None listed
Conditions
Brief summary
This is a prospective trial designed to evaluate the diagnostic performance of the BlueCheck caries detection system in a cohort of adolescent and adult participants pursuing orthodontic treatment with fixed appliances. The study will recruit participants with at least one active carious lesion, identified by visual inspection. After recruitment, participants will undergo caries diagnosis using both visual inspection and BlueCheck detection (primary objective). Each inspection will be performed by separate assessors. Standardized photographs for orthodontic diagnostic purposes (intraoral frontal and buccal views) will document the dentition before and after BlueCheck detection, and again after BlueCheck removal. Photographic records will subsequently be scored by blinded investigators. Data will be recorded as binary (yes/no) for visual inspection of: 1. initial caries, 2. activity status, and 3. BlueCheck detection. All investigators will have training on caries inspection/assessment evaluations. Lay description: This study will show if caries can be detected by BlueCheck. If so, BlueCheck may be a valuable tool allowing correction of early tooth decay using remineralisation products and obviate the need for more invasive procedures.
Interventions
After the subject's teeth are cleaned as part of routine procedure, a blue dye (BlueCheck) will be painted on the subject's teeth with a dental brush by a oral health professional (1-2 minutes). The subject will then rinse with water (<1 minute), and any residual colour on specific teeth will be noted in data records (2-3 minutes). The blue colour will then be washed off completely with tooth paste (<1 minute). In summary, BlueCheck may be on the teeth up to five minutes.
A second professiona
After the subject's teeth are cleaned as part of routine procedure, a blue dye (BlueCheck) will be painted on the subject's teeth with a dental brush by a oral health professional (1-2 minutes). The subject will then rinse with water (<1 minute), and any residual colour on specific teeth will be noted in data records (2-3 minutes). The blue colour will then be washed off completely with tooth paste (<1 minute). In summary, BlueCheck may be on the teeth up to five minutes. A second professional will observe the subject's teeth using standard tactile / visual methods, inspecting for white spot lesions (3-5 minutes) of which there may be more than one. These areas will be recorded on a separate chart (1-2 minutes). This procedure will be undertaken once. This procedure will be delivered in the clinic. All subjects will undergo the same procedure.
Sponsors
Incisive Technologies Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed