Streptococcus Mutans Reduction Early Mother-infant Transmission
27 de abril de 2021 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
58
Fase
- Fase 4
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 45 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
Otros nombres:
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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.
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Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.
Otros nombres:
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Sin intervención: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Caries prevalence assessment in pregnant womens
Periodo de tiempo: 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
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Three months after the birth of the child.
|
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Streptococcus mutans levels identified in children
Periodo de tiempo: 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.
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Genotypes of the isolates of S. mutans in children.
Periodo de tiempo: 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, 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2015
Finalización primaria (Actual)
1 de octubre de 2017
Finalización del estudio (Actual)
1 de diciembre de 2017
Fechas de registro del estudio
Enviado por primera vez
14 de abril de 2021
Primero enviado que cumplió con los criterios de control de calidad
27 de abril de 2021
Publicado por primera vez (Actual)
3 de mayo de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de mayo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
27 de abril de 2021
Última verificación
1 de abril de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Oral health promotion
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Sí
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
Sí
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