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Streptococcus Mutans Reduction Early Mother-infant Transmission

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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04868513
Enrollment
58
Registered
2021-05-03
Start date
2015-01-31
Completion date
2017-12-31
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnant Women

Keywords

chlorhexidine varnish, silane fluoride, Streptococcus mutans, vertical transmission

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 0.1% silane fluoride applied as varnish in each visit. G-II women's teeth were coated with 0.1% 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.

Interventions

DRUGPregnant women to whom applied silane fluoride

Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.

DRUGPregnant women to whom applied silane fluoride + 1% chlorhexidine

Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.

Sponsors

Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)

Masking description

Two groups were formed assigning 28 women to each intervention group. G-I received 0.1% silane fluoride applied as varnish in each visit. G-II women's teeth were coated with 0.1% silane fluoride and 1% chlorhexidine. For the primary culture, CRT Bacteria® system (Ivoclar-Vivadent™) was used for the growth and identification of cariogenic Streptococci.

Intervention model description

Random clinical trial of parallel groups

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant women in the third trimester with a normal and healthy pregnancy. * Ages ranged from 18 to 45 years * Free of caries (if caries were present, they were treated before enrolling them in the study).

Exclusion criteria

-Non-pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Caries prevalence assessment in pregnant womensBasal measurement, at the beginning of the third trimester of gestation.For this purpose, the Decayed, Missing, and Filled Teeth Index was used to measure the prevalence of caries. This index is based on in-field clinical examination of individuals by using a probe, mirror and cotton rolls, and simply counts the number of decayed, missing (due to caries only) and restored teeth the number of participants with prevalence of caries will be reported.
Streptococcus mutans levels identified in pregnant womensBasal measurement, at the beginning of the third trimester of gestation.In this measurement was identified the S. mutans counts in the saliva of pregnant women after the applications of 1% chlorhexidine varnish together with the application of silane fluoride re-mineralizing varnish or only with the application of silane fluoride, was reported the distribution of cariogenic Streptococcus levels in mothers.
Genotypes of the isolates of S. mutans in pregnant womens.Three months after the birth of the child.The genotypes describes an organism's complete set of genes, in this study, was determined the homology among the samples of isolated bacteria from the mother-child pair. The molecular PCR test was implemented for the identification. Will be reported the % of S. mutans genotypes isolated from the mothers of both groups to the strains isolated from the newborns.
Streptococcus mutans levels identified in childrensThree months after the birth of the child.In this measurement was identified the S. mutans counts in the saliva of the children. Will be reported the distribution of cariogenic Streptococcus levels in the children.
Streptococcus mutans levels identified in childrenSix months after the birth of the child.In this measurement was identified the S. mutans counts in the saliva of the children. Will be reported the distribution of cariogenic Streptococcus levels in the children.
Genotypes of the isolates of S. mutans in children.Three months after the birth of the child.The genotypes describes an organism's complete set of genes, in this study was determined the homology among the samples of isolated bacteria from the mother-child pair, was reported the % of S. mutans genotypes isolated from the children.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026