- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03563469
Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth
June 19, 2018 updated by: Joanna Nassef William Samuel, Cairo University
Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth: A Cross Sectional Study
Black stains (BS) are type of extrinsic discoloration of the tooth.
It's characterized as dark lines or an incomplete coalescence of dark dots found mostly on cervical third of the crown.
Most studies worldwide found that children with the black stained teeth have low caries prevalence.
A study on Brazilian population also suggested that black stains might be protective factor against development of dental caries.
A study reported that chromogenic bacteria were proposed as etiological factor in production of black stains.The most common microbiological composition of BS was found to be Actinomycetes.
Dental examination and saliva samples collection will be done for black stained teeth children of outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University.
This research adopts null hypothesis; it assumes that there is no effect on dental caries experience in children with black stained teeth.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
73
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Egyptian children 4-6 years old with black stained teeth.
Description
Inclusion Criteria:
- Patients with black stained teeth who were reported to outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University ranging in age between 4-6 years.
- With primary dentition.
- Both sexes will be included.
- Cooperative children.
Exclusion Criteria:
- Having oral disease (such as peridotites, salivary gland disorder, and oral mucosal disease).
- Having autoimmune disease.
- Receiving any antibiotic treatment in the past three months.
- Parents refuse to sign the consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary bacterial level
Time Frame: 6 months
|
salivary sample collection by passive drooling
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dental caries experience
Time Frame: 6 months
|
The dental caries of all patients will also be recorded using dental mirror and explorer.
The caries experience will be recorded in diagnostic chart using the World Health Organization (WHO) criteria for deciduous teeth and dmft caries index
|
6 months
|
Salivary pH level
Time Frame: 6 months
|
salivary sample collection and measured by the pH meter
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2018
Primary Completion (Anticipated)
July 1, 2019
Study Completion (Anticipated)
September 1, 2019
Study Registration Dates
First Submitted
June 9, 2018
First Submitted That Met QC Criteria
June 19, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
June 20, 2018
Last Update Submitted That Met QC Criteria
June 19, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2015-02-26
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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