Streptococcus Mutans Reduction Early Mother-infant Transmission
27 aprile 2021 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
58
Fase
- Fase 4
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 45 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Femmina
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
Altri nomi:
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Sperimentale: 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.
|
Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.
Altri nomi:
|
|
Nessun intervento: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Caries prevalence assessment in pregnant womens
Lasso di tempo: 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.
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Basal measurement, at the beginning of the third trimester of gestation.
|
|
Streptococcus mutans levels identified in pregnant womens
Lasso di tempo: 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.
|
Basal measurement, at the beginning of the third trimester of gestation.
|
|
Streptococcus mutans levels identified in pregnant womens
Lasso di tempo: 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.
|
Three months after the birth of the child.
|
|
Streptococcus mutans levels identified in pregnant womens
Lasso di tempo: 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.
|
Six months after the birth of the child
|
|
Genotypes of the isolates of S. mutans in pregnant womens.
Lasso di tempo: 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.
|
Three months after the birth of the child.
|
|
Streptococcus mutans levels identified in childrens
Lasso di tempo: 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.
|
Three months after the birth of the child.
|
|
Streptococcus mutans levels identified in children
Lasso di tempo: 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.
Lasso di tempo: 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.
|
Three months after the birth of the child.
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
1 gennaio 2015
Completamento primario (Effettivo)
1 ottobre 2017
Completamento dello studio (Effettivo)
1 dicembre 2017
Date di iscrizione allo studio
Primo inviato
14 aprile 2021
Primo inviato che soddisfa i criteri di controllo qualità
27 aprile 2021
Primo Inserito (Effettivo)
3 maggio 2021
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
3 maggio 2021
Ultimo aggiornamento inviato che soddisfa i criteri QC
27 aprile 2021
Ultimo verificato
1 aprile 2021
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Oral health promotion
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Sì
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
Sì
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