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

March 5, 2020 updated by: Merve Erkmen Almaz
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.

Study Overview

Study Type

Observational

Enrollment (Actual)

180

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

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children, referring for dental examination to the Department of Pediatric Dentistry of Kirikkale University, were selected.

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group (passive smoking children)
examining for caries prevalence and taking saliva samples to determine oxidative stress markers TAS and TOS
control group
examining for caries prevalence and taking saliva samples to determine oxidative stress markers TAS and TOS

What is the study measuring?

Primary Outcome Measures

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

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 (ACTUAL)

November 16, 2016

Primary Completion (ACTUAL)

April 15, 2018

Study Completion (ACTUAL)

August 15, 2018

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 4, 2020

First Posted (ACTUAL)

March 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2020

Last Update Submitted That Met QC Criteria

March 5, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2016-140

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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