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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Periodontal Disease (Diagnosis), Diabetes Mellitus, Type 2

Intervention / Treatment
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* Diagnostic Test: gingival crevicular fluid level


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| diabetic patients with periodontitis<br> | Diagnostic Test: gingival crevicular fluid level<br>* gingival crevicular fluid collection<br>|
| periodontitis patients<br> | Diagnostic Test: gingival crevicular fluid level<br>* gingival crevicular fluid collection<br>|
| healthy control<br> | Diagnostic Test: gingival crevicular fluid level<br>* gingival crevicular fluid collection<br>|

What is the study measuring?
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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 |