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
This trial accepts healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Ultradent Ultra Seal XT Plus
DrugEach child who has erupted, bilateral permanent molars that qualify for the study and agree to participate will have a side (right or left side) of their mouth randomized for bond that will be cured prior to sealant placement. Daily flossing and oral hygiene instructions will be taught to patients of all study groups. Sealant will be placed using a dental suction isolation system, such as DryShield isolation after prophy cup polish with pumice. No enameloplasty will be conducted.
Treatment groups
217 Participants
are divided into 2 treatment groupsGroup A: HeadsExperimental treatment 1 intervention
Group B: TailsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Sealant Longevity
The primary outcome is measuring sealant longevity with intraoral photos and clinical exams. The outcome will be measured as retention (yes/no) and will be evaluated at 4 time points: 6 months, 12 months, 18 months, and 24 months as compared to initial baseline photos taken at treatment day. Patients/parents will be blinded to treatment status. The evaluation of intraoral photos will be performed by blinded practitioners.
Time frame
2 yearsSecondary outcomes
1
Caries
Secondary objectives of this study aim to look at caries incidence of sealed permanent molars, by monitoring recurrent caries under sealant placement.
Time frame
2 years2
Molar hypomineralization
Sealant longevity of pit and fissure sealants of hypomineralized versus non hypomineralized molar, classified using Mathu-Muju Wright Classification, with only mildly hypomineralized molars being utilized for the study.
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov