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Completed

NCT Number: NCT04456335

Investigation of Supragingival Plaque Microbiome 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.

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Key information

Age range

36 month–71 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry

Edirne, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collection of supragingival plaque from caries free children

Genetic

Supragingival plaque samples were collected from posterior molar teeth

Other names: Collection of supragingival plaque from children with early childhood caries

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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