- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03906981
Dental Plaque Microbiota in Caries-free and Caries-active Children
Dental Plaque Microbiota in Caries-free and Caries-active Arab Children
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Caries free
6-9 year old caries free children
|
No intervention
|
|
Caries active
6-9 year-old caries active (>5 dmft/DMFT) children
|
No intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental plaque microbiota profile
Time Frame: 2 months
|
Identification of dental plaque microbiota profile using HOMINGS
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muawia A Qudeimat, MDentSci, Kuwait University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DD01/14
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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