Epinamel Gel for Rebuilding White Spot Lesions Around Braces
Official title: A Pilot Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
Run by Mintech Bio Ltd · NCT07730359 · Data updated 2026-11-12
A gel called Epinamel is being tested to see if it can help white spot lesions around braces regain enamel strength and appearance in teens and adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 12 Years to 60 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Mintech Bio Ltd Industry-sponsored |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | July 6, 2026 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2027 |
| Registry record updated | September 4, 2026 |
| Trial ID | NCT07730359 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 12–60 who recently had braces removed and have at least one active white spot lesion near a bracket site, with good oral hygiene and no conditions affecting saliva.
✕Probably not a fit
Patients without active white spot lesions or with medical factors affecting saliva or enamel remineralization may not benefit from the treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study tests whether Epinamel gel can support remineralization of non-cavitated white spot lesions in patients with braces. Participants receive the gel as a varnish treatment and are monitored for enamel improvement and safety. The trial is conducted with patients aged 12–60 who have recently had braces removed and display active white spot lesions near bracket sites. Outcomes focus on remineralization and durability of the regenerated enamel, alongside any adverse effects. The study is sponsored by Mintech Bio Ltd with collaboration from Guy’s and St Thomas’ NHS Foundation Trust and King’s College London.
Why it matters
Potential benefit: If successful, participants may experience stronger, more natural-looking enamel around treated areas and a reduction in white spot progression.
How similar studies have gone: Prior remineralization approaches exist, but this represents a novel application of Epinamel for enamel regeneration around orthodontic sites.
Who can join: the full rules
Show full inclusion / exclusion criteria
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, systemic, or medical complications * Participants with cavitated lesions
Where it's running
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Guys and St Thomas NHS Foundation Trust Faculty of Dentistry, Oral & Craniofacial Sciences, Kings College London
London, United Kingdom Recruiting
Study contacts
- Study coordinator: Christina Clinical Consultant
- Email: christina@cslifesciences.com
- Phone: +44 7541619940
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Biomin fluoride varnish vs. Duraphat, with or without diode laser, for white spot lesions in primary teeth
This trial tests whether Biomin fluoride varnish, alone or with diode laser, can better remineralize white spot lesions in young children than standard Duraphat varnish.
-
How braces affect the mouth microbiome and saliva proteins in teens
This study follows teens starting orthodontic treatment to see how their mouth bacteria and saliva proteins change over time.
-
Remineralizing White Spot Lesions with P11-4: A three-arm trial
This trial tests whether applying the self-assembling peptide P11-4, alone or with fluoride varnish, can remineralize white spot lesions on permanent teeth in teens.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.