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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT07212660
Eligibility Criteria:
Inclusion Criteria:
* Consent of a legal representative (usually parents)
* 2 deciduous molars in the need of direct filling therapy class I and/or II in different quadrants (primary or secondary caries, filling loss)
* Classification of caries: caries of all sizes in deciduous molars are included unless they can be treated with fissure sealing (ICDAS 3, 4, 5)
* Sufficient language skills of legal representative and children
* Teeth in the need of indirect pulp capping if necessary (Operator decision)
Exclusion Criteria:
* Cognitive impairment not age-appropriate
* Sensitive tooth (pain at night, irritation-persistent pain, buccal swelling, percussion sensitivity)
* Teeth with severely resorbed roots (anormal tooth mobility)
* Direct pulp capping
* Pulpotomy of an adjacent tooth in the same appointment
* Noncompliant child
* Allergies to material or anaesthetics used in the study
* Sufficient isolation not possible
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
9 Years
Study:
NCT07212660
Study Brief:
Protocol Section:
NCT07212660