NCT06236555

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 1, 2024

Completed
Last Updated

February 1, 2024

Status Verified

January 1, 2024

Enrollment Period

3 months

First QC Date

January 24, 2024

Last Update Submit

January 24, 2024

Conditions

Periodontal Diseases

Keywords

8-isoprostane, adenosine deaminase, GCF

Outcome Measures

Primary Outcomes (1)

  • 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.

    2023

Study Arms (1)

Kahramanmaraş Sütçü İmam University

OTHER

Patients who apply to our clinic for routine periodontal treatment will be included in the study.

Diagnostic Test: 8-iso Prostaglandin F2α and Adenosine Deaminase

Interventions

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.

Kahramanmaraş Sütçü İmam University

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients having more than 20 teeth, minimum age 18, maximum age 65

You may not qualify if:

  • 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),

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kahramanmaraş Sütçü İmam University

Kahramanmaraş, Oniki Şubat, 46060, Turkey (Türkiye)

Location

Related 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.

    PMID: 24635543BACKGROUND

  • 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.

    PMID: 26662482BACKGROUND

  • 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.

    PMID: 22814555BACKGROUND

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

    PMID: 16484043BACKGROUND

  • 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.

    PMID: 34815583BACKGROUND

  • 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.

    PMID: 30774790BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Study Officials

  • Eda Çetin Özdemir, Dr

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

January 24, 2024

First Posted

February 1, 2024

Study Start

October 1, 2023

Primary Completion

December 31, 2023

Study Completion

January 15, 2024

Last Updated

February 1, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)