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Trial record 13 of 1199 for:    tooth decay

Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth

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ClinicalTrials.gov Identifier: NCT03563469
Recruitment Status : Not yet recruiting
First Posted : June 20, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Joanna Nassef William Samuel, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment
Black Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth Stains Other: Salivary bacterial and pH level

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 73 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth: A Cross Sectional Study
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Salivary bacterial and pH level
    1. Saliva sample will be collection ask the patient to stop eating and drinking for one hour before collecting the sample,(2) Give the patient distilled water and ask them to rinse their mouth well for 1 min,five minutes after this oral rinse, ask the patient to spit into 50ml sterile tube, collect 5ml of saliva and return to the laboratory within an hour.
    2. 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.
    Other Name: Dental caries experience using dmft caries index


Primary Outcome Measures :
  1. Salivary bacterial level [ Time Frame: 6 months ]
    salivary sample collection by passive drooling


Secondary Outcome Measures :
  1. 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

  2. Salivary pH level [ Time Frame: 6 months ]
    salivary sample collection and measured by the pH meter



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Egyptian children 4-6 years old with black stained teeth.
Criteria

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

Additional Information:

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Responsible Party: Joanna Nassef William Samuel, master student in Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT03563469     History of Changes
Other Study ID Numbers: CEBD-CU-2015-02-26
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dental Caries
Tooth Discoloration
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases