COES: Curing Order Effects on Sealants

Recruiting now · Phase 1

Conditions studied: Dental Sealant, Sealant Retention

In brief

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.

Key facts

Study ID

NCT06342258

Run by

University of Southern California

People needed

217

Starts

2024-02-23

Expected to finish

2027-06-01

Last updated by the study team

2026-07-02

Who can join

Age: 5 and older, up to 14. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Herman Ostrow School of Dentistry of USC — Los Angeles, California, United States (enrolling)

Full record on ClinicalTrials.gov

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