Effects of Gum Disease Treatment on Host Defense Factors

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: June 20, 2017

Interventions

  • Procedure: Non-surgical periodontal treatment
    • Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.

Arms, Groups and Cohorts

  • No Intervention: Healthy
  • Experimental: Periodontitis without diabetes
  • Experimental: Periodontitis compensated diabetes
  • Experimental: Periodontitis decompensated diabetes
  • No Intervention: Compensated diabetes non periodontitis
  • No Intervention: Decompensated diabetes non periodontitis

Clinical Trial Outcome Measures

Primary Measures

  • Changes in beta defensins 1, 2 and 3
    • Time Frame: Baseline and 60 days
    • Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Federal University of Minas Gerais
  • Provider of Information About this Clinical Study
    • Principal Investigator: Fernando O Costa, Head of periodontology – Federal University of Minas Gerais
  • Overall Official(s)
    • Fernando O Costa, PhD, Principal Investigator, Dean periodontics department

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.