- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06236555
Exploring 8-iso Prostaglandin F2α and Adenosine Deaminase Levels in Periodontal Health and Disease
January 24, 2024 updated by: Eda Cetin Ozdemir
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oniki Şubat
-
Kahramanmaraş, Oniki Şubat, Turkey, 46060
- Kahramanmaras Sutcu Imam University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Kahramanmaraş Sütçü İmam University
Patients who apply to our clinic for routine periodontal treatment will be included in the study.
|
We took gingival crevicular fluid samples from patients who applied to our clinic and evaluated the -iso Prostaglandin F2α and Adenosine Deaminase levels in the samples.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 8-iso Prostaglandin F2α and Adenosine Deaminase scores in periodontal disease
Time Frame: 2023
|
We expect 8-iso Prostaglandin F2α and Adenosine Deaminase scores to increase in periodontal disease.
|
2023
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eda Çetin Özdemir, Dr, Kahramanmaras Sutcu Imam University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- Basu S. F2-isoprostane induced prostaglandin formation in the rabbit. Free Radic Res. 2006 Mar;40(3):273-7. doi: 10.1080/10715760500511492.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2023
Primary Completion (Actual)
December 31, 2023
Study Completion (Actual)
January 15, 2024
Study Registration Dates
First Submitted
January 24, 2024
First Submitted That Met QC Criteria
January 24, 2024
First Posted (Estimated)
February 1, 2024
Study Record Updates
Last Update Posted (Estimated)
February 1, 2024
Last Update Submitted That Met QC Criteria
January 24, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Stomatognathic Diseases
- Mouth Diseases
- Periodontal Diseases
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Vasodilator Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Purinergic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Oxytocics
- Purinergic P1 Receptor Agonists
- Purinergic Agonists
- Adenosine
- Dinoprost
- Dinoprost tromethamine
Other Study ID Numbers
- 2023/15, 07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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