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

口腔健康不良和口腔疾病在全球造成4500亿英镑的损失，影响超过35亿人。全球近50%的人口患有牙釉质退化引起的疾病，有证据表明，口腔健康状况不佳可能是其他非传染性疾病（如糖尿病、心血管并发症和肺炎）的关键因素[WHO/IBIS\]。目前的替代品，如氟化物清漆和再矿化溶液，只能治疗牙釉质退化的症状，没有解决方案可以用无毒的化合物来再生牙釉质，这些化合物易于使用，产生可比的结构，机械性能，使用患者自己的唾液。Mintech发明了一种正在申请专利的化合物和工艺，用于制造再生牙釉质的牙齿局部清漆。这种保护漆可能能够取代预防性氟化物保护漆，允许治疗目前无法治疗的疾病，从而显著减轻全球口腔健康疾病负担。口腔疾病是世界上第四大最昂贵的疾病[WHO]。该资助提案旨在进行非侵入性体内研究，以评估疗效和效应量，进行初步健康经济学建模，并准备MHRA提交和CE认证。

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.