NCT04298996

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
Last Updated

March 9, 2020

Status Verified

March 1, 2020

Enrollment Period

1.4 years

First QC Date

March 4, 2020

Last Update Submit

March 5, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • determining oxidative stress marker in saliva: TAS

    Unstimulated saliva samples were collected from children.

    1 day (once after the dental examination)]

  • determining oxidative stress marker in saliva: TOS

    Unstimulated saliva samples were collected from children.

    1 day (once after the dental examination)

  • determining caries prevalence

    Children were examined to determine caries prevalence.

    1 day (once for dental examination)

Study Arms (2)

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

control groupstudy group (passive smoking children)

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Systemically healthy children

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assist prof

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 6, 2020

Study Start

November 16, 2016

Primary Completion

April 15, 2018

Study Completion

August 15, 2018

Last Updated

March 9, 2020

Record last verified: 2020-03