Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066963
Status:
COMPLETED
Last Update Posted:
2022-03-09
First Post:
2003-08-07
Brief Title:
Fluoride Varnish Randomized Clinical Trial
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Comprehensive Oral Health Center for Discovery New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries Prevention and Treatment Outcomes
Status:
COMPLETED
Status Verified Date:
2022-03
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:
None
Brief Summary:
The purpose of this study is to compare the efficacy of fluoride varnish FV applied once or twice a year with counseling to counseling alone in preventing early childhood caries ECC tooth decay in children under the age of five
Detailed Description:
This project was a prospective randomized clinical trial RCT among initially caries-free children from about six months old when primary teeth erupt up to age three at two public health facilities in San Francisco one serving a primarily Latino and one a primarily Asian population The RCT 1 Compared the efficacy of once or twiceyear fluoride varnish FV application and counseling to counseling alone in preventing early childhood caries ECC 2 Assessed pre-intervention salivary markers biologic and chemical behavioral and demographic factors as predictors of ECC 3 Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC and 4 Determined the salivary fluoride release profile following exposure to fluoride varnish
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None