NCT07730359

Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions

StatusRecruiting

PhaseNot applicable

SponsorMintech Bio Ltd

Primary completionJan 31, 2027 (estimated)

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Record History

All 2 versions: 1 with changes below, 1 re-verified with no change.

Jul 22, 2026 Study First Submitted

Endpoints

Primary

Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry.

Timeframe: 6 weeks

Secondary (1)

Laser Fluorescence Readings (DIAGNOdent Pen, KaVo, Biberach, Germany) Objective fluorescence-based assessment of lesion status.

Arms and interventions

Treatment groupExperimental

Epinamel one side of mouth Curadont opposite side of mouth

Devices: Varnish

Sites

1 site in 1 country

Guys and St Thomas NHS Foundation Trust Faculty of Dentistry, Oral & Craniofacial Sciences, Kings College LondonLondon, United Kingdom

About this trial

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.

Trial details

Enrollment: 20 participants (estimated)
Started: Jul 6, 2026
Study completion: Jan 31, 2027 (estimated)
Eligibility: 12 to 60, all sexes, no healthy volunteers
Design: Interventional, open label, treatment
Oversight: No data monitoring committee
Conditions: White Spot Lesions [Initial Caries] on Smooth Surface of Tooth
Collaborators: Guy's and St Thomas' NHS Foundation Trust
Official title: A Pilot Clinical Investigation of the Performance of Epinamel for Dental White Spot Lesions
First posted: Jul 28, 2026
Registry updated: Sep 4, 2026
Last verified: Jul 2026

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