COES: Curing Order Effects on Sealants
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5-14
SponsorUniversity of Southern California
About this trial
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
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Ultradent Ultra Seal XT Plus
Treatment groups
217 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov