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

NCT ID: NCT04012983

Last Updated: 2019-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-01

Study Completion Date

2018-09-01

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.

Detailed Description

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Conditions

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Periodontal Disease (Diagnosis) Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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diabetic patients with periodontitis

gingival crevicular fluid level

Intervention Type DIAGNOSTIC_TEST

gingival crevicular fluid collection

periodontitis patients

gingival crevicular fluid level

Intervention Type DIAGNOSTIC_TEST

gingival crevicular fluid collection

healthy control

gingival crevicular fluid level

Intervention Type DIAGNOSTIC_TEST

gingival crevicular fluid collection

Interventions

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gingival crevicular fluid level

gingival crevicular fluid collection

Intervention Type DIAGNOSTIC_TEST

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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Eman Mohamed Amr

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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chemerin and FGF21

Identifier Type: -

Identifier Source: org_study_id

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