Pregnant WomenPhase 4NCT04868513
Streptococcus Mutans Reduction Early Mother-infant Transmission
A Phase 4 study testing Pregnant women to whom applied silane fluoride and Pregnant women to whom applied silane fluoride + 1% chlorhexidine in people with Pregnant Women, run by Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Pregnant women to whom applied silane fluoride and Pregnant women to whom applied silane fluoride + 1% chlorhexidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- -Non-pregnant women
About this study
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
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.
Read the 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
- Being tested
- Pregnant women to whom applied silane fluoride, Pregnant women to whom applied silane fluoride + 1% chlorhexidine
- Keywords
- chlorhexidine varnish, silane fluoride, Streptococcus mutans, vertical transmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pregnant women to whom applied silane fluorideDrug
Also called Fluor Protector, Ivoclar Vivadent AG™
Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
Pregnant women to whom applied silane fluoride + 1% chlorhexidineDrug
Also called Fluor Protector, Ivoclar Vivadent AG™ + 1% chlorhexidine
Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Three months after the birth of the child.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study startJan 2015
- Primary completionOct 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Random clinical trial of parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marine Ortiz Magdaleno, Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04868513
- Sponsor's protocol ID
- Oral health promotion
- Status last verified
- Apr 2021
- First submitted
- 14 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04868513
- Acronym / sponsor ID
- Oral health promotion
- Conditions
- Pregnant Women
- Keywords
- chlorhexidine varnish, silane fluoride, Streptococcus mutans, vertical transmission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis PotUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- Random clinical trial of parallel groups
| Arm | Type | Receives |
|---|---|---|
| Pregnant women to whom applied silane fluoride | Experimental | Drug: Pregnant women to whom applied silane fluorideWe 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. |
| Pregnant women to whom applied silane fluoride + 1% chlorhexidine | Experimental | Drug: Pregnant women to whom applied silane fluoride + 1% chlorhexidineWe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- -Non-pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pregnant women to whom applied silane fluorideAlso: Fluor Protector, Ivoclar Vivadent AG™Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth. | Drug | Pregnant women to whom applied silane fluoride |
| Pregnant women to whom applied silane fluoride + 1% chlorhexidineAlso: Fluor Protector, Ivoclar Vivadent AG™ + 1% chlorhexidinePregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth. | Drug | Pregnant women to whom applied silane fluoride + 1% chlorhexidine |
Primary outcome
Caries prevalence assessment in pregnant womens
Time frame: Basal measurement, at the beginning of the third trimester of gestation.
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.
Streptococcus mutans levels identified in pregnant womens
Time frame: Basal measurement, at the beginning of the third trimester of gestation.
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.
Streptococcus mutans levels identified in pregnant womens
Time frame: Three months after the birth of the child.
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.
Streptococcus mutans levels identified in pregnant womens
Time frame: Six months after the birth of the child
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.
Genotypes of the isolates of S. mutans in pregnant womens.
Time frame: Three months after the birth of the child.
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.
Streptococcus mutans levels identified in childrens
Time frame: Three months after the birth of the child.
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.
Streptococcus mutans levels identified in children
Time frame: Six months after the birth of the child.
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.
Genotypes of the isolates of S. mutans in children.
Time frame: Three months after the birth of the child.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Individual participant dataSharing planned: No
Related trials for Pregnant Women
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruitingPhase 2
Treating Muscle-invasive Bladder Cancer With A Non-surgical Method Consisting of Anti-PD-1 Therapy and Chemoradiation
Muscle-Invasive Bladder Carcinoma, Programmed Cell Death Protein 1 Inhibitor
Not yet recruiting
Ultrasound-Guided Radiofrequency Ablation for Focal Adenomyosis
Adenomyosis, Adenomyoma of Uterus
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pregnant women to whom applied silane fluoride and Pregnant women to whom applied silane fluoride + 1% chlorhexidine in people with Pregnant Women, run by Biochemical and Microbiology Laboratory, Faculty of Dentistry, Autonomous University of San Luis Pot.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries prevalence assessment in pregnant womens (time frame: Basal measurement, at the beginning of the third trimester of gestation.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.