Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04213573
Status:
SUSPENDED
Last Update Posted:
2020-03-26
First Post:
2019-12-18
Brief Title:
Efficacy of Silver Diamine Fluoride and Its Parental Perception
Sponsor:
University of Baghdad
Organization:
University of Baghdad
Study Overview
Official Title:
Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate
Status:
SUSPENDED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
because of corona virus epidemic
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols namely 38 silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate CPP-ACP in arresting dental caries in children
Detailed Description:
The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride SDF in arresting dentin caries lesions when compared to MI Varnish a 5 sodium fluoride varnish which also contains RECALDENT CPP-ACP Casein Phosphopeptide-Amorphous Calcium Phosphate For this healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups Group 1 SDF and Group 2 MI Varnish Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents
Parents guardians of each child will be fully informed regarding the study design objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent The International Caries Detection and Assessment System ICDAS II will be used to determine caries diagnosis and activityvisual and tactile examination will be done with a WHO probe to assess the primary outcome the secondary outcome will be conducted by a questionnaire given to the parents
Parents guardians of each child will be fully informed regarding the study design objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent The International Caries Detection and Assessment System ICDAS II will be used to determine caries diagnosis and activityvisual and tactile examination will be done with a WHO probe to assess the primary outcome the secondary outcome will be conducted by a questionnaire given to the parents
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