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Completed

NCT Number: NCT04012983

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

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.

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Key information

Conditions

Periodontal Disease (Diagnosis) Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Periodontal Diseases Stomatognathic Diseases

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry

Cairo, 11431, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gingival crevicular fluid level

Diagnostic Test

gingival crevicular fluid collection

Primary outcomes

  1. measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of diabetic patients with periodontitis

    Time frame: 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

    Time frame: 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

    Time frame: baseline

    assessment of GCF FGF21 in healthy individuals

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: baseline

    assessment of GCF chemerin in healthy individuals

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jul 9, 2019
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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