Streptococcus Mutans Reduction Early Mother-infant Transmission
27 april 2021 bijgewerkt door: Marine Ortiz Magdaleno, Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
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
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.
Studie Overzicht
Toestand
Voltooid
Conditie
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
58
Fase
- Fase 4
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 45 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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.
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Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
Andere namen:
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Experimenteel: 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.
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Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.
Andere namen:
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Geen tussenkomst: 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.
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Geen tussenkomst: 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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Caries prevalence assessment in pregnant womens
Tijdsspanne: Basal measurement, at the beginning of the third trimester of gestation.
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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.
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Basal measurement, at the beginning of the third trimester of gestation.
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Streptococcus mutans levels identified in pregnant womens
Tijdsspanne: Basal measurement, at the beginning of the third trimester of gestation.
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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.
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Basal measurement, at the beginning of the third trimester of gestation.
|
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Streptococcus mutans levels identified in pregnant womens
Tijdsspanne: Three months after the birth of the child.
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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.
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Three months after the birth of the child.
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Streptococcus mutans levels identified in pregnant womens
Tijdsspanne: 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.
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Six months after the birth of the child
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Genotypes of the isolates of S. mutans in pregnant womens.
Tijdsspanne: Three months after the birth of the child.
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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.
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Three months after the birth of the child.
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Streptococcus mutans levels identified in childrens
Tijdsspanne: Three months after the birth of the child.
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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.
|
Three months after the birth of the child.
|
|
Streptococcus mutans levels identified in children
Tijdsspanne: 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.
|
Six months after the birth of the child.
|
|
Genotypes of the isolates of S. mutans in children.
Tijdsspanne: 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.
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Three months after the birth of the child.
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 januari 2015
Primaire voltooiing (Werkelijk)
1 oktober 2017
Studie voltooiing (Werkelijk)
1 december 2017
Studieregistratiedata
Eerst ingediend
14 april 2021
Eerst ingediend dat voldeed aan de QC-criteria
27 april 2021
Eerst geplaatst (Werkelijk)
3 mei 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
3 mei 2021
Laatste update ingediend die voldeed aan QC-criteria
27 april 2021
Laatst geverifieerd
1 april 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Oral health promotion
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Ja
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Ja
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