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 @ 7:47 PM
Ignite Modification Date:
2025-12-24 @ 7:47 PM
NCT ID:
NCT02918903
Eligibility Criteria:
Inclusion Criteria:
* Primary molar with deep dentin caries involving occlusal \&/or occluso-proximal surfaces.
* Absence of clinical signs and symptoms of irreversible pulpitis such as spontaneous pain. Only presence of pain provoked with stimulation, such as complaints of food impaction when eating is allowed.
* Absence of clinical swelling or pus exudates/fistula of soft or periodontal tissues.
* Absence of abnormal tooth mobility.
* Absence of pain on percussion.
* Restorable tooth.
Radiographic inclusion criteria:
* Extension of dental caries one-third or more of the entire dentin thickness.
* No super- imposition of dental caries on the dental pulp.
* No widened periodontal ligament (PDL) space.
* No radiolucency in the peri-apical or furcation areas.
* No pathologic internal or external root resorption.
* No pulp canal calcification or obliteration.
Exclusion Criteria:
1. Patients experience any signs or symptoms of pulpal or peri-apical pathology.
2. Patients with systemic diseases requiring special dental consideration.
3. Unmotivated, uncooperative patients.
4. Patients unable to attend follow-up visits.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT02918903
Study Brief:
Protocol Section:
NCT02918903