Diabetes Mellitus Clinical Trial
Official title:
Association of Gingival Crevicular Fluid Chemerin and IL-6 Levels in Chronic Periodontitis With and Without Type 2 Diabetes Mellitus After Non-Surgical Periodontal Therapy
The aims of the present study were to determine the gingival crevicular fluid (GCF) chemerin and interleukin-6 (IL-6) levels and to analyse the relationship between chemerin and IL-6 in periodontal health and in chronic periodontitis (CP) with and without type 2 diabetes mellitus (T2DM) as well as to evaluate the effect of non-surgical periodontal therapy on the GCF chemerin levels.
Adipose tissue is an active endocrine organ that secretes several inflammatory cytokines,
namely, adipokines, which interfere with insulin sensitivity, with glucose and lipid
metabolism, and with the inflammatory process.Chemerin, a more recently identified adipose
tissue specific adipokine, has a crucial role in adipocyte differentiation and development,
as well as in glucose, lipid metabolism and inflammation. Experimental data supports both
pro- and anti-inflammatory roles for chemerin in immune cells. Therefore, it is not clear
whether chemerin contributes more to the progression of inflammation or the resolution.The
present investigation has been devoted to elucidate the role of chemerin in the pathogenesis
that might link between DM and periodontal disease. We hypothesize that chemerin may hold
value as an inflammatory mediator in CP patients with and without T2DM and non-surgical
periodontal treatment could have a beneficial influence on the levels of chemerin.
The aim of this study were:
1. to determine the role of chemerin in the pathogenesis of periodontal disease and DM via
comparing with GCF levels of IL-6, which has a known proinflammatory effect in
periodontal disease and DM
2. to evaluate the effect of non-surgical periodontal treatment on GCF chemerin levels in
periodontitis patients with and without T2DM.
The study included eighty subjects: 20 subjects with systemically and periodontally healthy
(CTRL group), 20 patients with T2DM and periodontally healthy (DM-CTRL group), 20 patients
with systemically healthy and CP (CP group), 20 patients with CP and T2DM (DM-CP group).
Periodontitis patients received nonsurgical periodontal therapy. GCF sampling and clinical
periodontal parameters were assessed at baseline and 6 weeks after periodontal therapy.
Chemerin and interleukin-6 (IL-6) levels were measured by enzyme-linked immunosorbent assay,
and their relative ratios were calculated.
Subjects were clinically evaluated using the following parameters; plaque index (PI),
gingival index (GI) , PD, clinical attachment level (CAL) and BOP (deemed positive if it
occurred within 15 seconds after probing). Clinical measurements were recorded by one
calibrated examiner at six sites per tooth from the full-mouth teeth excluding third molars
using with a Williams periodontal probe (Nordent Manufacturing Inc., ElkGrove Village, IL,
USA) calibrated in millimeters. Anthropometric measurements included weight (kg) and height
(m) of the subjects to calculate the BMI ( weight divided by the square of height, kg/m2 ).
All clinical and radiological examinations, sampling site selections were performed by one
examiner and the samples were collected on the day after clinical examination of patients.
This was to prevent contamination of GCF with blood associated with the probing of inflamed
sites. The deepest two pocket sites of single-rooted teeth were selected for the collection
of GCF in both periodontitis groups, and also two pocket sites with an absence of
inflammation were sampled to ensure the collection of an adequate amount of GCF in control
groups. In patients from CP and DM-CP groups, sites showing greatest PD when measured with a
periodontal probes and signs of inflammation, along with radiographic conformation of bone
loss were sampled. GCF samples were collected at baseline and after 8 weeks from baseline
sampling in both periodontitis groups, and only at baseline in control groups. To avoid
salivary contamination, the sites to be sampled were rinsed with water, isolated by cotton
rolls and gently air dried. Paper strips (Periopaper; Oraflow Inc.,Smithtown, NY, USA) were
gently inserted 1-2 mm into the sulcus/pocket for 30 seconds. Care was taken to avoid
mechanical injury of the gingival tissues. All samples containing blood and saliva were
discarded. The two strips from two sites of each individual were placed into coded sealed
plastic eppendorf tubes and pooled before freezing at -80 degree
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03743779 -
Mastering Diabetes Pilot Study
|
||
Completed |
NCT03786978 -
Pharmaceutical Care in the Reduction of Readmission Rates in Diabetes Melitus
|
N/A | |
Completed |
NCT01804803 -
DIgital Assisted MONitoring for DiabeteS - I
|
N/A | |
Completed |
NCT05039970 -
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04068272 -
Safety of Bosentan in Type II Diabetic Patients
|
Phase 1 | |
Completed |
NCT03243383 -
Readmission Prevention Pilot Trial in Diabetes Patients
|
N/A | |
Completed |
NCT03730480 -
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
|
N/A | |
Recruiting |
NCT02690467 -
Efficacy, Safety and Acceptability of the New Pen Needle 34gx3,5mm.
|
N/A | |
Completed |
NCT02229383 -
Phase III Study to Evaluate Safety and Efficacy of Added Exenatide Versus Placebo to Titrated Basal Insulin Glargine in Inadequately Controlled Patients With Type II Diabetes Mellitus
|
Phase 3 | |
Completed |
NCT05799976 -
Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure
|
N/A | |
Completed |
NCT06181721 -
Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes
|
N/A | |
Recruiting |
NCT04489043 -
Exercise, Prediabetes and Diabetes After Renal Transplantation.
|
N/A | |
Withdrawn |
NCT03319784 -
Analysis for NSAID VS Corticosteroid Shoulder Injection in Diabetic Patients
|
Phase 4 | |
Completed |
NCT03542084 -
Endocrinology Auto-Triggered e-Consults
|
N/A | |
Completed |
NCT02229396 -
Phase 3 28-Week Study With 24-Week and 52-week Extension Phases to Evaluate Efficacy and Safety of Exenatide Once Weekly and Dapagliflozin Versus Exenatide and Dapagliflozin Matching Placebo
|
Phase 3 | |
Recruiting |
NCT05544266 -
Rare and Atypical Diabetes Network
|
||
Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
Completed |
NCT05031000 -
Blood Glucose Monitoring Systems: Discounter Versus Brand
|
N/A | |
Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A |