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Clinical Trials/NCT04456335
NCT04456335
Completed
Not Applicable

Investigation of Supragingival Plaque Microbiome Using Next Generation Sequencing in Early Childhood Caries

Trakya University1 site in 1 country60 target enrollmentMarch 4, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Early Childhood Caries
Sponsor
Trakya University
Enrollment
60
Locations
1
Primary Endpoint
V4-16S rRNA and ITS1 rRNA sequencing
Status
Completed
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
March 4, 2019
End Date
May 23, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

ŞİRİN GÜNER ONUR

Assist. Prof. Dr.

Trakya University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

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