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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT06826456
Eligibility Criteria:
Inclusion Criteria:
* Participants of age 6-12 years old
* Patients ranking definitely positive or positive on Frankl behavior rating scale
* Having at least two bilateral fully erupted first permanent molars with untreated non-cavitated occlusal surfaces with deep grooves, the included teeth will have International Detection and Assessment System (ICDAS-II)/ severity scores 0, 1 or 2
* Initial DIAGNOdent Score not exceeding value of 25 indicating only enamel involvement
* Patients whom their parents are willing to comply with all study procedures and protocols and will be given an informed consent to participate
Exclusion Criteria:
* Patients with any known medical history of systemic diseases
* Patients having first permanent molar with hypoplastic or hypocalcified enamel
* Patients using medications that may affect the oral flora or salivary flow
* Patients treated with in-office fluoride treatment within the last 3 months prior to being enrolled in the study.
* Patients showing evidence of poor oral hygiene according to Silness and Löe plaque index
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT06826456
Study Brief:
Protocol Section:
NCT06826456