Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions (NCT07730359) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
United Kingdom20 participantsStarted 2026-07-06
Plain-language summary
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 take the place of fluoride treatments and make a big difference in preventing tooth problems around the world. The purpose of this research study is to demonstrate the efficacy of the Epinamel device in the treatment of dental white-spot lesions.
If you meet all the screening criteria you will be entered into the study and shall have the device applied after the removal of dental braces. Each trial participant will have the treatment product applied to a tooth on one side of the mouth, and a comparative 'control' product named Curodont Repair (vVardis Professional, Switzerland will be applied on the opposite side of the mouth.
Who can participate
Age range
12 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* • 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 ≥20 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:
* • 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, syste…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry.