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Amine Fluoride Toothpaste
Amine fluoride toothpaste delivers fluoride ions to tooth enamel to strengthen it and prevent dental caries through remineralization.
Amine fluoride toothpaste delivers fluoride ions to tooth enamel to strengthen it and prevent dental caries through remineralization. Used for Prevention of dental caries (cavities), Remineralization of early enamel lesions, Fluoride supplementation for caries-prone patients.
At a glance
| Generic name | Amine 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
Amine fluoride is an organic fluoride compound that penetrates tooth enamel more effectively than inorganic fluorides, promoting remineralization of early carious lesions and creating a protective fluoride layer. The amine component enhances substantivity (prolonged retention on tooth surfaces), extending the anti-cariogenic effect beyond the brushing period.
Approved indications
- Prevention of dental caries (cavities)
- Remineralization of early enamel lesions
- Fluoride supplementation for caries-prone patients
Common side effects
- Dental fluorosis (with excessive ingestion)
- Mild gingival irritation
- Unpleasant taste
Key clinical trials
- 6-month Clinical Investigation Assessing the Efficacy of an Antimicrobial Mouthrinse in Reducing Established Plaque and Improving Gum Health (PHASE4)
- Clinical Research Study to Assess the Efficacy of Two Brushing Regimens (PHASE3)
- Early Caries Lesion Management Observational Study
- Comparative Study Between Photodynamic Therapy With Urucum and LED and Probiotics in Halitosis Reduction (PHASE1)
- Evaluation of the Antibacterial Effect of a Toothpaste Containing Zinc Lactate (PHASE3)
- Assessment of the Cytotoxic and Genotoxic Effect of Toothpastes With Different Forms of Fluoride on the Buccal Mucosa (NA)
- Total Salivary Fluoride Concentration of Healthy Adult Subjects Following Toothbrushing With Different Formulations of Fluoridated Toothpastes With and Without Post-brushing Water Rinsing. (NA)
- Effect of Toothpaste on the Reduction of Plaque and Inflammation (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:
- Amine Fluoride Toothpaste CI brief — competitive landscape report
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- GlaxoSmithKline portfolio CI