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 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT04763057
Eligibility Criteria:
Inclusion Criteria:
* • Presence of active carious lesions involving either occlusal or proximal surfaces of primary molars.
* Extension of carious lesion such that complete caries removal would risk pulp exposure.
* History of tolerable dull intermittent pain, mild discomfort associated with eating, negative history of spontaneous extreme pain.
* Radiographically, carious lesion involving more than 2/3rd thickness of dentin approximating the pulp, normal lamina dura, normal periodontal ligament space, more than 2/3rd of root present, no periapical changes, no pathologic external or internal resorption.
Exclusion Criteria:
* • History of spontaneous sharp, penetrating pain, or tenderness on percussion
* Presence of tooth mobility, discoloration, sinus opening, or abscessed tooth.
* Radiographically, presence of interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency, internal or external resorption.
* Pulp exposure during caries removal.
* Parental refusal for participation.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
8 Years
Study:
NCT04763057
Study Brief:
Protocol Section:
NCT04763057