Streptococcus MutansNCT04228861
Investigation of Oral Microflora of Infants
An observational study of Streptococcus Mutans, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The placement of cariogenic microorganisms in oral microflora is an important factor in dental caries. The aim of this study is to research from whom, when and how the cariogenic microorganisms are first transmitted to the infant. Read more about this study
- Who is it for?
- Ages 30 minutes to 2 hoursHealthy volunteers can take part
- Conditions the study is for
- Streptococcus Mutans
- How many people
- 47 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 25 Jan 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 30 minutes to 2 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study was conducted in two centers - Turgut Özal Medical Center and Malatya Training and Research Hospital. Between January and May 2018, healthy newborns born in these two hospitals were followed up.
Who may be able to join
- none of the infants or their families had systemic disease
Who cannot join
- the infants or their families have systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Colonization of Streptococcus Mutans, Lactobacillus Spp. and Candida Spp. in Oral Microflora in Infancy and Transmission From the Parent to the Infant
The placement of cariogenic microorganisms in oral microflora is an important factor in dental caries. The aim of this study is to research from whom, when and how the cariogenic microorganisms are first transmitted to the infant. The investigators investigated of colonization of Streptococcus mutans, Lactobacillus spp., and Candida spp. in oral cavities of infants and their transmission to the infants.
Read the detailed description
Study sample size and design: When α = 0.05, 1-β (power) = 0.80 were taken to determine the sample volume, it was calculated that at least 46 babies should be sampled for 6 months to have an average amount of S. mutans change of 1.87 units. Considering the losses that may occur during the follow-up, the study was started by taking samples from 60 systemically healthy newborns.
The study commenced with 60 newborns and was completed with 47 infants due to losses during the follow-up. Oral swab samples were taken from 47 healthy infants within the first 24 hours after birth, at 1 month old and during the first tooth eruption. Saliva samples were taken from the mothers of all the infants and from the fathers of 20 of the infants in the last meeting.
Last interview with the parents, their oral examinations were performed, and their findings were processed as decayed (D), filled (F) and missing (M) teeth in accordance with the World Health Organization criteria, with the DMF (decayed, missing and filled) index being calculated. Furthermore, saliva samples were taken from the parents at the last interview. A questionnaire form including the sex of the infant, type of delivery, birth weight, and nutritional habits of the infant during the follow-up was filled in by gaining information from the parents on the first day and during the follow-ups.
Swab samples taken from infants with sterile swabs were transferred to the laboratory by placing sterile saline solution into dispensed 2 ml screw cap tubes. Sterile urine collection containers of 50 ml were used to collect saliva samples from the parents.
- Conditions
- Streptococcus Mutans
- Keywords
- Familial transmission, Candida, Lactobacillus, S. mutans, newborn
- Medical subject headings
- Torulopsis
What is being measured
The primary outcome is the main question the study is designed to answer.
Acquisition of the oral streptococcus mutans in infants
Counts of oral streptococcus mutans
Measured: first 24 hours after birth
Acquisition of the oral streptococcus mutans in infants
Counts of oral streptococcus mutans
Measured: at 1 month old
Acquisition of the oral streptococcus mutans in infants
Counts of oral streptococcus mutans
Measured: 4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby
Secondary outcomes (3)
Acquisition of the oral Lactobacillus and candida spp. in infants
Counts of oral Lactobacillus and candida spp
Measured: first 24 hours after birth
Acquisition of the oral Lactobacillus and candida spp. in infants
Counts of oral Lactobacillus and candida spp
Measured: at 1 month old
Acquisition of the oral Lactobacillus and candida spp. in infants
Counts of oral Lactobacillus and candida spp
Measured: 4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Jan 2018
- Primary completion20 May 2018
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Streptococcus MutansStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Beyza Erel, Inonu University
- Investigators
- gülsüm duruk, Study director, Inonu Universityzehra b erel, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228861
- Sponsor's protocol ID
- 963
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: I can think of sharing after becoming a publication in a journal
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Colonization of Streptococcus Mutans, Lactobacillus Spp. and Candida Spp. in Oral Microflora in Infancy and Transmission From the Parent to the Infant
- ClinicalTrials.gov ID
- NCT04228861
- Acronym / sponsor ID
- 963
- Conditions
- Streptococcus Mutans
- Keywords
- Familial transmission, Candida, Lactobacillus, S. mutans, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 20 May 2018 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 14 Jan 2020 (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.
The placement of cariogenic microorganisms in oral microflora is an important factor in dental caries. The aim of this study is to research from whom, when and how the cariogenic microorganisms are first transmitted to the infant. The investigators investigated of colonization of Streptococcus mutans, Lactobacillus spp., and Candida spp. in oral cavities of infants and their transmission to the infants.
Detailed description
Study sample size and design: When α = 0.05, 1-β (power) = 0.80 were taken to determine the sample volume, it was calculated that at least 46 babies should be sampled for 6 months to have an average amount of S. mutans change of 1.87 units. Considering the losses that may occur during the follow-up, the study was started by taking samples from 60 systemically healthy newborns.
The study commenced with 60 newborns and was completed with 47 infants due to losses during the follow-up. Oral swab samples were taken from 47 healthy infants within the first 24 hours after birth, at 1 month old and during the first tooth eruption. Saliva samples were taken from the mothers of all the infants and from the fathers of 20 of the infants in the last meeting.
Last interview with the parents, their oral examinations were performed, and their findings were processed as decayed (D), filled (F) and missing (M) teeth in accordance with the World Health Organization criteria, with the DMF (decayed, missing and filled) index being calculated. Furthermore, saliva samples were taken from the parents at the last interview. A questionnaire form including the sex of the infant, type of delivery, birth weight, and nutritional habits of the infant during the follow-up was filled in by gaining information from the parents on the first day and during the follow-ups.
Swab samples taken from infants with sterile swabs were transferred to the laboratory by placing sterile saline solution into dispensed 2 ml screw cap tubes. Sterile urine collection containers of 50 ml were used to collect saliva samples from the parents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 30 minutes to 2 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study was conducted in two centers - Turgut Özal Medical Center and Malatya Training and Research Hospital. Between January and May 2018, healthy newborns born in these two hospitals were followed up.
Key inclusion criteria (1 listed)
- none of the infants or their families had systemic disease
Key exclusion criteria (1 listed)
- the infants or their families have systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acquisition of the oral streptococcus mutans in infants
Time frame: first 24 hours after birth
Counts of oral streptococcus mutans
Acquisition of the oral streptococcus mutans in infants
Time frame: at 1 month old
Counts of oral streptococcus mutans
Acquisition of the oral streptococcus mutans in infants
Time frame: 4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby
Counts of oral streptococcus mutans
3 secondary outcomes
Acquisition of the oral Lactobacillus and candida spp. in infants
Time frame: first 24 hours after birth
Acquisition of the oral Lactobacillus and candida spp. in infants
Time frame: at 1 month old
Acquisition of the oral Lactobacillus and candida spp. in infants
Time frame: 4 to 12 months depending on the first tooth eruption.This period changed according to the growth rate of the baby
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 18 Jan 2020.
- Individual participant dataSharing planned: Undecided. I can think of sharing after becoming a publication in a journal
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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.
gülsüm duruk study director
Inonu University
zehra b erel principal investigator
Inonu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Streptococcus Mutans, run by Inonu University at 1 site in Turkey (Türkiye).
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 1 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 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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?
Acquisition of the oral streptococcus mutans in infants (time frame: first 24 hours after birth). The study lists 3 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 18 Jan 2020.