DESIGN AND DEVELOPMENT OF FLUORO CALCIUM PHOSPHOSILICATE (FCPS) LOADED MUCOADHESIVE ORAL GEL FOR THE MANAGEMENT OF DENTIN HYPERSENSITIVITY

Sujal Anil Jagnade*, Sagar Tambe Eknath, Jayesh Gangadhar Jadhav, Sahil Sonlal Janwale, Pratham Yogesh Bangar, Avishkar Suresh Kad

Dentin hypersensitivity (DH) remains one of the most frequently encountered and clinically challenging conditions in contemporary dental practice, affecting a significant proportion of adults globally. The condition is defined by a sharp, transient pain originating from exposed dentin in response to various external stimuli — thermal, evaporative, tactile, osmotic, and chemical — that cannot be attributed to any other dental pathology. While a number of therapeutic strategies have been employed over the years, achieving both immediate symptom relief and durable, long-term remineralization of exposed dentinal tubules continues to be an unmet clinical need. Fluoro Calcium Phosphosilicate (FCPS), commercially available as BioMin F, is a second-generation fluoride-incorporating bioactive glass that has demonstrated remarkable promise in the management of DH. Unlike its predecessor calcium sodium phosphosilicate (CSPS/NovaMin), FCPS incorporates fluoride directly into the glass matrix, enabling the sustained, pH-responsive release of calcium, phosphate, and fluoride ions over an extended 12-hour period after application. This ionic milieu fosters the in-situ crystallization of acid-resistant fluorapatite within dentinal tubules, offering superior and lasting tubule occlusion compared to conventional desensitizing agents. Despite these promising properties, the predominant delivery vehicle for FCPS remains toothpaste — a formulation that limits contact time with the dentin surface, reduces the depth of tubular penetration, and provides only transient therapeutic benefit. The development of a mucoadhesive oral gel incorporating FCPS represents a paradigm shift in the delivery of this bioactive material. Mucoadhesive gel systems extend residence time at the application site, allow for sustained and controlled ion release directly onto the exposed dentin, improve bioavailability of the active ingredient, and significantly enhance patient convenience. This review critically examines the pathophysiology of dentin hypersensitivity, the compositional and mechanistic attributes of FCPS, the rationale for adopting a mucoadhesive gel delivery platform, the pharmaceutical design and development considerations for FCPS-loaded oral gels, and the existing clinical and in-vitro evidence supporting this novel therapeutic approach. The review also highlights knowledge gaps and outlines directions for future research in this promising field.