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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03631498
Other study ID # Ozkan
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2017
Est. completion date April 10, 2018

Study information

Verified date August 2018
Source Tokat Gaziosmanpasa University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date April 10, 2018
Est. primary completion date January 10, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 50 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Gaziosmanpasa University Faculty of Dentistry Tokat

Sponsors (1)

Lead Sponsor Collaborator
Tokat Gaziosmanpasa University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fibroblast and total inflammatory cell counts Fibroblast and total inflammatory cell counts in the groups were determined in a standardized 1000 micrometer square area with histomorphometric evaluation. Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after.
Secondary Apoptotic markers Apoptotic and anti-apoptotic proteins and enzymes related to apoptosis were evaluated via immunohistochemistry. Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
Secondary Hypoxia and tissue destruction markers Vascular endothelial growth factor and hypoxia-inducible factor as hypoxia markers and matrix metalloproteinase and it inhibitor as destruction markers were evaluated via immunohistochemistry. Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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