Diabetes Mellitus, Periodontitis
Conditions
Keywords
Beta-defensins, Chronic periodontitis, Diabetes mellitus, Non-surgical periodontal therapy
Brief summary
Human immune system produces many different factors, which will influence health-disease statuses. This partially explains why under similar conditions only some people become sick. Therefore, specific analyses of such factors in healthy and diseased patients are crucial for a better knowledge about diseases development and successful treatments. Human beta defensins (hBD) may have a key role in patient's susceptibility to gum diseases. In the lab, high levels of sugar (glucose) could inhibit their expression and contribute to the occurrence of infections associated with diabetic wounds. This study will evaluate if treatment of the most common gum disease in adults influences production of beta defensins by gingiva. Also, clinical improvements and treatment effects on blood glycemic levels will be monitored throughout a 2-month period. Patients with or without gum diseases and with or without diabetes mellitus will be able to participate. After a complete oral examination to determine periodontal status, gingival fluid samples will be collected using paper strips. These samples will be collected before and also two-months after oral treatment and will be analyzed by an immune-enzymatic test named ELISA (Enzyme-Linked Immunosorbent Assay). In weekly sections, one trained specialist will performed treatment of gum diseases under local anesthesia using hand-instruments. Researchers hypothesized that a) levels of defensins would be lower in the presence of periodontal disease when compared to a healthy periodontal condition; b) diabetes would influence production of these immune protective factors; and c) treatment would provide a greater beneficial amount of defensins.
Interventions
PROCEDURENon-surgical periodontal treatment
Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.
Sponsors
Federal University of Minas Gerais
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Periodontally healthy individuals: at least 15 natural teeth, periodontal pocket depth (PPD) ≤ 3mm e absence of bleeding on probing. * Periodontitis individuals: at least 15 natural teeth and at least 4 teeth with one or more periodontal sites showing combined PPD ≥ 4mm and clinical attachment level (CAL) ≥ 3mm. * Compensated diabetic individuals: compensated type 2 diabetes mellitus * Decompensated diabetic individuals: decompensated type 2 diabetes mellitus (glycated hemoglobin HbA1c \>7%)
Exclusion criteria
* Past or actual systemic diseases other than diabetes type 2 in the diabetic groups * Gingivitis * Gingival overgrowth * Necrotizing periodontal diseases * Pregnant or lactating * smokers or former-smokers * medication that can influence periodontal status or host response to periodontal therapy * periodontal therapy in the past 6 months from baseline * use of systemic or local antibiotics or anti-inflammatory drugs within 3 months prior baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in beta defensins 1, 2 and 3 | Baseline and 60 days | Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in periodontal pocket depth | Baseline and 60 days | Reduction in mean periodontal pocket depth |
| Changes in blood glycemic levels | Baseline and 60 days | Reduction in blood glucose levels and levels of glycated hemoglobin |
| Changes in percentage of diseased sites | Baseline and 60 days | Reduction in the percentage of sites showing PPD\>4mm and/or bleeding on probing |
Countries
Brazil
Outcome results
None listed