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โ† Trials
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Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions

RecruitingNAAges 12 Years - 60 YearsAllMintech Bio Ltd
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In plain words

What the trial is, and whether it could suit you

Mintech-Bio Ltd is a UK-based start-up company which was created to turn 14 years of research from our co-founder Dr Alvaro Mata at Queen Mary University into a real-world product. Loss of tooth enamel from issues such as decay or erosion is a great cause of dental problems, affecting over half of people around the world. There is also evidence to suggest that having poor oral health may be connected to other health issues such as diabetes, heart problems, and lung infections like pneumonia. While treatments like fluoride varnishes and remineralization solutions can help with the effects of enamel loss, there's currently no easy-to-use option that actually regrows enamel in a way that closely matches the natural look and strength of real enamel. Mintech-Bio has created a special gel that helps rebuild tooth enamel back to its natural strength and structure. This new invention could ta

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ€ข Will have dental braces or brackets removed immediately prior to or up to 48 hours prior to potential study participation * Have at least one active non-cavitated carious lesions around the bracket area with a rough, chalky and matte surface (white spot lesions - WSLs) at each side of the mouth; * Have carious lesion which are fully visible, assessable and accessible; * Are able and willing to observe good oral hygiene throughout the study; * Have โ‰ฅ20 teeth and a BPE score of \<3; * Have completed fixed orthodontic treatment within the past 24-120 hours. * Are aged 12-60 years * Are willing and able to attend the on-study visits; * Are willing and able to understand all study-related procedures; * Provide written informed consent (by parent/guardian if minor) before participation in the study. * No systemic diseases or concomitant medication affects salivary flow in order not to negatively affect the remineralising process. Exclusion Criteria: * โ€ข Patients with known hypersensitivity to glutaraldehyde or any of the product's ingredients. * Patients with severe pulpitis or oral infections * Patients who are still be undergoing treatment using dental braces or brackets at time of study initiation * Patients who are vulnerable * Patients who are participating in another trial * Patients with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia * Participants who had evidence of reduced salivary flow, systemic, or medical complications * Participants with cavitated lesions
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What it tests

  • Varnish
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Where

1 site
Guys and St Thomas NHS Foundation Trust Faculty of Dentistry, Oral & Craniofacial Sciences, Kings College London
London, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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