COES: Curing Order Effects on Sealants
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- University of Southern California
- Study ID
- NCT06342258
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Dental Sealant
- Sealant Retention
Eligibility Criteria
- Sex
- ALL
- Age
- 5 Years - 14 Years
- Healthy Volunteers
- Accepted
Interventions
- 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.
Study Details
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 Dates
- Start date
- Feb 23, 2024
- Status verified
- May 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 217 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: HeadsHeads indicates the RIGHT side of mouth WILL be cured prior to sealant placement. The left side of the mouth will have bond and sealant cured together after.
- Experimental: TailsTails indicates the LEFT side of the mouth WILL be cured prior to sealant placement. The right side of the mouth will not have bond cured prior to sealant placement.
Primary Outcome Measure
Sealant Longevity [ Time Frame: 2 years ]
Central Contacts
- Catherine Pham, DDS2137400412
- Grace Kim, DDS8604055915
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Herman Ostrow School of Dentistry of USC | Los Angeles | California | 90089 |