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Investigation of Supragingival Plaque Microbiome in Early Childhood Caries

Sponsor
Trakya University (Other)
Overall Status
Completed
CT.gov ID
NCT04456335
Collaborator
Commission of Scientific Research Projects of Trakya University (TÜBAP) (Other)
60
Enrollment
1
Location
14.7
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Collection of supragingival plaque from caries free children

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

Study Type:
Observational
Actual Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official Title:
Investigation of Supragingival Plaque Microbiome Using Next Generation Sequencing in Early Childhood Caries
Actual Study Start Date :
Mar 4, 2019
Actual Primary Completion Date :
Jan 3, 2020
Actual Study Completion Date :
May 23, 2020

Arms and Interventions

Arm Intervention/Treatment
Caries-free

Caries-free children

Genetic: Collection of supragingival plaque from caries free children
Supragingival plaque samples were collected from posterior molar teeth
Other Names:
  • Collection of supragingival plaque from children with early childhood caries

    		•
    Early childhood caries

    Children with early childhood caries

    Genetic: Collection of supragingival plaque from caries free children
    Supragingival plaque samples were collected from posterior molar teeth
    Other Names:
  • Collection of supragingival plaque from children with early childhood caries

    		•

    Outcome Measures

    Primary Outcome Measures

    1. V4-16S rRNA and ITS1 rRNA sequencing [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    36 Months to 71 Months
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry Edirne Turkey 22030

    Sponsors and Collaborators

    • Trakya University
    • Commission of Scientific Research Projects of Trakya University (TÜBAP)

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ŞİRİN GÜNER ONUR, Assist. Prof. Dr., Trakya University
    ClinicalTrials.gov Identifier:
    NCT04456335
    Other Study ID Numbers:
    • 2018/269
    First Posted:
    Jul 2, 2020
    Last Update Posted:
    Jul 2, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by ŞİRİN GÜNER ONUR, Assist. Prof. Dr., Trakya University
    Early childhood caries
    Oral Microbiome
    Next generation sequencing

    Study Results

    No Results Posted as of Jul 2, 2020