Early Childhood CariesNCT04456335
Investigation of Supragingival Plaque Microbiome in Early Childhood Caries
An observational study of Early Childhood Caries, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to characterize the supragingival plaque microbiome in children with early childhood caries and identify potential microorganisms associated with caries. Read more about this study
- Who is it for?
- Ages 36 to 71 months
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Collection of supragingival plaque from caries free children
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Mar 2019to 23 May 2020
- 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 36 to 71 months
- All sexes
- Child
Study population: A total of sixty children with early childhood caries(n=30) and caries free(n=30)
Who may be able to join
- 36-71 months old children
- No history of any medical problem
- No history of antibiotic in the three months prior to sampling
- Any sign of early childhood caries,
- Caries free children
- Mothers accepted to complete a structured questionnaire
- Children who cooperate for dental examination and sample collection
Who cannot join
- Children older than 71 months
- Medically compromised
- Children with antibiotic use history at last three months
- Children refused dental examination and plaque collection
- Mothers' refused to complete questionnare
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry
Edirne, 22030
About this study
Official title: Investigation of Supragingival Plaque Microbiome Using Next Generation Sequencing in Early Childhood Caries
The purpose of this study was to characterize the supragingival plaque microbiome in children with early childhood caries and identify potential microorganisms associated with caries.
Read the detailed description
Sixty children with and without early childhood caries were recruited from Trakya University Faculty of Dentistry Department of Pediatric Dentistry. Oral examinations were performed by the same examiner according to diagnostic criteria of World Health Organisation (WHO) and The International Caries Detection and Assessment System (ICDAS) . Mothers' completed a structured questionnaire on the socio-demographic informations, child's feeding practices and oral hygiene habits. After the oral examination, supragingival plaque samples were collected from the posterior tooth surfaces. Supragingival plaque samples were examined with the Illumina MiSeq new generation sequencing method.
- Conditions
- Early Childhood Caries
- Being tested
- Collection of supragingival plaque from caries free children
- Keywords
- Early childhood caries, Oral Microbiome, Next generation sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of supragingival plaque from caries free childrenGenetic
Also called Collection of supragingival plaque from children with early childhood caries
Supragingival plaque samples were collected from posterior molar teeth
| Study group | Role | What they receive |
|---|---|---|
| Caries-free | Caries-free children Receives: Genetic: Collection of supragingival plaque from caries free children | |
| Early childhood caries | Children with early childhood caries Receives: Genetic: Collection of supragingival plaque from caries free children |
What is being measured
The primary outcome is the main question the study is designed to answer.
V4-16S rRNA and ITS1 rRNA sequencing
Supragingival plaque samples were collected from the tooth surfaces using a sterile periodontal curette. DNA extraction was performed at Sugenomik Biotechnology Laboratory for library preparation and paired-end Illumina MiSeq PE250 sequencing of the V4 region of bacterial 16S rRNA and fungal ITS1 (internal transcribed spacer 1) rRNA genes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start4 Mar 2019
- Primary completion3 Jan 2020
- Study completion23 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Childhood CariesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞİRİN GÜNER ONUR, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04456335
- Sponsor's protocol ID
- 2018/269
- Status last verified
- Jun 2020
- First submitted
- 18 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Supragingival Plaque Microbiome Using Next Generation Sequencing in Early Childhood Caries
- ClinicalTrials.gov ID
- NCT04456335
- Acronym / sponsor ID
- 2018/269
- Conditions
- Early Childhood Caries
- Keywords
- Early childhood caries, Oral Microbiome, Next generation sequencing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 3 Jan 2020 (actual)
- Study completion
- 23 May 2020 (actual)
- First posted
- 2 Jul 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 purpose of this study was to characterize the supragingival plaque microbiome in children with early childhood caries and identify potential microorganisms associated with caries.
Detailed description
Sixty children with and without early childhood caries were recruited from Trakya University Faculty of Dentistry Department of Pediatric Dentistry. Oral examinations were performed by the same examiner according to diagnostic criteria of World Health Organisation (WHO) and The International Caries Detection and Assessment System (ICDAS) . Mothers' completed a structured questionnaire on the socio-demographic informations, child's feeding practices and oral hygiene habits. After the oral examination, supragingival plaque samples were collected from the posterior tooth surfaces. Supragingival plaque samples were examined with the Illumina MiSeq new generation sequencing method.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Caries-free | – | Genetic: Collection of supragingival plaque from caries free childrenCaries-free children |
| Early childhood caries | – | Genetic: Collection of supragingival plaque from caries free childrenChildren with early childhood caries |
Who may qualify
- Ages
- 36 to 71 months
- Sex
- All
- Age groups
- Child
- Study population
- A total of sixty children with early childhood caries(n=30) and caries free(n=30)
Key inclusion criteria (7 listed)
- 36-71 months old children
- No history of any medical problem
- No history of antibiotic in the three months prior to sampling
- Any sign of early childhood caries,
- Caries free children
Key exclusion criteria (5 listed)
- Children older than 71 months
- Medically compromised
- Children with antibiotic use history at last three months
- Children refused dental examination and plaque collection
- Mothers' refused to complete questionnare
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 |
|---|---|---|
| Collection of supragingival plaque from caries free childrenAlso: Collection of supragingival plaque from children with early childhood cariesSupragingival plaque samples were collected from posterior molar teeth | Genetic | Caries-free, Early childhood caries |
Primary outcome
V4-16S rRNA and ITS1 rRNA sequencing
Time frame: 6 months
Supragingival plaque samples were collected from the tooth surfaces using a sterile periodontal curette. DNA extraction was performed at Sugenomik Biotechnology Laboratory for library preparation and paired-end Illumina MiSeq PE250 sequencing of the V4 region of bacterial 16S rRNA and fungal ITS1 (internal transcribed spacer 1) rRNA genes.
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 2 Jul 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Early Childhood Caries, run by Trakya 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 7 inclusion and 5 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 2 Jul 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?
V4-16S rRNA and ITS1 rRNA sequencing (time frame: 6 months). 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 2 Jul 2020.