Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Disease (Diagnosis)
Diabetes Mellitus, Type 2
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-07-09
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of diabetic patients with periodontitis
timeFrame: baseline
measure: measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of periodontitis patients
timeFrame: baseline
measure: measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls
timeFrame: baseline
Secondary outcomes:
measure: measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of diabetic patients with periodontitis
timeFrame: baseline
measure: measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients
timeFrame: baseline
measure: measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls
timeFrame: baseline
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References: