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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT06092151
Eligibility Criteria:
Inclusion Criteria:
* Children aged 2-6 years
* Cavitated dentinal caries in any primary tooth
* No carious involvement of the tooth pulp
* No dental infection secondary to a non-vital tooth
* Parent/carer able to complete consent forms (with the support of an interpreter if necessary)
Exclusion Criteria:
* Allergy to any treatment component
* Caries effecting the pulp
* Infection secondary to a non-vital tooth
* Conditions requiring special considerations for the child's dental management where randomisation would not be appropriate for example a medical history including cardiac defects, oncology, hereditary bleeding, or being immunocompromised.
* Dental anomalies effecting the carious teeth involved: amelogenesis imperfecta, dentinogenesis imperfecta, molar incisor hypomineralisation, abnormal morphology such as double teeth.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
6 Years
Study:
NCT06092151
Study Brief:
Protocol Section:
NCT06092151