At a glance
ClinicalIndex Comparison Record- ✓Age 6 years or older
- ✓One unrestored, accessible, sound smooth buccal surface on a canine or incisor (ICDAS 0, no visible lesions)
- ✓One unrestored, accessible, erupting or erupted molar or premolar with visible lesion (ICDAS 2 or 3) in a plaque stagnation area
- ✓Willing and able to provide informed consent (patient or parent/guardian)
- ✕Recent tooth bleaching within 2 weeks of imaging
- ✕Ongoing remineralization treatment including high concentration prescription fluoride toothpaste
- ✕Fixed orthodontic appliance in place
- ✕Currently enrolled in or recently participated (within 3 months) in another clinical research study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Clinical Study to Evaluate the Safety and Performance of the Calcivis System for Identifying Active Demineralization on Tooth Surfaces
In Brief
A clinical study evaluating Imaging with the Calcivis System for Dental Caries. Completed, enrolled 110 participants across 4 sites.
Detailed Summary
This is a prospective, multi-centre clinical study to evaluate the safety and performance of the Calcivis Caries Activity Imaging System. Dentists will identify tooth surfaces as either sound (inactive) or unsound (active caries lesion present) according to ICDAS staging (International Caries Detection and Assessment System). Images of the tooth surface will be taken with the Calcivis System immediately before and after application of a disclosing solution containing a bioluminescent protein. Presence or absence of elevated luminescence on the images will indicate activity / inactivity of the presence or absence of active demineralisation on the tooth surfaces. The study will be deemed a success if there is 70% agreement and above between: 1. elevated luminescence and the presence of active caries as determined by the dentists, and 2. absence of luminescence and the determination of a sound tooth surface by the dentists.
Study Details
Timeline
Interventions
Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and a black \& white and luminescent image of each tooth taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)