- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04292548
Salivary TAS, TOS, LL-37 and Dental Status in Passive Smoking Children
March 2, 2020 updated by: Merve Erkmen Almaz
The aim of the present study was to determine the effect of passive smoking on the levels of salivary TAS, TOS, LL-37 and dental status in children.In the study the parents of children were asked to fill out a complete survey about smoking habits.
After filling out the questionnaire, according to the survey results, 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 prevalance of the patients were recorded.
Unstimulated saliva samples were collected from children.
Saliva 'cotinine levels' which are expected to increase in passive smoking group; 'antimicrobial peptide LL-37' 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:
- The presence of orthodontic / intraoral appliance
- Any disease or condition known to affect defense system
- Uncooperative children
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 |
---|---|
control group
|
|
study group (passive smoking children)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
salivary oxidative stress values: TAS level
Time Frame: 1 day (once after the dental examination)
|
Unstimulated saliva samples were collected from children.
|
1 day (once after the dental examination)
|
salivary oxidative stress values: TOS level
Time Frame: 1 day (once after the dental examination)
|
Unstimulated saliva samples were collected from children.
|
1 day (once after the dental examination)
|
salivary LL-37 level
Time Frame: 1 day (once after the dental examination)
|
Unstimulated saliva samples were collected from children.
|
1 day (once after the dental examination)
|
salivary cotinine levels
Time Frame: 1 day (once after the dental examination)
|
Unstimulated saliva samples were collected from children for describing passive smoking children.
|
1 day (once after the 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
February 28, 2020
First Submitted That Met QC Criteria
March 2, 2020
First Posted (ACTUAL)
March 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 3, 2020
Last Update Submitted That Met QC Criteria
March 2, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Kırıkkale pediatric dentistry
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
As soon as possible data will be shared when it is published in a journal.
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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