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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03625414
Other study ID # balciyuce
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 1, 2017
Est. completion date June 1, 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

Present study intended to compare diseased and healthy sites in chronic and aggressive periodontitis with healthy individuals. The investigators suggest that even unaffected healthy sites of both chronic and aggressive periodontitis patients exhibit subclinical inflammation and tissue destruction with decreased fibroblast cell counts and increased inflammatory cell counts. Investigators also suggest that a possible mechanism which might play a role in the disease progression might occur via a disbalance between matrix metalloproteinases and their inhibitors, and increased hypoxia in diseased sites.


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, there are many dark points in the etiopathogenesis of aggressive periodontitis. The existence of periodontal destruction at even one tooth in the mouth increases the risk of further periodontal destruction. However, the incidence of progression of the disease to the unaffected teeth was not demonstrated. Yet, the progression of the disease from diseased sites to healthy sites is likely to occur but no evidence is present comparing healthy and diseased sites of chronic and aggressive periodontitis. Present study aimed to evaluate the histological changes in both diseased and healthy sites in both localized aggressive periodontitis (LAgP) and chronic periodontitis (CP) patients by determining fibroblast and inflammatory cell counts in histologic slides and immunohistochemical staining of enzymes and hypoxia markers in order to better understand the dimensions of this demolition in periodontal disease.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date June 1, 2018
Est. primary completion date February 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 45 Years
Eligibility Inclusion Criteria:

Age range from 30 to 45, the existence of at least 20 functioning teeth, no history of smoking, systemical health, no antibiotic use within 6 months, no periodontal therapy within 6 months, no pregnancy or lactation, no drug use, in addition; For healthy individuals, the existence of oral health

- For localized aggressive periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.

- For chronic periodontitis, the existence of the disease at least for 5 years, the presence of both healthy and diseased sites in the same patient.

Exclusion Criteria:

- Patients younger than 30 older than 45 years old, the absence of occlusion, drug use, pregnancy/lactation, smoking, 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 Immunohistochemical staining Expressions of matrix metalloproteinase 8 and tissue inhibitor, hypoxia inducible factor-1alpha and vascular endothelial growth factor were evaluated in histological slides. Biopsies were obtained a day after initial examinations, histological analysis were performed 2 weeks after
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