Investigation of Supragingival Plaque Microbiome in Early Childhood Caries

NCT04456335 | Completed DMC

• 1 other identifier: 2018/269
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Childhood Caries

Keywords

Early childhood caries; Oral Microbiome; Next generation sequencing

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Caries-free

Caries-free children

Genetic: Collection of supragingival plaque from caries free children

Early childhood caries

Children with early childhood caries

Genetic: Collection of supragingival plaque from caries free children

Interventions

Collection of supragingival plaque from caries free children GENETIC

Supragingival plaque samples were collected from posterior molar teeth

Also known as: Collection of supragingival plaque from children with early childhood caries

Caries-free; Early childhood caries

Eligibility Criteria

• Age: 36 Months - 71 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry

Edirne, 22030, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Supragingival plaque sample

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assist. Prof. Dr.

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: July 2, 2020
• Study Start: March 4, 2019
• Primary Completion: January 3, 2020
• Study Completion: May 23, 2020
• Last Updated: July 2, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)