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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04292548
Other study ID # Kirikkale pediatric dentistry
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 16, 2016
Est. completion date August 15, 2018

Study information

Verified date February 2020
Source Kirikkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date August 15, 2018
Est. primary completion date April 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
taking saliva samples to determine TAS, TOS and LL-37


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Merve Erkmen Almaz Kirikkale University

Outcome

Type Measure Description Time frame Safety issue
Primary salivary oxidative stress values: TAS level Unstimulated saliva samples were collected from children. 1 day (once after the dental examination)
Primary salivary oxidative stress values: TOS level Unstimulated saliva samples were collected from children. 1 day (once after the dental examination)
Primary salivary LL-37 level Unstimulated saliva samples were collected from children. 1 day (once after the dental examination)
Primary salivary cotinine levels Unstimulated saliva samples were collected from children for describing passive smoking children. 1 day (once after the dental examination)
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