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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012983
• Other study ID #: chemerin and FGF21
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: September 1, 2018

Study information

• Verified date: July 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Periodontal Disease (Diagnosis)
• Periodontal Diseases

Intervention

Diagnostic Test:
• gingival crevicular fluid level
gingival crevicular fluid collection

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of periodontitis patients	assessment of GCF FGF21 in patients with periodontitis	baseline
Primary	measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls	assessment of GCF FGF21 in healthy individuals	baseline
Secondary	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
Secondary	measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients	assessment of GCF chemerin in patients with periodontitis	baseline
Secondary	measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls	assessment of GCF chemerin in healthy individuals	baseline