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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-60
SponsorMintech Bio Ltd

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.

Eligibility criteria

Qualifiers

• 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;

Disqualifiers

• 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

Trial design

Treatments tested in this trial

  • Varnish

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators

Mintech Bio Ltd

Lead sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborator