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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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.

Eligibility

Primary outcome measure(s)

• Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry. — 6 weeks
  Classified as the proportion of lesions that: Regress (decrease in size by \>20% at 6 weeks with respect to baseline), Progress (increase in size by \>20% at 6 weeks with respect to baseline), or Remain approximately stable in size (decrease or increase in size by ≤20% at 6 weeks with respect to baseline). Assessment method: Morphometric measurement (micrometers) of standardized, calibrated clinical photographs.

Trial sites (1)