Project SMILER: A clinical study over the efficacy of the the world's first topical varnish for Stronger MIcro-Layer Enamel Regeneration

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Poor oral health and oral diseases cost £450 billion globally and affect over 3.5 billion people. Nearly 50% of the global population suffers from conditions arising from enamel degradation and evidence suggests that poor oral health may be a key contributor to other non-communicable diseases such as diabetes, cardiovascular complications and pneumonia\[WHO/IBIS\].Current alternatives such as fluoride varnishes and remineralisation solutions only treat the symptoms of receding enamel, and no solution exists that can re-grow enamel with non-toxic compounds that are easy to use, produce comparable structures, mechanical properties, using the patients' own saliva.Mintech has invented a patent-pending compound and process to create a topical varnish for teeth which re-grows enamel. This varnish may be able to replace preventative fluoride varnish, allow treatment of conditions that are currently not possible to treat and thus significantly ease oral health disease burden globally. Oral disease is the 4th most expensive illness in the world\[WHO\].This grant-proposal aims to conduct a non-invasive in-vivo study in order to evaluate efficacy and effect sizes, perform initial health economic modelling and prepare MHRA submission and CE marking.