Completed

Gingival Crevicular Fluid Chemerin and Fibroblast Growth Factor 21 as Periodontal Disease Biomarkers in Diabetic and Non-diabetic Patients

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Study Aim

This study aims to observe and compare the levels of Fibroblast Growth Factor 21 in the gingival crevicular fluid of diabetic patients with periodontitis, non-diabetic patients with periodontitis, and healthy individuals.

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Diabetes Mellitus+9

+ Diabetes Mellitus, Type 2

+ Disease

From 35 to 60 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: March 2018
See protocol details

Summary

Principal SponsorCairo University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2018

Actual date on which the first participant was enrolled.

This study focuses on understanding the potential role of two substances, Chemerin and Fibroblast Growth Factor 21 (FGF21), found in gingival crevicular fluid (GCF), a fluid present in the gums. The goal is to determine if these substances can serve as markers for periodontal disease, a common gum condition, and to explore their role in the connection between periodontitis and diabetes. The study involves three groups: diabetic patients with periodontitis, patients with only periodontitis, and healthy individuals without periodontitis or any other medical conditions. During the study, GCF samples are collected from all participants to measure the levels of Chemerin and FGF21. These samples are then analyzed using a technique called ELISA. The primary outcomes of the study include measuring the levels of FGF21 in the GCF of diabetic patients with periodontitis, in patients with only periodontitis, and in healthy individuals. This observational study aims to provide valuable insights into the potential use of these substances as biomarkers for periodontal disease and their association with diabetes.

Official TitlePossible Role of Gingival Crevicular Fluid Levels of Chemerin and Fibroblast Growth Factor 21 as Biomarkers of Periodontal Disease in Diabetic and Non-diabetic Patients
NCT04012983
Principal SponsorCairo University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 35 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2DiseaseEndocrine System DiseasesMetabolic DiseasesStomatognathic DiseasesMouth DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPeriodontal DiseasesPathological Conditions, Signs and SymptomsGlucose Metabolism Disorders

Criteria

4 inclusion criteria required to participate
age range between 35 and 60 years
a minimum of 20 natural teeth.
Type 2DM patients exhibiting HbA1c 6-8% and FPG ≥126 mg/dL for more than one year who did not complain of any systemic diseases other than t2DM
periodontitis patients with moderate to severe periodontitis having gingival index GI ≥ 1, probing depth PD ≥ 5, and clinical attachment level CAL ≥ 4 mm, and bone loss affecting > 30% of existing teeth on clinical/radiographic examination
8 exclusion criteria prevent from participating
uncontrolled diabetes mellitus
systemic diseases which may affect the biomarkers levels and the periodontal conditions.
Exposure to steroid therapies, radiation/immune-suppressive therapies.
Allergic reaction to any kind of drug.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Faculty of Dentistry

Cairo, EgyptOpen Faculty of Dentistry in Google Maps
CompletedOne Study Center
Gingival Crevicular Fluid Chemerin and Fibroblast Growth Factor 21 as Periodontal Disease Biomarkers in Diabetic and Non-diabetic Patients | PatLynk