NCT04868513

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Pregnant Women

Interventions

Type	Name	Description
DRUG	Pregnant women to whom applied silane fluoride	Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
DRUG	Pregnant women to whom applied silane fluoride + 1% chlorhexidine	Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2021-05-03
• Last updated: 2021-05-03

Regulatory

• FDA-regulated drug study