Condition 1: Type 2 diabetes. Condition 2: Periodontitis. Type 2 diabetes mellitus
Conditions
Interventions
Intervention group: Group 1: Patients with Diabetes (10), Group 2: Patients with periodontitis (10), Group 3: Patients with Diabetes with periodontitis (10), and Group 4: Healthy controls (10). - Prob
Sponsors
Hamedan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
20 Years to 60 Years
Inclusion criteria
Inclusion criteria: Diabetic Group: According to the criteria of the American Diabetes Association (38), individuals meeting any of the following criteria are considered to have T2DM: fasting plasma glucose (FPG) = 126 mg/dL, and hemoglobin A1C = 6.5%. Patients with controlled diabetes (= 7.5%) who have been diagnosed for at least one year and use only oral anti-diabetic drugs (OAD) for blood sugar control will be included in the study. Periodontitis Group: A comprehensive periodontal examination will be conducted by a periodontist at the dental clinic. During the periodontal examination, the plaque index (PI), gingival index (GI), periodontal pocket depth (PPD), and clinical attachment loss (CAL) will be assessed. Patients with untreated moderate to severe chronic periodontitis (at least one tooth in each quadrant with bleeding on probing, pocket depth = 5 mm, and attachment loss = 4 mm) will be included in the study (39). Healthy Control Group: Healthy individuals without acute or chronic diseases, malignancies, immunodeficiency, hypertension, metabolic diseases, or oral diseases based on diagnostic criteria for diabetes and periodontitis.
Exclusion criteria
Exclusion criteria: Pregnant and breastfeeding women Individuals using insulin Individuals with chronic cardiovascular, renal, hepatic, pulmonary diseases, chronic or acute inflammatory diseases, cancer, and psychiatric disorders Individuals with short bowel syndrome and allergies Diabetic patients with microvascular and macrovascular complications Individuals with untreated oral abscesses Use of medications that alter saliva secretion Individuals with fixed orthodontic appliances Use of antibiotics or probiotics within three months prior to entering the study Consumption of foods containing probiotics Individuals who are addicted, alcoholics, smokers, and tobacco users
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gut microbiota. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Quantitative real-time_ Polymerase Change Reaction.;Saliva microbiota. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Quantitative real-time_ Polymerase Change Reaction.;Short-chain fatty acids. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Gas chromatography. | — |
Secondary
| Measure | Time frame |
|---|---|
| High-Sensitivity C-Reactive Protein. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Enzyme-Linked Immunosorbent Assay.;Insulin resistance. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Homeostasis Model Assessment- Insulin Resistance.;Superoxide dismutase. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Fluorimetry.;Total antioxidant capacity. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Ferric Reducing Antioxidant Power.;Total oxidant status. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: Fluorimetry.;Serum insulin. Timepoint: ??? ?? ???? ?????? ? ?? ???? ?? ?? ???? ??????. Method of measurement: Enzyme-Linked Immunosorbent Assay.;Fasting blood sugar. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: The enzymatic colorimetric method.;Serum triglycerides. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: The enzymatic colorimetric method.;High-Density Lipoprotein cholesterol. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: The enzymatic colorimetric method.;Low-density lipoprotein cholesterol. Timepoint: Before the start of the intervention and 12 weeks after the start of the intervention. Method of measurement: The enzymatic colorimetric method.;Serum Cholesterol. Timepoint: Before the start of the intervention and 12 weeks after the | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Yousef Alikhani
Hamedan University of Medical Sciences
Outcome results
None listed