Ignite Creation Date:
2024-05-06 @ 4:04 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04868513
Status:
COMPLETED
Last Update Posted:
2021-05-03
First Post:
2021-04-14
Brief Title:
Streptococcus Mutans Reduction Early Mother-infant Transmission
Sponsor:
Biochemical and Microbiology Laboratory Faculty of Dentistry Autonomous University of San Luis Pot
Organization:
Biochemical and Microbiology Laboratory Faculty of Dentistry Autonomous University of San Luis Pot
Study Overview
Official Title:
Enhancing Effect of the Application of 1 Chlorhexidine Varnish With Silane Fluoride and Oral Health Promotion on the Streptococcus Mutans Counts Reduction in Pregnant Women and on Early Mother-infant Transmission
Status:
COMPLETED
Status Verified Date:
2021-04
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:
Evidence exists on the vertical transmission of Streptococcus mutans from the mother to her children This transmission can be prevented by maintaining maternal oral health during pregnancy
Detailed Description:
The aim of this study was to evaluate the enhancing effect of 1 chlorhexidine varnish together with silane fluoride re-mineralizing varnish and oral health promotion strategy on the reduction of S mutans counts in saliva of pregnant women and the early mother-infant transmission until the first six months of age of the newborn Methods An open random clinical trial of parallel groups was performed 56 pregnant women free of caries were studied prospectively and longitudinally since the third trimester of gestation until 6 months after giving birth the newborns were also assessed until reaching 6 months of age Two groups were formed assigning 28 women to each intervention group G-I received 01 silane fluoride applied as varnish in each visit G-II womens teeth were coated with 01 silane fluoride and 1 chlorhexidine For the primary culture CRT Bacteria system Ivoclar-Vivadent was used for the growth and identification of cariogenic Streptococci Identification of S mutans was performed through PCR The DNA of the isolates identified molecularly as S mutans was used for a second PCR reaction using the arbitrary primer OPA-O2 to determine the homology among the samples of isolated bacteria from the mother-child pair
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