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 @ 12:42 PM
Ignite Modification Date:
2025-12-24 @ 12:42 PM
NCT ID:
NCT05362461
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients from 5-9 years of age
* Justification for this age range: Patients younger than 5 years may have open contacts between primary molars.
* Patients more than 9 years may have advanced root resorption and primary teeth might be at advanced stages of exfoliation
* Patients with American Society of Anesthesiologists classification (ASA)-I or II category (medically healthy)
* Parent or legal guardian should consent BWX \[per American Academy of Pediatric Dentistry (AAPD) guidelines\] and CariVu ™ (Dexis) imaging to be completed during same visit
* All selected patients should be in primary or mixed dentition stage with well-established contacts between posterior teeth
* Patient with Frankl behavior assessment score of 3 ("positive") or 4 ("definitely-positive")
* Patient and parent speaking English or Spanish as their preferred language Justification for language: Language barriers may pose challenges to behavior management in pediatric dental patient and thereby reducing the acceptability of dental treatment (confounding factor).
Exclusion Criteria:
* Patients with ASA III or IV (medically complex or special health care needs patient)
* Patients with open contacts between teeth or missing teeth
* Patients who do not need conventional bitewing radiographs per AAPD guidelines
* Patient with Frankl behavior assessment score of 1 ("definitely negative") or 2 ("negative")
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
9 Years
Study:
NCT05362461
Study Brief:
Protocol Section:
NCT05362461