Streptococcus Mutans Reduction Early Mother-infant Transmission

NCT04868513 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: Oral health promotion
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pregnant Women

Keywords

chlorhexidine varnish; silane fluoride; Streptococcus mutans; vertical transmission

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (4)

Pregnant women to whom applied silane fluoride

EXPERIMENTAL

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 to whom applied silane fluoride + 1% chlorhexidine

EXPERIMENTAL

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

Children of the pregnant women to whom it was applied silane fluoride

NO INTERVENTION

The children not given any intervention, they were only subjected to a microbiological and clinical examination.

Children of the pregnant women to whom it was applied silane fluoride + 1% chlorhexidine

NO INTERVENTION

The children not given any intervention, they were only subjected to a microbiological and clinical examination.

Interventions

Pregnant women to whom applied silane fluoride DRUG

Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.

Also known as: Fluor Protector, Ivoclar Vivadent AG™

Pregnant women to whom applied silane fluoride

Pregnant women to whom applied silane fluoride + 1% chlorhexidine DRUG

Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.

Also known as: Fluor Protector, Ivoclar Vivadent AG™ + 1% chlorhexidine

Pregnant women to whom applied silane fluoride + 1% chlorhexidine

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: In pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• Non-pregnant women

Sponsors & Collaborators

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

MeSH Terms

Interventions

Fluor Protector; Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research professor

Model Details: Random clinical trial of parallel groups

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: May 3, 2021
• Study Start: January 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share