Streptococcus Mutans Reduction Early Mother-infant Transmission
27. April 2021 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
58
Phase
- Phase 4
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 45 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
|
Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
Andere Namen:
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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.
|
Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.
Andere Namen:
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Kein Eingriff: 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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Caries prevalence assessment in pregnant womens
Zeitfenster: 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.
|
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Streptococcus mutans levels identified in pregnant womens
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
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Three months after the birth of the child.
|
|
Streptococcus mutans levels identified in childrens
Zeitfenster: 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
Zeitfenster: 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.
Zeitfenster: 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.
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. Januar 2015
Primärer Abschluss (Tatsächlich)
1. Oktober 2017
Studienabschluss (Tatsächlich)
1. Dezember 2017
Studienanmeldedaten
Zuerst eingereicht
14. April 2021
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
27. April 2021
Zuerst gepostet (Tatsächlich)
3. Mai 2021
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
3. Mai 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. April 2021
Zuletzt verifiziert
1. April 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- Oral health promotion
Plan für individuelle Teilnehmerdaten (IPD)
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NEIN
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Ja
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Ja
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