Clincosm LogoSign in Get a demo

Apoptotic Changes in Gingiva Caused by Smoking

Sponsor
Tokat Gaziosmanpasa University (Other)
Overall Status
Completed
CT.gov ID
NCT03631498
Collaborator
(none)
60
Enrollment
1
Location
14.9
Actual Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Smoking is a major environmental risk factor associated with common forms of human chronic periodontitis. The aim of the present study was to evaluate apoptotic tissue alterations and tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy individuals. The investigators of the study suggest that smoking decrease tissue quality and increase inflammation level in gingival tissues in both healthy individuals and periodontitis patients. One possible mechanism for this is suggested to be increased apoptosis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. The etiology and pathogenesis of chronic periodontitis are mostly revealed, however, the mechanism of environmental factors such as smoking yet to be clarified. Major consequences of smoking in gingival tissues are suggested to be the reduction in neutrophil and fibroblast function, decreased immunoglobulin G production, increased periodontal pathogen bacteria prevalence, difficulty in eliminating pathogens with mechanical therapy, and reduction in growth factor production. In the present study, markers of tissue destruction, matrix metalloproteinase-8 and tissue inhibitor of matrix metalloproteinase-1, hypoxia markers, vascular endothelial growth factor and hypoxia-inducible factor and apoptotic markers, bax, bcl-2, and caspase-3 were evaluated.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Apoptosis and Tissue Destruction in Gingival Tissues of Smoker and Non-smoker Periodontitis Patients
    Actual Study Start Date :
    Jan 10, 2017
    Actual Primary Completion Date :
    Jan 10, 2018
    Actual Study Completion Date :
    Apr 10, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Healthy individuals

    Gingival biopsies of healthy individuals who were never-smokers and had no systemic or oral disease or condition.
    periodontitis patients

    Gingival biopsies of periodontitis patients who were never-smokers and had no systemic disease or condition.
    Healthy smokers

    Gingival biopsies of healthy individuals who were smokers but no systemic or oral disease or condition.
    Smokers with periodontitis

    Gingival biopsies of periodontitis patients who were smokers but no systemic disease or condition.

    Outcome Measures

    Primary Outcome Measures

    1. Fibroblast and total inflammatory cell counts [Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.]

      Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation.

    Secondary Outcome Measures

    1. Apoptotic markers [Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after]

      Apoptotic and anti-apoptotic proteins and enzymes related to apoptosis were evaluated via immunohistochemistry.

    2. Hypoxia and tissue destruction markers [Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after]

      Vascular endothelial growth factor and hypoxia-inducible factor as hypoxia markers and matrix metalloproteinase and it inhibitor as destruction markers were evaluated via immunohistochemistry.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age range from 30 to 45,

    • the existence of at least 20 functioning teeth,

    • systemical health,

    • no antibiotic use within 6 months,

    • no periodontal therapy within 6 months,

    • no pregnancy or lactation,

    • no drug use, in addition; for the smokers existence of the smoking condition for at least five years.

    Exclusion Criteria:

    • Patients younger than 30 older than 50 years old,

    • the absence of occlusion,

    • drug use,

    • pregnancy/lactation,

    • previous antibiotic use,

    • previous periodontal therapy,

    • the existence of any systemical disease.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gaziosmanpasa University Faculty of Dentistry Tokat Turkey 60100

    Sponsors and Collaborators

    • Tokat Gaziosmanpasa University

    Investigators

    • Principal Investigator: HATİCE BALCI YÜCE, PhD, Gaziosmanpasa University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hatice Balci Yuce, Principal investigator, Tokat Gaziosmanpasa University
    ClinicalTrials.gov Identifier:
    NCT03631498
    Other Study ID Numbers:
    • Ozkan
    First Posted:
    Aug 15, 2018
    Last Update Posted:
    Aug 16, 2018
    Last Verified:
    Aug 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hatice Balci Yuce, Principal investigator, Tokat Gaziosmanpasa University
    smoking
    hypoxia
    apoptosis
    chronic periodontitis
    Additional relevant MeSH terms:
    Periodontitis
    Chronic Periodontitis

    Study Results

    No Results Posted as of Aug 16, 2018