Periodontal DiseasesNCT06236555
Exploring 8-iso Prostaglandin F2α and Adenosine Deaminase Levels in Periodontal Health and Disease
A study testing 8-iso Prostaglandin F2α and Adenosine Deaminase in people with Periodontal Diseases, run by Eda Cetin Ozdemir at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- 8-iso Prostaglandin F2α and Adenosine Deaminase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients having more than 20 teeth, minimum age 18, maximum age 65
Who cannot join
- 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),
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kahramanmaraş Sütçü İmam University
Kahramanmaraş, Oniki Şubat, 46060
About this study
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.
Read the 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
- Conditions
- Periodontal Diseases
- Being tested
- 8-iso Prostaglandin F2α and Adenosine Deaminase
- Keywords
- 8-isoprostane, adenosine deaminase, GCF
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-iso Prostaglandin F2α and Adenosine DeaminaseDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Kahramanmaraş Sütçü İmam University | Other | Patients who apply to our clinic for routine periodontal treatment will be included in the study. Receives: Diagnostic Test: 8-iso Prostaglandin F2α and Adenosine Deaminase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 8-iso Prostaglandin F2α and Adenosine Deaminase scores in periodontal disease
We expect 8-iso Prostaglandin F2α and Adenosine Deaminase scores to increase in periodontal disease.
Measured: 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Oct 2023
- Primary completion31 Dec 2023
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eda Cetin Ozdemir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Eda Cetin Ozdemir, Kahramanmaras Sutcu Imam University
- Investigators
- Eda Çetin Özdemir, Dr, Principal investigator, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06236555
- Sponsor's protocol ID
- 2023/15, 07
- Status last verified
- Jan 2024
- First submitted
- 24 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24635543Barros 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.
PubMed 26662482Basegmez 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.
PubMed 22814555Basu S. F2-isoprostane induced prostaglandin formation in the rabbit. Free Radic Res. 2006 Mar;40(3):273-7. doi: 10.1080/10715760500511492.
PubMed 16484043Besada 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.
PubMed 34815583Koregol 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.
PubMed 30774790
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring 8-iso Prostaglandin F2α and Adenosine Deaminase Levels in Periodontal Health and Disease
- ClinicalTrials.gov ID
- NCT06236555
- Acronym / sponsor ID
- 2023/15, 07
- Conditions
- Periodontal Diseases
- Keywords
- 8-isoprostane, adenosine deaminase, GCF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eda Cetin OzdemirUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 1 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kahramanmaraş Sütçü İmam University | Other | Diagnostic Test: 8-iso Prostaglandin F2α and Adenosine DeaminasePatients who apply to our clinic for routine periodontal treatment will be included in the study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients having more than 20 teeth, minimum age 18, maximum age 65
Key exclusion criteria (1 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-iso Prostaglandin F2α and Adenosine DeaminaseWe 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. | Diagnostic test | Kahramanmaraş Sütçü İmam University |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Background: PubMed 24635543Baltacioglu 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.
- Background: PubMed 26662482Barros 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.
- Background: PubMed 22814555Basegmez 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.
- Background: PubMed 16484043Basu S. F2-isoprostane induced prostaglandin formation in the rabbit. Free Radic Res. 2006 Mar;40(3):273-7. doi: 10.1080/10715760500511492.
- Background: PubMed 34815583Besada 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.
- Background: PubMed 30774790Koregol 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eda Çetin Özdemir, Dr principal investigator
Kahramanmaras Sutcu Imam University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-iso Prostaglandin F2α and Adenosine Deaminase in people with Periodontal Diseases, run by Eda Cetin Ozdemir at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 8-iso Prostaglandin F2α and Adenosine Deaminase scores in periodontal disease (time frame: 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06236555, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.