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

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.

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

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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