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CompletedNCT04298996Updated Mar 9, 2020

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

An observational study in Oxidative Stress, Dental Caries and Passive Smoking, sponsored by Merve Erkmen Almaz. Completed. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-09.

Sponsored by Merve Erkmen Almaz · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
180
Ages
6 Years to 12 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Oxidative Stress
  • Dental Caries
  • Passive Smoking

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 180 is close to the median of 180 across 177 observational studies indexed under Dental Caries.

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Lead sponsor

Merve Erkmen Almaz is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

-Systemically healthy children

Exclusion criteria

Exclusion Criteria:

  • Uncooperative children
  • The presence of orthodontic/intraoral appliance
  • Any disease or condition known to affect oxidative stress
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
180 participants (actual)
Patient registry
No

Groups and cohorts

  • study group (passive smoking children)

    examining for caries prevalence and taking saliva samples to determine oxidative stress markers TAS and TOS

    Diagnostic Test: 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

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

Interventions

  • Diagnostic testtaking saliva samples to determine oxidative stress markers TAS and TOS
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What researchers measure

Primary outcomes

  1. determining oxidative stress marker in saliva: TAS

    Unstimulated saliva samples were collected from children.

    Time frame: 1 day (once after the dental examination)]

  2. determining oxidative stress marker in saliva: TOS

    Unstimulated saliva samples were collected from children.

    Time frame: 1 day (once after the dental examination)

  3. determining caries prevalence

    Children were examined to determine caries prevalence.

    Time frame: 1 day (once for dental examination)

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04298996
Lead sponsor
Merve Erkmen Almaz
Collaborators
Kırıkkale University
Responsible party
Merve Erkmen Almaz (Assist prof, Kırıkkale University) — Sponsor-investigator
First posted
Mar 6, 2020
Start date
Nov 16, 2016
Primary completion
Apr 15, 2018
Completion
Aug 15, 2018
Last update
Mar 9, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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