Passive Smoking and LL-37 in Children

August 20, 2018 updated by: Meltem Karsiyaka Hendek, Kırıkkale University

Salivary LL-37 and Periodontal Health in Children Exposed to Passive Smoking

This study investigates the salivary LL-37 in passive smoking-exposed and unexposed children and the association between salivary LL-37 levels and periodontal clinical parameters in these children.Unstimulated salivary samples were collected from 180 children (90 passive smoking-exposed and 90 passive smoking-unexposed)

Study Overview

Status

Completed

Conditions

Detailed Description

Diverse mechanisms conduce to the detrimental periodontal effects of passive smoking, including alteration of both microbial and host response factors.

Antimicrobial peptides are considered to be an important intermediate step in initiating an initial immune response against the microbial side of the oral gingival epithelium and in the transition to acquired immunity.

LL-37 has a wide antimicrobial activity against both cariogenic and periopathogenic bacteria and its role in maintaining oral health has recently been stated

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

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children were selected from patients referred to Kirikkale University, Faculty of Dentistry, and Department of Pediatric Dentistry

Description

Inclusion Criteria:

  • Systemically healthy children

Exclusion Criteria:

  • Any medications known to affect defense system and periodontium
  • The presence of orthodontic / intraoral appliance

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

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Passive smoking-exposed children
This group consists of children whose family members have smoked at home since the birth of the child.
Passive smoking-unexposed children
This group consists of children whose family members have not smoked at home since the birth of the child.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antimicrobial Peptide
Time Frame: In the first 18 months of study
LL-37 (pg/mL)
In the first 18 months of study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Passive smoking measurement
Time Frame: In the first 18 months of study
Cotinine (ng/mL)
In the first 18 months of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kırıkkale University

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

November 1, 2016

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

August 16, 2018

First Submitted That Met QC Criteria

August 20, 2018

First Posted (Actual)

August 21, 2018

Study Record Updates

Last Update Posted (Actual)

August 21, 2018

Last Update Submitted That Met QC Criteria

August 20, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

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.

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