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Streptococcus Mutans Reduction Early Mother-infant Transmission

Phase 4
Completed
Conditions
Pregnant Women
Interventions
Drug: Pregnant women to whom applied silane fluoride
Registration Number
NCT04868513
Lead Sponsor
Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
58
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Pregnant women to whom applied silane fluoridePregnant women to whom applied silane fluorideWe applied 0.1% silane fluoride (Fluor Protector, Ivoclar Vivadent AG™) as varnish in all teeth on all faces as a promotion strategy on the reduction of S. mutans.
Pregnant women to whom applied silane fluoride + 1% chlorhexidinePregnant women to whom applied silane fluoride + 1% chlorhexidineWe applied 0.1% silane fluoride (Fluor Protector, Ivoclar Vivadent AG™) and 1% chlorhexidine (Cervitec, Ivoclar Vivadent AG™), both applied as varnish, with a 1 min interval between applications, in all teeth on all faces, using the standardized technique indicated by the manufacturer as a promotion strategy on the reduction of S. mutans.
Primary Outcome Measures
NameTimeMethod
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 womensSix months after the birth of the child

In this measurement was identify 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. Will be 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.

Secondary Outcome Measures
NameTimeMethod
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