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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT02098304
Eligibility Criteria:
Inclusion Criteria:
1. Patient must be 16 to 25 years old
2. Patient must have at least one unrestored molar identified as sound according to the ICDAS coding system
3. Patient must have at least one unrestored erupting (in which case occlusal surface must be such that, apart from minimal presence of an operculum over the distal marginal ridge, it is clear of the gingivae (gum)) or erupted third molar with a caries lesion identified, coded 1, 2 or 3 (according to the ICDAS coding system)
4. Patient must be willing and able to give written informed consent
5. Patient must be willing and able to adhere to study schedule
Exclusion Criteria:
1. Recent tooth bleaching (within previous two weeks of imaging with the Calcivis System)
2. On-going re-mineralisation 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:
16 Years
Maximum Age:
25 Years
Study:
NCT02098304
Study Brief:
Protocol Section:
NCT02098304