Streptococcus Mutans Reduction Early Mother-infant Transmission

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.

Study Overview

• Status: Completed
• Conditions: Pregnant Women
• Intervention / Treatment: Drug: Pregnant women to whom applied silane fluoride; Drug: Pregnant women to whom applied silane fluoride + 1% chlorhexidine

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Pregnant women to whom applied silane fluoride; Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.; Other Names: Fluor Protector, Ivoclar Vivadent AG™
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.	Drug: Pregnant women to whom applied silane fluoride + 1% chlorhexidine; Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.; Other Names: Fluor Protector, Ivoclar Vivadent AG™ + 1% chlorhexidine
No Intervention: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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
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.
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.
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.
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.

Collaborators and Investigators

• Sponsor: Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: April 14, 2021
• First Submitted That Met QC Criteria: April 27, 2021
• First Posted (Actual): May 3, 2021

Study Record Updates

• Last Update Posted (Actual): May 3, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: vertical transmission; Streptococcus mutans; chlorhexidine varnish; silane fluoride
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Dermatologic Agents; Cariostatic Agents; Disinfectants; Fluorides; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: Oral health promotion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes