Ignite Creation Date:
2024-05-06 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03625310
Status:
COMPLETED
Last Update Posted:
2018-08-10
First Post:
2018-07-27
Brief Title:
Effectiveness Fluoride Varnishes in Children With Early Childhood Caries
Sponsor:
Merve Erkmen Almaz
Organization:
Kırıkkale University
Study Overview
Official Title:
Effectiveness of Different Fluoride Varnishes on Salivary Bacteria Levels in Children With Early Childhood Caries
Status:
COMPLETED
Status Verified Date:
2018-08
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 study was carried out in 88 children with severe early childhood caries dmfsage 1 who were referred to the investigators clinic Patients who completed dental treatment under general anesthesia in a single session were included to the study
Patients were divided randomly into 4 groups and after dental treatment one of the fluoride varnish listed below was applied to each child The groups were as follows
1 Duraphat varnish containing 5 Sodium Fluoride Colgate n 22
2 Clinpro White Varnish containing 5 of Sodium Fluoride tricalcium phosphate 3M ESPE n 22
3 Embrace Varnish containing 5 Sodium Fluoride with CXP Pulpdent n 22
4 MI Varnish containing 5 Sodium Fluoride casein phosphopeptide amorphous calcium phosphate varnish GC n 22
Saliva Mutans streptococci MS and Lactobacilli LB levels were evaluated by taking saliva samples before general anaesthesia one month after treatment and three months after treatment
Patients were divided randomly into 4 groups and after dental treatment one of the fluoride varnish listed below was applied to each child The groups were as follows
1 Duraphat varnish containing 5 Sodium Fluoride Colgate n 22
2 Clinpro White Varnish containing 5 of Sodium Fluoride tricalcium phosphate 3M ESPE n 22
3 Embrace Varnish containing 5 Sodium Fluoride with CXP Pulpdent n 22
4 MI Varnish containing 5 Sodium Fluoride casein phosphopeptide amorphous calcium phosphate varnish GC n 22
Saliva Mutans streptococci MS and Lactobacilli LB levels were evaluated by taking saliva samples before general anaesthesia one month after treatment and three months after treatment
Detailed Description:
Duraphat Colgate which we used as a positive control group in our study contains only 5 sodium fluoride It has been reported in studies that Duraphat is effective in remineralization
Clinpro White Varnish another topical varnish in this studywas reported to be effective for caries prevention in pre-school children
One of the varnishes we evaluate in the study Embrace Varnish contains 5 sodium fluoride with xylitol-coated calcium and phosphate According to the manufacturer the xylitol coating prevents the calcium and phosphate salts from reacting until they come in contact with saliva Saliva dissolves the xylitol and releases the calcium and phosphate ions which react with the fluoride ions in saliva to form protective fluorapatite on the teeth19 MI Varnish in the fourth group containing 5 sodium fluoride with casein phosphopeptide amorphous calcium phosphate CPP-ACP had a high release of calcium and fluoride ions
Clinpro White Varnish another topical varnish in this studywas reported to be effective for caries prevention in pre-school children
One of the varnishes we evaluate in the study Embrace Varnish contains 5 sodium fluoride with xylitol-coated calcium and phosphate According to the manufacturer the xylitol coating prevents the calcium and phosphate salts from reacting until they come in contact with saliva Saliva dissolves the xylitol and releases the calcium and phosphate ions which react with the fluoride ions in saliva to form protective fluorapatite on the teeth19 MI Varnish in the fourth group containing 5 sodium fluoride with casein phosphopeptide amorphous calcium phosphate CPP-ACP had a high release of calcium and fluoride ions
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