Clincosm LogoSign in Get a demo

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

Sponsor
Merve Erkmen Almaz (Other)
Overall Status
Completed
CT.gov ID
NCT04292548
Collaborator
Kırıkkale University (Other)
180
Enrollment
20.9
Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: taking saliva samples to determine TAS, TOS and LL-37

Study Design

Study Type:
Observational
Actual Enrollment :
180 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Actual Study Start Date :
Nov 16, 2016
Actual Primary Completion Date :
Apr 15, 2018
Actual Study Completion Date :
Aug 15, 2018

Arms and Interventions

Arm Intervention/Treatment
study group (passive smoking children)

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

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

Outcome Measures

Primary Outcome Measures

  1. salivary oxidative stress values: TAS level [1 day (once after the dental examination)]

    Unstimulated saliva samples were collected from children.

  2. salivary oxidative stress values: TOS level [1 day (once after the dental examination)]

    Unstimulated saliva samples were collected from children.

  3. salivary LL-37 level [1 day (once after the dental examination)]

    Unstimulated saliva samples were collected from children.

  4. salivary cotinine levels [1 day (once after the dental examination)]

    Unstimulated saliva samples were collected from children for describing passive smoking children.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

-Systemically healthy children

Exclusion Criteria:

  • The presence of orthodontic / intraoral appliance

  • Any disease or condition known to affect defense system

  • Uncooperative children

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Merve Erkmen Almaz
  • Kırıkkale University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Merve Erkmen Almaz, Assist prof, Kırıkkale University
ClinicalTrials.gov Identifier:
NCT04292548
Other Study ID Numbers:
  • Kırıkkale pediatric dentistry
First Posted:
Mar 3, 2020
Last Update Posted:
Mar 3, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dental Caries

Study Results

No Results Posted as of Mar 3, 2020