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NCT06342258 · ClinicalTrials.gov registry record · Phase 1
COES: Curing Order Effects on Sealants
A Phase 1 study of Dental Sealant and Sealant Retention, sponsored by University of Southern California.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 217
- Enrollment target
- 1
- Study location
NCT06342258: Recruiting Phase 1 study of Dental Sealant and Sealant Retention, sponsored by University of Southern California.
NCT06342258 is a Phase 1 study of Dental Sealant and Sealant Retention that is actively recruiting participants, run by University of Southern California. The registered enrollment target is 217 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06342258, a Phase 1 study of Dental Sealant and Sealant Retention, is actively recruiting participants, sponsored by University of Southern California.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 217 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Ultradent Ultra Seal XT Plus
Study Locations (1)
California
- Herman Ostrow School of Dentistry of USC - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 217 participants |
| Start Date | 2024-02-23 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What NCT06342258 shows while recruiting
NCT06342258 is an interventional study that assigns participants to a tested intervention. The registered 217 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (262% higher).
The record links to 2 conditions, with Dental Sealant appearing as the primary indexed condition, and to 1 intervention - of which Ultradent Ultra Seal XT Plus is the first listed.
NCT06342258 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT06342258 about?
NCT06342258 is a clinical study titled "COES: Curing Order Effects on Sealants". 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...
What is the current status of trial NCT06342258?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 217 participants. The study started on 2024-02-23. Estimated completion is 2026-06-30.
What conditions does trial NCT06342258 study?
This clinical trial studies the following conditions: Dental Sealant, Sealant Retention.
What interventions are being tested in trial NCT06342258?
The interventions under investigation include: Ultradent Ultra Seal XT Plus (DRUG).
Who is sponsoring clinical trial NCT06342258?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06342258 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06342258's enrollment target sits among peer trials
217 241st of 2000 higher than 1,758 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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