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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Periodontitis
• Intervention / Treatment: Procedure: Non-surgical periodontal treatment

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Federal University of Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Healthy
EXPERIMENTAL: Periodontitis without diabetes	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.
EXPERIMENTAL: Periodontitis compensated diabetes	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.
EXPERIMENTAL: Periodontitis decompensated diabetes	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.
NO_INTERVENTION: Compensated diabetes non periodontitis
NO_INTERVENTION: Decompensated diabetes non periodontitis

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Minas Gerais
• Investigators: Principal Investigator: Fernando O Costa, PhD, Dean periodontics department

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2014
• Primary Completion (ACTUAL): June 20, 2017
• Study Completion (ACTUAL): June 28, 2017

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: May 8, 2017
• First Posted (ACTUAL): May 10, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 2, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes mellitus; Chronic periodontitis; Non-surgical periodontal therapy; Beta-defensins
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Diabetes Mellitus; Periodontitis
• Other Study ID Numbers: Beta defensins in periodontics

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared. Only data without identification will be submitted to statistical analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No