Synthetic enamel and uses thereof
Inventors
Fan, Yuwei • MENGARI, Lina Fahad N. • Sun, Zhi
Assignees
Publication Number
US-12350353-B2
Publication Date
2025-07-08
Expiration Date
2043-11-16
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Abstract
The present disclosure relates to compositions and methods for restoring enamel, e.g., on tooth surfaces.
Core Innovation
The invention provides remineralization compositions and methods for restoring enamel, for example on tooth surfaces such as dentin, dentin tubules, root surface, root canal, or cementum. The remineralization composition generally comprises calcium ions, phosphate ions, and fluoride ions, and is doped with strontium ions or stannous ions. The composition has an ionic strength ranging from about 100 mM to about 500 mM and a pH of about 6 to about 8. The doped strontium or stannous ions provide a synergistic remineralization activity.
The problem being addressed is the need for improved remineralization compositions and methods for enamel restoration. Existing treatments, including fluoride therapy, plaque control, biomimetic glass and ceramics, and oligopeptide P11-4, are insufficient for effective enamel restoration. The present disclosure introduces compositions that can grow new enamel under physiological conditions that closely match the natural enamel in mineral density, chemical composition, crystal phases, hierarchical structure, and hardness. This results in a synthetic enamel layer that integrates seamlessly with natural tooth structures and occludes dentin tubules, thereby preventing secondary decay and restoration failure.
Claims Coverage
The patent includes one independent claim with several dependent claims detailing specific features of remineralization compositions and methods.
Remineralization composition with calcium, phosphate, fluoride, and strontium or stannous ions
A composition comprising calcium ions (about 0.1 mM to 500 mM), phosphate ions (about 0.1 mM to 100 mM), fluoride ions (about 0.2 ppm to 300 ppm), with strontium ions (about 0.05 ppm to 300 ppm) or stannous ions (about 0.1 ppm to 50 ppm), having pH no less than 7.1 to about 8, and ionic strength of about 50 mM to 500 mM.
The independent claim centers on a remineralization composition containing calcium, phosphate, fluoride, and doped with strontium or stannous ions at defined concentrations, pH, and ionic strength to enable enamel remineralization.
Stated Advantages
The composition and methods enable synthetic enamel growth that closely mimics natural enamel's mineral density, chemical composition, crystal phases, hierarchical structure, and hardness.
The synthetic enamel integrates fully and seamlessly with existing tooth structures, including enamel and dentin.
Penetration of enamel-like crystals deeper than 50 micrometers inside dentin tubules enhances sealing and bonding to dentin, which prevents secondary decay and failure.
The compositions exhibit synergistic remineralization activity due to doping with strontium or stannous ions.
Documented Applications
Restoration of enamel on tooth surfaces including dentin, dentin tubules, root surface, root canal, or cementum.
Remineralization of damaged dental surfaces such as demineralization, decay, abrasion, superficial to moderate fractures, Non-Cavitated Caries Lesions (NCCL), tooth fracture, and tooth discoloration.
Dentin tubule occlusion or sealing, tooth desensitization, root canal irrigation and sealing, enamel hardening, and fissure filling.
Formulations as oral care compositions including mouthrinses, toothpastes, sprays, foams, chewing gum, lozenges, and delivery devices such as night guards, custom trays, aligners, sticky stripes, or microencapsulates.
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