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

NCT07730359 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-07-28

No results posted yet for this study

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.

Conditions

  • White Spot Lesions [Initial Caries] on Smooth Surface of Tooth

Interventions

DEVICE

Varnish

Epinamel is a professional dental product that is indicated for the treatment of white spot lesions. It utilizes a patented technology that promotes enamel repair by entrapping calcium and phosphate from the saliva to grow hydroxyapatite mineral within the white spot lesion and on the tooth surface. Epinamel is a 2-part product. Applying and drying Part A on the surface of the tooth followed by Part B initiates the hardening and setting of the product.

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • Mintech Bio Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07730359 on ClinicalTrials.gov