Investigation of Supragingival Plaque Microbiome in Early Childhood Caries

Early Childhood Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04456335
• Other study ID #: 2018/269
• Status: Completed
• Start date: March 4, 2019
• Est. completion date: May 23, 2020

Study information

• Verified date: June 2020
• Source: Trakya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 23, 2020
• Est. primary completion date: January 3, 2020
• Gender: All
• Age group: 36 Months to 71 Months

Eligibility

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

Related Conditions & MeSH terms

• Early Childhood Caries

Intervention

Genetic:
• Collection of supragingival plaque from caries free children
Supragingival plaque samples were collected from posterior molar teeth

Locations

Country	Name	City	State
Turkey	Trakya Universitiy Faculty of Dentistry Department of Pediatric Dentistry	Edirne

Sponsors (2)

Lead Sponsor	Collaborator
Trakya University	Commission of Scientific Research Projects of Trakya University (TÜBAP)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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