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Streptococcus Mutans Reduction Early Mother-infant Transmission

B

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

Status and phase

Completed
Phase 4

Conditions

Pregnant Women

Treatments

Drug: Pregnant women to whom applied silane fluoride
Drug: Pregnant women to whom applied silane fluoride + 1% chlorhexidine

Study type

Interventional

Funder types

Other

Identifiers

NCT04868513
Oral health promotion

Details and patient eligibility

About

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.

Full 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.

Enrollment

58 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

58 participants in 4 patient groups

Pregnant women to whom applied silane fluoride
Experimental group
Description:
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.
Treatment:
Drug: Pregnant women to whom applied silane fluoride
Pregnant women to whom applied silane fluoride + 1% chlorhexidine
Experimental group
Description:
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.
Treatment:
Drug: Pregnant women to whom applied silane fluoride + 1% chlorhexidine
Children of the pregnant women to whom it was applied silane fluoride
No Intervention group
Description:
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 group
Description:
The children not given any intervention, they were only subjected to a microbiological and clinical examination.

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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