Clinical trial NCT04868513: Streptococcus Mutans Reduction Early Mother-infant Transmission
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pregnant Women
Keywords: chlorhexidine varnish
silane fluoride
Streptococcus mutans
vertical transmission
Lead sponsor: Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random clinical trial of parallel groups
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Caries prevalence assessment in pregnant womens
timeFrame: Basal measurement, at the beginning of the third trimester of gestation.
measure: Streptococcus mutans levels identified in pregnant womens
timeFrame: Basal measurement, at the beginning of the third trimester of gestation.
measure: Streptococcus mutans levels identified in pregnant womens
timeFrame: Three months after the birth of the child.
measure: Streptococcus mutans levels identified in pregnant womens
timeFrame: Six months after the birth of the child
measure: Genotypes of the isolates of S. mutans in pregnant womens.
timeFrame: Three months after the birth of the child.
measure: Streptococcus mutans levels identified in childrens
timeFrame: Three months after the birth of the child.
measure: Streptococcus mutans levels identified in children
timeFrame: Six months after the birth of the child.
measure: Genotypes of the isolates of S. mutans in children.
timeFrame: Three months after the birth of the child.
Secondary outcomes:
Other outcomes:
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