Dental Plaque Microbiota in Caries-free and Caries-active Children

NCT ID: NCT03906981

Last Updated: 2019-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2019-04-01

Brief Summary

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Dental caries is a polymicrobial infection originally thought to be caused by Streptococcus mutans and Lactobacilli. However, unprecedented developments in modern molecular techniques have demonstrated that several microbial species are associated with the disease in addition to streptococci and lactobacilli. Dental caries initiation and progression is a dynamic process in which demineralization of the tooth structure, as a result of acid production from acidogenic bacteria (due to carbohydrate metabolism) is being counteracted by the remineralization of the tooth surface by strong alkali production by certain bacteria in the dental biofilm. The aim of the present study is to identify the different microbiota in the oral biofilm using new laboratory techniques as well as the levels of salivary proteins in caries-free compared with caries active Arab children.

Detailed Description

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The objective of this study will be to investigate the dental plaque's microbial diversity using Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) technology in the mixed dentition as well as the levels of salivary proteins in caries-free compared with caries active Arab children. The study protocol was approved by the Health Science Center Ethical Committee at Kuwait University.

One hundred 6-9 year-old children with caries active and caries-free status will be recruited from randomly selected public schools in Kuwait. After DNA purification from supragingival plaque samples, HOMINGS will be performed. To get an insight into the host factors involved in this complex interplay between the host and the bacteria, stimulated saliva from the study subjects will be analyzed by proteomics. For children in both groups supragingival plaque samples will be collected from the buccal and lingual surfaces of all teeth. After preparing the samples, the aliquots of purified DNA samples will be shipped to The Forsyth Institute for Human Oral Microbe Identification using Next Generation Sequencing (HOMINGS) protocol.

Conditions

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Caries Plaque

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Caries free

6-9 year old caries free children

Plaque from each subject will be collected but there will be no intervention

Intervention Type OTHER

No intervention

Caries active

6-9 year-old caries active (\>5 dmft/DMFT) children

Plaque from each subject will be collected but there will be no intervention

Intervention Type OTHER

No intervention

Interventions

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Plaque from each subject will be collected but there will be no intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Arab 6-9 year old children
* Healthy
* Caries free, dmft/DMFT=0
* Caries Active: dmft/DMFT\>5

Exclusion Criteria

* Children with a systemic disease or any drug use that could affect the microflora of the oral cavity or the salivary gland functions
* History of salivary gland diseases
* Those who received antibiotic therapy during the last 3 months
* Children with severe localized or generalized periodontitis.
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kuwait University

OTHER

Sponsor Role lead

Responsible Party

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Muawia A. Qudeimat

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Muawia A Qudeimat, MDentSci

Role: PRINCIPAL_INVESTIGATOR

Kuwait University

Other Identifiers

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DD01/14

Identifier Type: -

Identifier Source: org_study_id

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