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 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT03685058
Eligibility Criteria:
Inclusion Criteria:
The subject's inclusion criteria:
The child has at least two matched bilateral primary molars and/or first permanent molars with proximal carious lesions in the same surfaces in enamel or outer dentin third as by bitewing radiographic examination and are non-cavitated by visual examination.
* Their ages are five to eight years.
* Healthy.
* No known allergies to any of the components of the dental materials used in the study.
* The parents are willing to commit to the follow-up visits.
* Child is generally cooperative for dental treatment.
The tooth's inclusion criteria:
1. Primary molar and/or first permanent molars with a proximal carious lesion in enamel or outer dentin third assessed by bitewing radiographic examination and that is found to be non-cavitated after ICDAS visual examination.
2. Presence of a tooth adjacent to the lesion.
3. Normal tooth structure.
4. Absence of tooth mobility.
5. Tooth does not require restorative treatment.
Exclusion Criteria:
•The subject's exclusion criteria:
* Children with a medical history of a chronic disease.
* Children who have abnormalities that affect tooth structure.
* The need of sedation or general anesthesia for dental treatment.
The tooth exclusion criteria:
* Primary molar and/or first permanent molars with a proximal carious lesion extending beyond the outer dentin third assessed by bitewing radiographic examination.
* Primary molar and/or first permanent molars with a proximal carious lesion that is cavitated assessed by ICDAS visual examination.
* Non-cavitated proximal carious lesion on the mesial of the first primary molars because the contact area with the primary canine is narrow and the possible presence of the primate space.
* Distal surfaces of the first permanent molars because there is no contact with the second permanent molar (does not erupt in this age group).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
8 Years
Study:
NCT03685058
Study Brief:
Protocol Section:
NCT03685058