Effects of Gum Disease Treatment on Host Defense Factors (PETREBED)

Federal University of Minas Gerais

Status: Completed

Conditions: Periodontitis; Diabetes Mellitus

Treatments: Procedure: Non-surgical periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03146975

Beta defensins in periodontics

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 6 patient groups

Healthy

No Intervention group

Periodontitis without diabetes

Experimental group

Treatment:

Procedure: Non-surgical periodontal treatment

Periodontitis compensated diabetes

Experimental group

Treatment:

Procedure: Non-surgical periodontal treatment

Periodontitis decompensated diabetes

Experimental group

Treatment:

Procedure: Non-surgical periodontal treatment

Compensated diabetes non periodontitis

No Intervention group

Decompensated diabetes non periodontitis

No Intervention group