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

Completed

• Conditions: Diabetes Mellitus, Type 2; Periodontal Disease (Diagnosis)
• Interventions: Diagnostic Test: gingival crevicular fluid level

• Registration Number: NCT04012983
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-08-01
• Study Completion: 2018-09-01
• Status Verified: 2019-07
• Study First Submitted: 2019-07-03
• Study First Submitted QC: 2019-07-05
• Study First Posted: 2019-07-09
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
diabetic patients with periodontitis	gingival crevicular fluid level	-
periodontitis patients	gingival crevicular fluid level	-
healthy control	gingival crevicular fluid level	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt