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Sodium monofluorophosphate/Sodium Fluoride Toothpaste
Sodium monofluorophosphate/Sodium Fluoride Toothpaste is a Topical fluoride agent Small molecule drug developed by GlaxoSmithKline. It is currently in Phase 3 development for Prevention of dental caries (tooth decay), Enamel remineralization.
Fluoride ions strengthen tooth enamel by forming fluorapatite, a more acid-resistant mineral that protects against dental caries.
Fluoride ions strengthen tooth enamel by forming fluorapatite, a more acid-resistant mineral that protects against dental caries. Used for Prevention of dental caries (tooth decay), Enamel remineralization.
At a glance
| Generic name | Sodium monofluorophosphate/Sodium Fluoride Toothpaste |
|---|---|
| Sponsor | GlaxoSmithKline |
| Drug class | Topical fluoride agent |
| Target | Tooth enamel hydroxyapatite |
| Modality | Small molecule |
| Therapeutic area | Dental/Oral Health |
| Phase | Phase 3 |
Mechanism of action
Sodium monofluorophosphate and sodium fluoride both release fluoride ions that are incorporated into the hydroxyapatite crystal structure of tooth enamel, converting it to the more resistant fluorapatite. This process reduces enamel solubility in acidic environments and inhibits bacterial acid production, thereby preventing tooth decay and remineralization of early carious lesions.
Approved indications
- Prevention of dental caries (tooth decay)
- Enamel remineralization
Common side effects
- Dental fluorosis (mild, cosmetic)
- Tooth sensitivity
- Mild gastrointestinal upset if swallowed
Key clinical trials
- The Clinical of Stannous Fluoride Toothpaste and a Newly Designed Toothbrush Compared to Colgate Cavity Protection Toothpaste and a Regular Toothbrush in Reducing Plaque and Gingivitis. (PHASE3)
- A Study to Investigate Stannous Fluoride Containing Toothpaste on Antibacterial Effects in the Different Regions of the Mouth (PHASE3)
- Efficacy of a Stannous Fluoride Toothpaste, Cetylpyridinium Chloride Mouthwash, and Battery Toothbrush Regimen in Reducing Established Dental Plaque and Gingivitis. (PHASE3)
- A Clinical Study Investigating the Efficacy of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health (NA)
- Study to Evaluate the Effectiveness of Test Dentifrice in the Relief of Dentinal Hypersensitivity (NA)
- Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period. (PHASE2, PHASE3)
- A Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste (PHASE3)
- Comparative Efficacy of Floss and Essential Oil/CPC+Zn Mouthwashes in Reducing Dental Plaque and Gingivitis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sodium monofluorophosphate/Sodium Fluoride Toothpaste CI brief — competitive landscape report
- Sodium monofluorophosphate/Sodium Fluoride Toothpaste updates RSS · CI watch RSS
- GlaxoSmithKline portfolio CI
Frequently asked questions about Sodium monofluorophosphate/Sodium Fluoride Toothpaste
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Related
- Drug class: All Topical fluoride agent drugs
- Target: All drugs targeting Tooth enamel hydroxyapatite
- Manufacturer: GlaxoSmithKline — full pipeline
- Therapeutic area: All drugs in Dental/Oral Health
- Indication: Drugs for Prevention of dental caries (tooth decay)
- Indication: Drugs for Enamel remineralization
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