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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03563469
Other study ID # CEBD-CU-2015-02-26
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date September 1, 2019

Study information

Verified date June 2018
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 73
Est. completion date September 1, 2019
Est. primary completion date July 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 6 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Salivary bacterial and pH level
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. 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary Salivary bacterial level salivary sample collection by passive drooling 6 months
Secondary Dental caries experience 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
Secondary Salivary pH level salivary sample collection and measured by the pH meter 6 months