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 @ 10:51 PM
Ignite Modification Date:
2025-12-24 @ 10:51 PM
NCT ID:
NCT06180369
Eligibility Criteria:
Inclusion Criteria:
* Healthy children aged 8-13 with hypomineralization in their first permanent molars.
* Children without systemic diseases or developmental dental anomalies that could affect hypomineralization.
* Those with at least two molars exhibiting molar-incisor hypomineralization (MIH), specifically scoring 1 and 3 according to the MIH-Tll index.
* Children with a positive or 'definitely positive' cooperation according to the Frankl Behavior Rating Scale (Frankl et al., 1962).
* Absence of spontaneous pain, abscess, mobility, or inter-radicular lesions in the tooth to be treated.
* Patients or their parents consenting to participate in the treatment.
Exclusion Criteria:
* Children with systemic diseases or developmental dental anomalies that could affect hypomineralization.
* To have MIH outside the specified scores.
* Children unable to continue treatment in the chair due to cooperation problems.
* Failure to attend control sessions or a desire not to continue with the study.
* Patients and their parents unwilling to participate in the treatment.
* If the patient cannot attend control sessions or disrupts sessions, they will be withdrawn from the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
13 Years
Study:
NCT06180369
Study Brief:
Protocol Section:
NCT06180369