Streptococcus Mutans Reduction Early Mother-infant Transmission

Sponsor
Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot (Other)
Overall Status
Completed
CT.gov ID
NCT04868513
Collaborator
(none)
58
4
35

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Pregnant women to whom applied silane fluoride
  • Drug: Pregnant women to whom applied silane fluoride + 1% chlorhexidine
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Random clinical trial of parallel groupsRandom clinical trial of parallel groups
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.
Primary Purpose:
Prevention
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
Actual Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Oct 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pregnant women to whom applied silane fluoride

We 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.

Drug: Pregnant women to whom applied silane fluoride
Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
Other Names:
  • Fluor Protector, Ivoclar Vivadent AG™
  • Experimental: Pregnant women to whom applied silane fluoride + 1% chlorhexidine

    We 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.

    Drug: Pregnant women to whom applied silane fluoride + 1% chlorhexidine
    Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.
    Other Names:
  • Fluor Protector, Ivoclar Vivadent AG™ + 1% chlorhexidine
  • No Intervention: Children of the pregnant women to whom it was applied silane fluoride

    The children not given any intervention, they were only subjected to a microbiological and clinical examination.

    No Intervention: Children of the pregnant women to whom it was applied silane fluoride + 1% chlorhexidine

    The children not given any intervention, they were only subjected to a microbiological and clinical examination.

    Outcome Measures

    Primary Outcome Measures

    1. Caries prevalence assessment in pregnant womens [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 [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 [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 [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. [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 [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 [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. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marine Ortiz Magdaleno, Research professor, Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
    ClinicalTrials.gov Identifier:
    NCT04868513
    Other Study ID Numbers:
    • Oral health promotion
    First Posted:
    May 3, 2021
    Last Update Posted:
    May 3, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Marine Ortiz Magdaleno, Research professor, Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 3, 2021