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Passive Smoking and LL-37 in Children

Sponsor
Kırıkkale University (Other)
Overall Status
Completed
CT.gov ID
NCT03639376
Collaborator
(none)
180
Enrollment
19
Duration (Months)

Study Details

Study Description

Brief Summary

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)

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    180 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Salivary LL-37 and Periodontal Health in Children Exposed to Passive Smoking
    Study Start Date :
    Nov 1, 2016
    Actual Primary Completion Date :
    Apr 1, 2018
    Actual Study Completion Date :
    Jun 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Antimicrobial Peptide [In the first 18 months of study]

      LL-37 (pg/mL)

    Secondary Outcome Measures

    1. Passive smoking measurement [In the first 18 months of study]

      Cotinine (ng/mL)

    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:

    • Any medications known to affect defense system and periodontium

    • The presence of orthodontic / intraoral appliance

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kırıkkale University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Meltem Karsiyaka Hendek, Assistant Professor, Kırıkkale University
    ClinicalTrials.gov Identifier:
    NCT03639376
    Other Study ID Numbers:
    • 2016/140
    First Posted:
    Aug 21, 2018
    Last Update Posted:
    Aug 21, 2018
    Last Verified:
    Aug 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Meltem Karsiyaka Hendek, Assistant Professor, Kırıkkale University
    Children
    Cotinine
    LL-37
    Passive smoking
    Periodontal health
    Saliva

    Study Results

    No Results Posted as of Aug 21, 2018