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Bifluorid 12
Bifluorid 12 is a topical fluoride varnish that delivers high-concentration fluoride to tooth surfaces to prevent dental caries and remineralize early enamel lesions.
Bifluorid 12 is a topical fluoride varnish that delivers high-concentration fluoride to tooth surfaces to prevent dental caries and remineralize early enamel lesions. Used for Dental caries prevention in children and adults, Remineralization of early enamel caries lesions, Dentine hypersensitivity management.
At a glance
| Generic name | Bifluorid 12 |
|---|---|
| Sponsor | Dow University of Health Sciences |
| Drug class | Topical fluoride varnish |
| Target | Tooth enamel hydroxyapatite |
| Modality | Small molecule |
| Therapeutic area | Dental/Preventive Medicine |
| Phase | Phase 3 |
Mechanism of action
Bifluorid 12 contains 12% fluoride in a colophony-based varnish formulation that adheres to tooth surfaces, allowing prolonged contact and penetration of fluoride ions into enamel. The fluoride promotes remineralization of demineralized enamel and inhibits bacterial acid production, reducing caries risk. The varnish vehicle extends fluoride retention on teeth compared to rinses or gels.
Approved indications
- Dental caries prevention in children and adults
- Remineralization of early enamel caries lesions
- Dentine hypersensitivity management
Common side effects
- Tooth staining or discoloration
- Mild gingival irritation
- Temporary fluorosis (with excessive use)
Key clinical trials
- Preventing Early Childhood Caries With a Silver Diamine Fluoride Gel (PHASE2)
- Comparative Effectiveness of Remineralization Agents on Attachment-Associated Demineralization in Clear Aligner Patients (NA)
- Evaluation of Biomimetic Mineralization Plus Soft Laser Irradiation in Dentin Hypersensitivity Management (NA)
- Cariostatic and Remineralizing Effects of Three Different Dental Varnishes (PHASE4)
- Arrest of Interproximal Caries Lesion With 38% Silver Diamine Fluoride Solution (PHASE3)
- Remineralization of Dentine Caries Using Two Remineralizing Agents Which Are Nanosilver Fluoride and Casein phosphopeptides_amorphous Calcium Phosphate (NA)
- Silver Diamine Fluoride in Preventing Occlusal Caries in Primary Teeth (PHASE2, PHASE3)
- P11-4 and Nanosilver Fluoride Varnish in Treatment of White Spot Carious Lesions (NA)
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:
- Bifluorid 12 CI brief — competitive landscape report
- Bifluorid 12 updates RSS · CI watch RSS
- Dow University of Health Sciences portfolio CI