BlueCheck: a blue dye for detection of early-stage caries

Not Applicable

• Conditions: Dental caries; Tooth decay; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12621000166875
• Lead Sponsor: Incisive Technologies Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-18
• Study Completion: 2023-12-15
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Healthy participants > 12 years of age undergoing fixed-appliance orthodontic treatment
will be recruited.
• Able to read, understand and sign the Participant Information and Consent Form
• If under 18 years of age, must have a legal guardian sign the Participant Information
and Consent Form

Exclusion Criteria

• Presence of oral ulcerations (chronic or acute)
• Presence of exposed dentine on the reference tooth surfaces
• Presence of carious lesions with cavitation on the reference tooth surfaces
• Presence of developmental defects of enamel on the reference tooth surfaces
• Allergic to meat or any of the components of BlueCheck or a history of alpha-gal
syndrome
• Unable or unwilling to participate in the required study procedures (e.g. due to religious,
moral, or ethical objection over exposure to cow-derived (non-Halal, non-Kosher)
material as is used in the manufacture of BlueCheck)
• Currently receiving intensive remineralisation therapy (e.g. fluoride varnish, tooth
mousse), or have received such therapy within the last 1 month.
• Pregnancy as disclosed by the participant

Study & Design

• Study Type: Interventional
• Study Design: Not specified