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 @ 10:35 PM
Ignite Modification Date:
2025-12-24 @ 10:35 PM
NCT ID:
NCT05443035
Eligibility Criteria:
Inclusion Criteria:
* Healthy children with no adverse systemic conditions;
* At least one permanent first molar with MIH and active caries on the dentin with post-eruptive fracture on a single surface or multiple surfaces with an indication for restorative treatment; direct view and access; no clinical or radiographic signs or symptoms of pulpal involvement;
* Hypomineralized enamel with opacities near the margins of the cavities;
* Occurrence or non-occurrence of dentinal sensitivity.
Exclusion Criteria:
* Clinically: carious lesion only involving the enamel, deficient restorations, small carious lesions in dentin (without access to manual excavator), hidden caries, clinical sign or symptom of pulpal involvement, clinical impossibility of restoration;
* Radiographically: evidence of pulpal involvement;
* Teeth severely affected by MIH without indication for restorative treatment;
* Partially erupted teeth with MIH.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
12 Years
Study:
NCT05443035
Study Brief:
Protocol Section:
NCT05443035