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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06236555
Other study ID # 2023/15, 07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2023
Est. completion date January 15, 2024

Study information

Verified date January 2024
Source Kahramanmaras Sutcu Imam University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to assess the diagnostic potential of gingival crevicular fluid (GCF) biomarkers, specifically 8-iso Prostaglandin F2α (8-iso-PGF2α) and adenosine deaminase (ADA), in evaluating periodontal health and disease conditions.


Description:

Conducted as a single-blind, cross-sectional investigation, this study comprised 26 individuals categorized as periodontally healthy, 27 with gingivitis, and 27 diagnosed with periodontitis. The participant pool included individuals with various periodontal concerns who were referred to the Department of Periodontology Clinic at Kahramanmaraş Sütçü İmam University. The classification of periodontal health, gingivitis, and chronic periodontitis adhered to the 2018 criteria outlined by the European Federation of Periodontology


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date January 15, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients having more than 20 teeth, minimum age 18, maximum age 65 Exclusion Criteria: - Patients with systemic disease, Active smokers, Pregnant women, individuals with a history of orthodontic treatment, or those who had undergone periodontal treatment, regardless of whether it was surgical or non-surgical (within the last one year),

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
8-iso Prostaglandin F2a and Adenosine Deaminase
We took gingival crevicular fluid samples from patients who applied to our clinic and evaluated the -iso Prostaglandin F2a and Adenosine Deaminase levels in the samples.

Locations

Country Name City State
Turkey Kahramanmaras Sütçü Imam University Kahramanmaras Oniki Subat

Sponsors (1)

Lead Sponsor Collaborator
Eda Cetin Ozdemir

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Baltacioglu E, Yuva P, Aydin G, Alver A, Kahraman C, Karabulut E, Akalin FA. Lipid peroxidation levels and total oxidant/antioxidant status in serum and saliva from patients with chronic and aggressive periodontitis. Oxidative stress index: a new biomarker for periodontal disease? J Periodontol. 2014 Oct;85(10):1432-41. doi: 10.1902/jop.2014.130654. Epub 2014 Mar 17. — View Citation

Barros SP, Williams R, Offenbacher S, Morelli T. Gingival crevicular fluid as a source of biomarkers for periodontitis. Periodontol 2000. 2016 Feb;70(1):53-64. doi: 10.1111/prd.12107. — View Citation

Basegmez C, Yalcin S, Yalcin F, Ersanli S, Mijiritsky E. Evaluation of periimplant crevicular fluid prostaglandin E2 and matrix metalloproteinase-8 levels from health to periimplant disease status: a prospective study. Implant Dent. 2012 Aug;21(4):306-10. doi: 10.1097/ID.0b013e3182588408. — View Citation

Basu S. F2-isoprostane induced prostaglandin formation in the rabbit. Free Radic Res. 2006 Mar;40(3):273-7. doi: 10.1080/10715760500511492. — View Citation

Besada P, Mamedova LK, Palaniappan KK, Gao ZG, Joshi BV, Jeong LS, Civan MM, Jacobson KA. NUCLEOSIDE PRODRUGS OF A3 ADENOSINE RECEPTOR AGONISTS AND ANTAGONISTS. Collect Czechoslov Chem Commun. 2006;71(6):912-928. doi: 10.1135/cccc20060912. — View Citation

Koregol AC, Kalburgi NB, Kanniappa Sadasivan S, Warad S, Kamat Wagh A, Thomas T, Sinha P. 8-Isoprostane in chronic periodontitis and type II diabetes: Exploring the link. J Dent Res Dent Clin Dent Prospects. 2018 Fall;12(4):252-257. doi: 10.15171/joddd.2018.039. Epub 2018 Dec 19. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 8-iso Prostaglandin F2a and Adenosine Deaminase scores in periodontal disease We expect 8-iso Prostaglandin F2a and Adenosine Deaminase scores to increase in periodontal disease. 2023
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