Ignite Creation Date:
2024-05-06 @ 12:50 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03865680
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2019-03-04
Brief Title:
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth
Sponsor:
Nourhan MAly
Organization:
University of Alexandria
Study Overview
Official Title:
Effect of Casein Phosphopeptide Amorphous Calcium Phosphate Fluoride Varnish on Remineralization of White Spot Lesion in Primary Teeth Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2020-04
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:
None
Brief Summary:
The aim of this study is to evaluate the effectiveness of Casein phosphopeptide-amorphous calcium phosphate fluoride varnish CPP-ACP FV in comparison to fluoride varnish FV as a remineralizing agent for white spot lesions in primary teeth WSLs
Detailed Description:
The study is a two parallel arms double blinded randomized controlled clinical trial A total of 180 WSL in primary teeth in chikdren aged 2-5 y and satisfying the inclusion criteria were selected Patients will be randomly allocated into 2 groups allocated to two varnishes study group CPP-ACP FV MI varnish Control group FV Duraphat Both fluoride varnishes applications are applied with identical intensive protocols every 2 weeks for 6 weeks The application of each varnish will be according to manufacturers instructions The operator is not blinded to treatment type Only the participants and statistician are blinded to treatment groups The whole sample N180 will be followed up at 6 weeks and at 18 and 30 weeks for Visio-tactile assessment and DIAGNOdent measurements
Study Oversight
Has Oversight DMC:
None
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?:
None