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Clinical Trials/NCT03146975
NCT03146975
Completed
Not Applicable

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

Federal University of Minas Gerais1 site in 1 country120 target enrollmentMarch 2, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontitis
Sponsor
Federal University of Minas Gerais
Enrollment
120
Locations
1
Primary Endpoint
Changes in beta defensins 1, 2 and 3
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2, 2014
End Date
June 28, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Minas Gerais
Responsible Party
Principal Investigator
Principal Investigator

Fernando O Costa

Head of periodontology

Federal University of Minas Gerais

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • Changes in blood glycemic levels(Baseline and 60 days)
  • Changes in percentage of diseased sites(Baseline and 60 days)
  • Changes in periodontal pocket depth(Baseline and 60 days)

Study Sites (1)

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