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

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