Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT02780856
Eligibility Criteria:
Inclusion Criteria:
1. Patient must be 6 years or older
2. Patient must have one unrestored, accessible, free smooth buccal surface on a canine or incisor, away from the gingival surface identified with no visible lesions (coded ICDAS 0) and/or
3. Patient must have one unrestored, accessible, erupting or erupted molar or premolar with a visible lesion identified as (coded ICDAS 2 or 3) in a plaque stagnation area
4. Patient and / or parent or guardian must be willing and able to give written informed consent
5. Patient and / or parent or guardian must be willing and able to adhere to study schedule
Exclusion Criteria:
1. Any patient with recent tooth bleaching (within previous two weeks of imaging with the Calcivis System)
2. Any patient having on-going re-mineralization treatment including, but not limited to high concentration prescription fluoride toothpaste
3. Any patient with a fixed orthodontic appliance
4. Any patient currently taking part in a clinical research study, or has taken part in a clinical research study in the previous three months
5. Pregnant and / or nursing mothers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
100 Years
Study:
NCT02780856
Study Brief:
Protocol Section:
NCT02780856