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NCT04298996 Clinical Trial

Effect of Passive Smoking on Oxidative Stress and Dental Caries in Children

Dental Caries Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04298996
Other study ID # 2016-140
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2016
Est. completion date August 15, 2018

Study information
Verified date March 2020
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of the present study was to determine the effect of passive smoking on oxidative stress and dental caries in children.A total of 180 children were included to the study as follows; 90 children exposed to passive smoking, and 90 children in the control group (unexposed controls). Also demographic data were recorded (age, gender, parental education levels, child's tooth-brushing habit and child's daily dietary sugar exposure, family income). Dental examination of children were performed and caries prevalence of the patients were recorded. Unstimulated saliva samples were collected from children. Saliva 'cotinine levels' and oxidative stress markers 'total antioxidant status' (TAS), and' total oxidant status' (TOS) were evaluated by using Enzyme-linked immunosorbent assay (ELISA). The obtained data parameters of the two groups were evaluated and comparison was performed.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date August 15, 2018
Est. primary completion date April 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

-Systemically healthy children

Exclusion Criteria:

- Uncooperative children

- The presence of orthodontic/intraoral appliance

- Any disease or condition known to affect oxidative stress

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• taking saliva samples to determine oxidative stress markers TAS and TOS

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Merve Erkmen Almaz Kirikkale University

Outcome
Type Measure Description Time frame Safety issue
Primary determining oxidative stress marker in saliva: TAS Unstimulated saliva samples were collected from children. 1 day (once after the dental examination)]
Primary determining oxidative stress marker in saliva: TOS Unstimulated saliva samples were collected from children. 1 day (once after the dental examination)
Primary determining caries prevalence Children were examined to determine caries prevalence. 1 day (once for dental examination)
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