Diabetes Mellitus, Type 2, Periodontal Disease (Diagnosis)
Conditions
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.
Interventions
DIAGNOSTIC_TESTgingival crevicular fluid level
gingival crevicular fluid collection
Sponsors
Cairo University
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of healthy controls | baseline | assessment of GCF FGF21 in healthy individuals |
| 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 |
| measurement of the level of FGF21 (pg/ml) in gingival crevicular fluid of periodontitis patients | baseline | assessment of GCF FGF21 in patients with periodontitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of periodontitis patients | baseline | assessment of GCF chemerin in patients with periodontitis |
| measurement of the level of chemerin (ng/ml) in gingival crevicular fluid of healthy controls | baseline | assessment of GCF chemerin in healthy individuals |
Countries
Egypt
Outcome results
None listed