Investigation of Supragingival Plaque Microbiome in Early Childhood Caries

Completed

• Conditions: Early Childhood Caries
• Interventions: Genetic: Collection of supragingival plaque from caries free children

• Registration Number: NCT04456335
• Lead Sponsor: Trakya University

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.

Study Timeline

• Study Start: 2019-03-04
• Primary Completion: 2020-01-03
• Study Completion: 2020-05-23
• Status Verified: 2020-06
• Study First Submitted: 2020-06-18
• Study First Submitted QC: 2020-06-29
• Last Update Submitted: 2020-06-29
• Study First Posted: 2020-07-02
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Caries-free	Collection of supragingival plaque from caries free children	Caries-free children
Early childhood caries	Collection of supragingival plaque from caries free children	Children with early childhood caries

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry; 🇹🇷 Edirne, Turkey