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

NCT04012983 | Completed

• 1 other identifier: chemerin and FGF21
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal Disease (Diagnosis); Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of diabetic patients with periodontitis

  baseline

• measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients

  baseline

• measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls

  baseline

Study Arms (3)

diabetic patients with periodontitis

Diagnostic Test: gingival crevicular fluid level

periodontitis patients

Diagnostic Test: gingival crevicular fluid level

healthy control

Diagnostic Test: gingival crevicular fluid level

Interventions

gingival crevicular fluid level DIAGNOSTIC_TEST

gingival crevicular fluid collection

diabetic patients with periodontitis; healthy control; periodontitis patients

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry

Cairo, 11431, Egypt

Location

MeSH Terms

Conditions

Periodontal Diseases; Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 3, 2019
• First Posted: July 9, 2019
• Study Start: March 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 16, 2019

Record last verified: 2019-07

Locations

EG (1)