Effects of Gum Disease Treatment on Host Defense Factors

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial

Conditions
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Periodontitis, Diabetes Mellitus

Intervention / Treatment
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* Procedure: Non-surgical periodontal treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Healthy<br> | |
| Experimental: Periodontitis without diabetes<br> | Procedure: Non-surgical periodontal treatment<br>* Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.<br>|
| Experimental: Periodontitis compensated diabetes<br> | Procedure: Non-surgical periodontal treatment<br>* Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.<br>|
| Experimental: Periodontitis decompensated diabetes<br> | Procedure: Non-surgical periodontal treatment<br>* Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.<br>|
| No Intervention: Compensated diabetes non periodontitis<br> | |
| No Intervention: Decompensated diabetes non periodontitis<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in beta defensins 1, 2 and 3 | Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples | Baseline and 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in periodontal pocket depth | Reduction in mean periodontal pocket depth | Baseline and 60 days | 
| Changes in blood glycemic levels | Reduction in blood glucose levels and levels of glycated hemoglobin | Baseline and 60 days | 
| Changes in percentage of diseased sites | Reduction in the percentage of sites showing PPD>4mm and/or bleeding on probing | Baseline and 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Beta-defensins, Chronic periodontitis, Diabetes mellitus, Non-surgical periodontal therapy