Salivary TAS, TOS, LL-37 and Dental Status in Passive Smoking Children

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: Dental Caries; Children; Oxidative Stress; Passive Smoking
• Intervention / Treatment: Diagnostic test: taking saliva samples to determine TAS, TOS and LL-37

• Study Type: Observational
• Enrollment (Actual): 180

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
control group	Diagnostic test: taking saliva samples to determine TAS, TOS and LL-37
study group (passive smoking children)	Diagnostic test: taking saliva samples to determine TAS, TOS and LL-37

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Merve Erkmen Almaz
• Collaborators: Kırıkkale University

Study record dates

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: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• 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