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

Official title

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

Overview

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.

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.

Primary outcome measures

• Regression or progression of white spot lesions (WSLs), determined by changes in lesion size measured (micrometers) by morphometry. [Time frame: 6 weeks]

Secondary outcome measures (1)

• Laser Fluorescence Readings (DIAGNOdent Pen, KaVo, Biberach, Germany) Objective fluorescence-based assessment of lesion status. [Time frame: 6 weeks]

Eligibility criteria

Inclusion criteria

• • 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;
• Have ≥20 teeth and a BPE score of <3;
• Have completed fixed orthodontic treatment within the past 24-120 hours.
• Are aged 12-60 years
• Are willing and able to attend the on-study visits;
• Are willing and able to understand all study-related procedures;
• Provide written informed consent (by parent/guardian if minor) before participation in the study.
• No systemic diseases or concomitant medication affects salivary flow in order not to negatively affect the remineralising process.

Exclusion criteria

• • 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
• Patients who are participating in another trial
• Patients with tetracycline pigmentation, dental fluorosis, or enamel hypoplasia
• Participants who had evidence of reduced salivary flow, systemic, or medical complications
• Participants with cavitated lesions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United Kingdom · 1 center

• Guys and St Thomas NHS Foundation Trust Faculty of Dentistry, Oral & Craniofacial Sciences — London

Identifiers

NCT: NCT07730359 · CIP01_Rev01 · 10072636

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗