Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342258
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-26
Brief Title:
COES Curing Order Effects on Sealants
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Effects of Cured Bond On Sealant Retention In The Pediatric Population
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COES
Brief 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 Memorials Childrens 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 retentionlongevity 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
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 Memorials Childrens 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 retentionlongevity 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
Detailed Description:
The primary objective of this prospective randomized control trial is to test the longevity of pit and fissure resin sealants placed with cured bonding agent compared to resin sealants placed with uncured bonding agent over a 2 year period Sealants will be evaluated at 6 month recall visits 6 month recall 12 month recall 18 month recall and 24 month recall as determined by comparing time lapse intraoral photos and clinical examinations Secondary objectives of this study aim to look at caries incidence of sealed permanent molars by monitoring recurrent caries under sealant placement Additionaly looking at 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None