- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04298996
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
Collaborators
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
Additional Relevant MeSH Terms
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.
Clinical Trials on Dental Caries
-
Ain Shams UniversityCompletedPulpitis | Caries | Caries,Dental | Reversible Pulpitis | Caries Class I | Caries; DentinEgypt
-
Hue University of Medicine and PharmacyRecruitingOcclusal Caries | Caries,Dental | Caries; InitialVietnam
-
University of MinnesotaCompletedUsing Motivational Interviewing To Reduce Parental Risk-Related Behaviors For Early Childhood CariesCaries | Caries,DentalUnited States
-
National University of San Marcos, PeruNot yet recruitingPit and Fissure Caries | Caries,Dental | Sealant DentalPeru
-
3MUniversity of MichiganActive, not recruiting
-
Rawda Hesham Abd ElAzizRecruitingCaries,Dental | Caries Class IIEgypt
-
The University of Texas Health Science Center,...National Institute of Dental and Craniofacial Research (NIDCR)RecruitingCaries,DentalUnited States
-
Federal University of PelotasRecruiting
-
Kompetansesenteret Tannhelse Midt (TkMidt)Karolinska Institutet; University of Bergen; Norwegian University of Science... and other collaboratorsActive, not recruiting
-
Marmara UniversityCompleted
Clinical Trials on taking saliva samples to determine oxidative stress markers TAS and TOS
-
Merve Erkmen AlmazKırıkkale UniversityCompletedDental Caries | Children | Oxidative Stress | Passive Smoking
-
Samara State Medical UniversityRecruitingEndothelial Dysfunction | Cardiotoxicity | Acute Myeloid Leukemia, AdultRussian Federation