NCT06342258 COES: Curing Order Effects on Sealants
| NCT ID | NCT06342258 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Southern California |
| Condition | Dental Sealant |
| Study Type | INTERVENTIONAL |
| Enrollment | 217 participants |
| Start Date | 2024-02-23 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 217 participants in total. It began in 2024-02-23 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Background: Sealants are a great tool in the prevention of caries in the pediatric population. It has been shown that up to 71% of occlusal decay is preventable after a single sealant application in a fissure, and thus is the standard of care due to difficulty for pediatric patients in hygiene, diet, and overall home care until manual dexterity increases. Purpose: This prospective randomized case control study aims to look at the longevity of sealants with bonding agent cured prior to sealant placement vs those with uncured bond. The study will be performed by USC graduate pediatric personnel. Methods: A split mouth prospective randomized control study will be performed on pediatric dental patients at Long Beach Memorial's Children's Dental Health Clinic and USC Pediatric Dental Clinic, placing sealants with cured bond on half of a mouth and sealants with uncured bond on the contralateral half. Intraoral photos will be obtained at the initial visit and recalls to evaluate the overall retention/longevity of the sealant placement. The goal of this study is determine which sealant has higher longevity and to provide recommendations for future pediatric dentists regarding sealant procedures.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06342258 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 14 Years, studying Dental Sealant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06342258 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06342258 currently recruiting?
Yes, NCT06342258 is actively recruiting participants. Contact the research team at cathph@ostrow.usc.edu for enrollment information.
Where is the NCT06342258 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT06342258 clinical trial?
NCT06342258 is sponsored by University of Southern California. The trial plans to enroll 217 participants.