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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT04701294
Eligibility Criteria:
Inclusion Criteria:
* Children whose parents accepted their participation in the study and who signed the Informed Consent (Annex 1)
* Children enrolled in the school of the district of Pichanaki, province of Chanchamayo and department of JunÃn
* Children between 6 and 8 years, with permanent upper and / or lower molars with the following characteristics:
Deep cavities and cavities free of cavities, rated 0 and 1 according to ICDAS II Non-cavitated caries in enamel C1 according to ICDAS II Green and Vermillion Simplified Oral Hygiene Index (OHS) of 1 Have a pair of non-cavitated caries-free counterparts.
-Collaborative and receptive children.
Exclusion Criteria:
* Children with the presence of a deep dental caries lesion, with pulp exposure, history of pain and presence of fistula or abscess adjacent to decayed tooth.
* Medically compromised children
* Children with developmental enamel defects.
* Children with a known allergy to any of the resins used
* Children with previously placed sealants or restorations
* Children with bruxism or malocclusion
* Children residing outside the city.
* Children with poor hygiene
Criteria for withdrawal of research subjects
* When they did not attend the evaluations
* If the participant has partial retention and total loss of the sealant, he will be withdrawn from the study after placing a new sealant.
* If a patient moves to another region, it will be grounds for withdrawal from the study.
* If the patient wishes to leave the study, they are considered outside the study
Criteria for termination or interruption of the clinical trial.
* When the 12-month follow-up of all the recruited patients, excluding the withdrawn ones, is completed, the study will be terminated.
* Work is interrupted
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
6 Years
Maximum Age:
8 Years
Study:
NCT04701294
Study Brief:
Protocol Section:
NCT04701294