Streptococcus Mutans Reduction Early Mother-infant Transmission

Pregnant Women Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04868513
• Other study ID #: Oral health promotion
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: December 2017

Study information

• Verified date: April 2021
• Source: Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnant Women

Intervention

Drug:
• Pregnant women to whom applied silane fluoride
Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
• Pregnant women to whom applied silane fluoride + 1% chlorhexidine
Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries prevalence assessment in pregnant womens	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.	Basal measurement, at the beginning of the third trimester of gestation.
Primary	Streptococcus mutans levels identified in pregnant womens	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.
Primary	Streptococcus mutans levels identified in pregnant womens	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.
Primary	Streptococcus mutans levels identified in pregnant womens	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
Primary	Genotypes of the isolates of S. mutans in pregnant womens.	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.
Primary	Streptococcus mutans levels identified in childrens	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.
Primary	Streptococcus mutans levels identified in children	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.
Primary	Genotypes of the isolates of S. mutans in children.	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.