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:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT07270458
Eligibility Criteria:
Inclusion Criteria:
* Children:
1. children aged 4-7 years
2. in good general health, and medically free according to parent history.
3. Cooperative patients
4. Children whom their parents will comply with follow-ups.
5. Children whom their parents who accept to sign informed consent
Tooth:
1. Broad cavitated occlusal lesion with dentinal involvement
2. (Black's Class I cavity) and occlusal access.
3. Radiograph showing dentinal caries up to two-thirds of the dentinal thickness.
4. The consistency of carious lesions ranges from soft to medium hard.
5. Color of carious lesion ranges from light yellow to brown
Exclusion Criteria:
* Children:
1. Medically or developmentally compromising conditions
2. Children who will be unable to attend follow-up visits.
3. Children whom their parents refuse to give written formed consent.
Teeth:
1. Cases requiring restorative treatment that is not of the Class I variety.
2. Extensively damaged teeth.
3. Radiograph showing dentinal caries of more than two thirds of the dentinal thickness.
4. Caries involving pulp or extending below the gingiva.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
7 Years
Study:
NCT07270458
Study Brief:
Protocol Section:
NCT07270458