Epinamel: Advanced dental enamel regeneration. V1.
Research type
Research Study
Full title
A pilot clinical investigation of the performance of the Epinamel device for dental white spot lesions
IRAS ID
359707
Contact name
Avijit Banerjee
Contact email
Sponsor organisation
Mintech-Bio Ltd
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
The purpose of this research study is to indicate the efficacy of the Epinamel enamel repair device in the treatment of dental white spot lesions — early signs of dental caries — after removal of dental braces or brackets.
Dental caries is the most prevalent chronic disease globally, affecting 2 billion adults and 514 million children[WHO,2021], including 31% of the UK population[Dentalhealth.org,2024]. It causes enamel degradation, leading to serious complications such as infections and tooth loss.
White spot lesions are chalky marks that appear on the teeth, signalling enamel decay and, if untreated, can develop into cavities. Current treatments, such as fluoride varnishes, may slow down this process, but they do not rebuild lost enamel and can have side effects. At present, there is no treatment that can reverse these early lesions and fully restore the enamel.Mintech-Bio has created a special treatment which helps rebuild tooth enamel to its original strength and structure. Epinamel utilises calcium and phosphate ions from a patient’s saliva to mineralise and strengthen the natural enamel tissue. Epinamel uniquely regenerates enamel structure, surpassing current fluoride-based treatments that only deposit transient minerals, offering a long-lasting, cost-effective solution.
The study will aim to recruit approximately 20 men and women aged 12-60, inclusive, who will have the treatment device applied to one side of their mouth, and a control treatment (Curodont Repair) applied to the other side of their mouth. The study will consist of three study visits - one pre-eligibility visit, one visit at Week 0, and the final visit at Week 6 (with an allowance of +2 weeks). During visits, study assessments such as fluorescence readings, and teeth imaging for patient teeth will take place.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
25/YH/0177
Date of REC Opinion
14 Jan 2026
REC opinion
Further Information Favourable Opinion