIDE GEL	abj custom packaging	02137216	Gel - Topical , Dental	0.4 %	12/31/1995
ORAL B CAVITY PREVENTION FORMULA 0.4%	oral-b laboratories, a div. of procter & gamble inc	02096803	Toothpaste - Dental , Topical	.4 %	12/31/1994

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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