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Completed

NCT Number: NCT04868513

Streptococcus Mutans Reduction Early Mother-infant Transmission

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.

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Key information

Conditions

Pregnant Women

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pregnant women to whom applied silane fluoride

Drug

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

Other names: Fluor Protector, Ivoclar Vivadent AG™

Pregnant women to whom applied silane fluoride + 1% chlorhexidine

Drug

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

Other names: Fluor Protector, Ivoclar Vivadent AG™ + 1% chlorhexidine

Primary outcomes

  1. Caries prevalence assessment in pregnant womens

    Time frame: Basal 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.

  2. Streptococcus mutans levels identified in pregnant womens

    Time frame: Basal 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.

  3. Streptococcus mutans levels identified in pregnant womens

    Time frame: Three months after the birth of the child.

    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.

  4. Streptococcus mutans levels identified in pregnant womens

    Time frame: Six 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.

  5. Genotypes of the isolates of S. mutans in pregnant womens.

    Time frame: 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.

  6. Streptococcus mutans levels identified in childrens

    Time frame: Three 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.

  7. Streptococcus mutans levels identified in children

    Time frame: Six 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.

  8. Genotypes of the isolates of S. mutans in children.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 3, 2021
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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