Ignite Creation Date:
2025-12-24 @ 11:11 PM
Ignite Modification Date:
2025-12-24 @ 11:11 PM
Study NCT ID:
NCT04274569
Status:
UNKNOWN
Last Update Posted:
2020-02-18
First Post:
2019-11-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Three Types of Fluoride Varnish in Preventing Early Childhood Caries
Sponsor:
The University of Hong Kong
Organization:
Study Overview
Official Title:
Are Calcium- and Phosphate-containing Fluoride Varnishes More Effective Than Conventional Fluoride Varnish in Preventing Early Childhood Caries? A Randomized Clinical Trial.
Status:
UNKNOWN
Status Verified Date:
2020-02
Last Known Status:
ENROLLING_BY_INVITATION
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:
This study evaluates and compares the effect of two types of calcium- and phosphate-containing fluoride varnishes to conventional fluoride varnishes in preventing early childhood caries.
Detailed Description:
Fluoride vanish is the most commonly used professionally applied topical agent. Traditional fluoride vanish application has been reported to exhibit significant caries inhibiting effect in both permanent teeth and primary teeth. The greatest advantage of fluoride vanish is its ability to adhere to tooth tissues for a longer period of time that enables improved fluoride uptake. It allows continuous release of fluoride ions into enamel, dentine, plaque, and saliva.The main action of topical fluoride is to retard demineralization and promote remineralization of enamel by the uptake of calcium and phosphates from saliva. The proposed mechanism of action of topical fluoride is the formation of intraoral calcium fluoride reservoirs, which are retained on enamel and slowly released to inhibit mineral loss during demineralization.
However, the formation of the intraoral calcium fluoride reservoirs is limited by the availability of intraoral calcium and fluoride ions. Low concentration of salivary calcium and phosphate ions leads to mineral deposition only at the surface of enamel as a result of low ion concentration gradient. Deposition of minerals at the surface of enamel alone may not improve the structural properties of the deep part of the incipient carious lesions. Hence, many manufacturers have modified fluoride vanish to include calcium and phosphate ions in an attempt to further improve efficacy of fluoride varnishes.
The in vitro remineralizing effects of calcium- and phosphate-containing fluoride vanishes are encouraging and scientifically sound, a longitudinal, high quality clinical study is needed to verify the laboratory findings.
However, the formation of the intraoral calcium fluoride reservoirs is limited by the availability of intraoral calcium and fluoride ions. Low concentration of salivary calcium and phosphate ions leads to mineral deposition only at the surface of enamel as a result of low ion concentration gradient. Deposition of minerals at the surface of enamel alone may not improve the structural properties of the deep part of the incipient carious lesions. Hence, many manufacturers have modified fluoride vanish to include calcium and phosphate ions in an attempt to further improve efficacy of fluoride varnishes.
The in vitro remineralizing effects of calcium- and phosphate-containing fluoride vanishes are encouraging and scientifically sound, a longitudinal, high quality clinical study is needed to verify the laboratory findings.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: