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 @ 11:55 AM
Ignite Modification Date:
2025-12-24 @ 11:55 AM
NCT ID:
NCT01641861
Eligibility Criteria:
Inclusion Criteria:
* Patient inclusion criteria:
* Child is between 7-8 years of ages (at date of enrollment) with at least one active caries lesion in second primary molar tooth with distinct dentine involvement requiring restoration
* Child is in good general health and has no existing health condition that may interfere with treatment such as asthma, tuberculosis, rheumatic fever/ congenital heart diseases, jaundice, juvenile diabetes, haemophilia, thalassemia, leukemia, anemia , HIV , allergy to any drug, and epilepsy.
* Tooth inclusion criteria:
* Second primary molar tooth with one active caries lesion with distinct dentine involvement requiring restoration using the World Health Organization Criteria.
* Tooth with isolated occlusal caries and caries extended on further than two-third of the dentine layer, which can be restoration as a Class I restoration.
* Carious cavity must be large enough so that the hand instruments can be operated.
* Tooth is vital without pathological process assessed clinically and radiographically.
Exclusion Criteria:
* Patient exclusion criteria:
* Child whose parent does not give informed consent.
* Child who are unwilling to undergo the dental treatment.
* Child who has a known allergy to the ingredients contained in dental anesthesia, Papacarie® or glass-ionomer filling material.
* Tooth exclusion criteria:
* Having extensive dental caries which may require pulp treatment.
* Tooth with a pathological process of the dental tissue other than caries that could affect the treatment, such as tooth development disorders or adjacent soft tissue lesion.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
7 Years
Maximum Age:
8 Years
Study:
NCT01641861
Study Brief:
Protocol Section:
NCT01641861