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OpenTrials
Completed

NCT Number: NCT03631498

Apoptotic Changes in Gingiva Caused by Smoking

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.

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Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaziosmanpasa University Faculty of Dentistry

Tokat Province, 60100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Fibroblast and total inflammatory cell counts

    Time frame: 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 outcomes

  1. Apoptotic markers

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

Apoptosis and Tissue Destruction in Gingival Tissues of Smoker and Non-smoker Periodontitis Patients

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2018
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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