Investigation of Supragingival Plaque Microbiome in Early Childhood Caries

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.

Study Overview

• Status: Completed
• Conditions: Early Childhood Caries
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Turkey
  • Edirne, Turkey, 22030
    • Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 4 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of sixty children with early childhood caries(n=30) and caries free(n=30)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Collaborators and Investigators

• Sponsor: Trakya University
• Collaborators: Commission of Scientific Research Projects of Trakya University (TÜBAP)

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): January 3, 2020
• Study Completion (Actual): May 23, 2020

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 29, 2020
• First Posted (Actual): July 2, 2020

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 29, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Early childhood caries; Next generation sequencing; Oral Microbiome
• Other Study ID Numbers: 2018/269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No