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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04012983
Collaborator
(none)
45
1
6
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: gingival crevicular fluid level

Study Design

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
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
Actual Study Start Date :
Mar 1, 2018
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Sep 1, 2018

Arms and Interventions

Arm Intervention/Treatment
diabetic patients with periodontitis

Diagnostic Test: gingival crevicular fluid level
gingival crevicular fluid collection

periodontitis patients

Diagnostic Test: gingival crevicular fluid level
gingival crevicular fluid collection

healthy control

Diagnostic Test: gingival crevicular fluid level
gingival crevicular fluid collection

Outcome Measures

Primary Outcome Measures

  1. 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

  2. measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of periodontitis patients [baseline]

    assessment of GCF FGF21 in patients with periodontitis

  3. measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls [baseline]

    assessment of GCF FGF21 in healthy individuals

Secondary Outcome Measures

  1. 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

  2. measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients [baseline]

    assessment of GCF chemerin in patients with periodontitis

  3. measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls [baseline]

    assessment of GCF chemerin in healthy individuals

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry Cairo Egypt 11431

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eman Mohamed Amr, Associate Professor, Cairo University
ClinicalTrials.gov Identifier:
NCT04012983
Other Study ID Numbers:
  • chemerin and FGF21
First Posted:
Jul 9, 2019
Last Update Posted:
Jul 16, 2019
Last Verified:
Jul 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 16, 2019