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

SMILER 项目：世界上第一个局部清漆对于增强微层牙釉质再生功效的临床研究

• 批准号: 10072636
• 金额: $ 56.14万
• 依托单位: MINTECH-BIO LIMITED
• 依托单位国家: 英国
• 项目类别: Collaborative R&D
• 财政年份: 2024
• 资助国家: 英国
• 起止时间: 2024 至 无数据
• 项目状态: 未结题
• 来源: https://gtr.ukri.org/projects?ref=10072636
• 关键词: Project; SMILER; clinical; study; over

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.

不良的口腔健康和口腔疾病在全球造成了 4500 亿英镑的损失，影响了全球近 50% 的人口患有牙釉质退化引起的疾病，有证据表明，不良的口腔健康可能是导致其他非传染性疾病的一个关键因素。例如糖尿病、心血管并发症和肺炎\[WHO/IBIS\]。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缩的症状，并且不存在可以解决这一问题的解决方案。使用患者自己的唾液，使用易于使用的无毒化合物重新生长牙釉质，产生可比的结构和机械性能。Mintech 发明了一种正在申请专利的化合物和工艺，用于制造可重新生长的牙齿的局部清漆这种清漆可以取代预防性氟化物清漆，可以治疗目前无法治疗的疾病，从而显着减轻全球口腔疾病的负担。口腔疾病是世界上第四大昂贵的疾病。世界\[世界卫生组织\]。该拨款提案旨在进行非侵入性体内研究，以评估功效和效应大小、执行初始健康经济模型并准备 MHRA 提交和 CE 标志。