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 @ 4:11 PM
Ignite Modification Date:
2025-12-24 @ 4:11 PM
NCT ID:
NCT03553966
Eligibility Criteria:
Inclusion Criteria:
* age 3-6 years
* complete set of fully erupted primary molars (teeth 55, 54, 64, 65, 75, 74, 84, 85)
* presence of a caries restoration (filling) on a minimum of 1 primary molar
* minimum of 4 primary molars without a restoration or fissure sealing
Exclusion Criteria:
* untreated caries lesions of ICDAS code 3-6
* known hypersensitivity to one of the ingredients of the toothpastes to be tested
* systemic disorders interfering with salivary function or flow
* regular medication intake interfering with salivary function or flow
* need for antibiotic prophylaxis during dental treatments
* participation in any other clinical study within the past 3 months or ongoing
* lack of intellectual or physical ability to conduct the study properly
* any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
6 Years
Study:
NCT03553966
Study Brief:
Protocol Section:
NCT03553966