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

The current study aims to spot the light on the possible role of gingival crevicular fluid (GCF) level of Chemerin and FGF21 to study their potential role as biomarkers of periodontal disease and to understand their role in the link between periodontitis and diabetes .

The study will be conducted on three groups; group (A) include fifteen controlled T2 DM patients suffering from periodontitis, group (B) include fifteen patients suffering from periodontitis alone, and group C) include fifteen periodontally and medically healthy individuals. GCF samples will be collected from all participants for assessment of Chemerin and FGF 21. Samples will be analysed using ELISA technique.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Periodontal Disease (Diagnosis)
• Intervention / Treatment: Diagnostic test: gingival crevicular fluid level

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11431
    • Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

forty five individuals (ranging in age from 35-60 years) recruited from the outpatient clinic of Oral Medicine, and Periodontology Department, Faculty of Dentistry, Cairo University

The participants were divided into the following three groups:

Group (1): 15 patients with periodontitis and controlled t2DM and no other systemic disease.

Group (2): 15 systemically healthy individuals having periodontitis. Group (3): 15 periodontally and systemically healthy individuals.

Description

Inclusion Criteria:

• 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

Exclusion criteria

• 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.
• Smoking over the past 5 years.
• Periapical pathologies.
• Exposure to mechanical forces as a result of occlusion/ orthodontics.
• History of periodontal or drug therapies within the previous 6 months.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
healthy control	Diagnostic test: gingival crevicular fluid level; gingival crevicular fluid collection
diabetic patients with periodontitis	Diagnostic test: gingival crevicular fluid level; gingival crevicular fluid collection
periodontitis patients	Diagnostic test: gingival crevicular fluid level; gingival crevicular fluid collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of diabetic patients with periodontitis	assessment of GCF FGF21 in diabetic patients with periodontitis	baseline
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of periodontitis patients	assessment of GCF FGF21 in patients with periodontitis	baseline
measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls	assessment of GCF FGF21 in healthy individuals	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of diabetic patients with periodontitis	assessment of GCF chemerin in diabetic patients with periodontitis	baseline
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients	assessment of GCF chemerin in patients with periodontitis	baseline
measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls	assessment of GCF chemerin in healthy individuals	baseline

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: July 3, 2019
• First Submitted That Met QC Criteria: July 5, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 16, 2019
• Last Update Submitted That Met QC Criteria: July 12, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Stomatognathic Diseases; Mouth Diseases; Diabetes Mellitus, Type 2; Periodontal Diseases
• Other Study ID Numbers: chemerin and FGF21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No