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elmex gel
Elmex gel delivers high-concentration fluoride to tooth surfaces to strengthen enamel and prevent dental caries.
Elmex gel delivers high-concentration fluoride to tooth surfaces to strengthen enamel and prevent dental caries. Used for Prevention of dental caries (cavities), Enamel strengthening and remineralization.
At a glance
| Generic name | elmex gel |
|---|---|
| Also known as | fluoride |
| Sponsor | Hadassah Medical Organization |
| Drug class | Topical fluoride agent |
| Target | Tooth enamel (hydroxyapatite) |
| Modality | Small molecule |
| Therapeutic area | Dental/Oral Health |
| Phase | FDA-approved |
Mechanism of action
The gel contains sodium fluoride or amine fluoride that penetrates the enamel structure, promoting remineralization and increasing resistance to acid attack from plaque bacteria. Regular application helps prevent tooth decay by forming a protective fluoride layer on the tooth surface.
Approved indications
- Prevention of dental caries (cavities)
- Enamel strengthening and remineralization
Common side effects
- Dental fluorosis (with excessive ingestion)
- Mild gum irritation
- Unpleasant taste
Key clinical trials
- Efficacy of Different Agents in Treatment of Initial Caries on Smooth Surfaces in Permanent Teeth in Children (PHASE3)
- Dentine Hypersensitivity Treated With Laser and Fluoride. (NA)
- A Prospective, Randomized, Clinical Study on the Effects of CPP-ACP-paste, Fluoride and a Combination on the Evolution of White Spot Lesions in Orthodontic Patients After Debonding. (NA)
- A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2 (NA)
- Remineralisation of White Spot Lesions by Elmex® gelée in Post-orthodontic Patients (PHASE4)
- Elmex Gel Efficacy in Preventing White Spot Lesions (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:
- elmex gel CI brief — competitive landscape report
- elmex gel updates RSS · CI watch RSS
- Hadassah Medical Organization portfolio CI