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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04115176
Other study ID # PYO.DIS.1901.17.002
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2017
Est. completion date July 10, 2019

Study information

Verified date October 2019
Source Ondokuz Mayis University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study was performed to evaluate the effects of both periodontal treatment and smoking on the gingival crevicular fluid(GCF) levels of interleukin (IL)-17A, IL-17E, Total oxidative stress(TOS) and total antioxidant capasity(TAOC) in smoking and non-smoking patients with severe chronic periodontitis.

Systemically healthy 15 smoker,15 non-smoker with chronic periodontitis were attended for the study. Periodontal status were determined by recording periodontal clinical measurements. GCF samples were collected at the baseline, at the end of initial periodontal treatment and 4 weeks after periodontal flap surgery. The data were tested statistically by the Student t and paired sample t tests.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date July 10, 2019
Est. primary completion date July 10, 2019
Accepts healthy volunteers No
Gender All
Age group 35 Years to 60 Years
Eligibility Inclusion Criteria:

- individuals aged ?35 years and having =16 teeth diagnosed as chronic periodontitis

- not received any periodontal therapy within the previous 6 months;

- not received antibiotic/anti-inflammatory drug treatment within the previous 6 months.

Exclusion Criteria:

- receiving medical treatment for cancer, rheumatoid arthritis, diabetes mellitus, cardiovascular disease, or any other systemic disease;

- being pregnant or being in the period of menopause or lactation;

- receiving any drug therapy that might affect the clinical characteristics of periodontitis;

- usage of systemic antimicrobials during the 6 weeks prior to data collection

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey Müge Lütfioglu Samsun Atakum

Sponsors (1)

Lead Sponsor Collaborator
Ondokuz Mayis University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary GCF IL-17A VOLUME IL-17A is a cytokine present in gingival crevicular fluid. Its volume calculated as microliter and changes due to inflammation caused by periodontal disease. GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
Primary GCF IL-17E VOLUME IL-17E is a cytokine present in gingival crevicular fluid. Its volume calculated as microliter and changes due to inflammation caused by periodontal disease. GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
Primary GCF TOTAL OXIDATIVE STRESS (TOS) LEVEL TOS is the measurement of oxidative stress amount and given as mmol/L unit. Its amount changes due to inflammation caused by periodontal disease. GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
Primary GCF TOTAL ANTIOXIDANT CAPASITY (TAOC) TAOC is the antioxidant amount measured and given as µmol H2O2 Eq/L unit. Its amount changes due to inflammation caused by periodontal disease. GCF sampling was performed prior to periodontal treatment , 4 weeks after completion of initial periodontal treatment, and 4 weeks after periodontal flap surgery .
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