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 @ 12:05 AM
Ignite Modification Date:
2025-12-25 @ 12:05 AM
NCT ID:
NCT06342258
Eligibility Criteria:
Inclusion Criteria:
* ASA I and ASA II children, aged 5 to 14 years who are patients of CDHC and USC with adequate eruption of permanent first or second molars for placement of sealants
* These teeth will not have previous restorations, interproximal lesions, pathology, or occlusal lesions.
* Behavior of the children should be within a Frankl 3 or 4 category, indicating a "positive" and "Definitely Positive" behavior rating, which would allow for safe and controlled execution of the proposed protocol
* Patient must have contralateral molars in the same arch in which sealants can be placed. For example a child with #30 and #19 present will qualify for the study.
Exclusion Criteria
* Any tooth with previous sealant placement
* Children who are allergic or intolerant to sealant material
* Children who cannot tolerate a dental suction isolation system, such as DryShield isolation
* Children who do not complete a prophy cup polish.
* Children who present with banded or bracketed molars
* Patients or Parents who cannot fully understand an English or Spanish Consent/ Assent form.
Withdrawal Criteria
* Patients can withdraw voluntarily at any time.
* Any tooth which has progression of caries beyond ICCMS Category 3 will be withdrawn from the study. These teeth will be treated with appropriate restorative dental treatment according to the standard of care.
* Any qualifying tooth that subsequently requires a restoration due to trauma will be withdrawn from the study.
* Any patient with an adverse reaction to treatment will be withdrawn. This event will be reported to the IRB.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
14 Years
Study:
NCT06342258
Study Brief:
Protocol Section:
NCT06342258