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

Primary Purpose

Periodontitis, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis focused on measuring Beta-defensins, Chronic periodontitis, Diabetes mellitus, Non-surgical periodontal therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Federal university of minas gerais

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Experimental

Experimental

Experimental

No Intervention

No Intervention

Arm Label

Healthy

Periodontitis without diabetes

Periodontitis compensated diabetes

Periodontitis decompensated diabetes

Compensated diabetes non periodontitis

Decompensated diabetes non periodontitis

Arm Description

Outcomes

Primary Outcome Measures

Changes in beta defensins 1, 2 and 3
Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples

Secondary Outcome Measures

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

Full Information

First Posted
May 8, 2017
Last Updated
June 28, 2017
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT03146975
Brief Title
Effects of Gum Disease Treatment on Host Defense Factors
Acronym
PETREBED
Official Title
Effects of Non-surgical Periodontal Treatment on Gingival Beta Defensins in Different Clinical Conditions : a Short-term Clinica Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2, 2014 (Actual)
Primary Completion Date
June 20, 2017 (Actual)
Study Completion Date
June 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Diabetes Mellitus
Keywords
Beta-defensins, Chronic periodontitis, Diabetes mellitus, Non-surgical periodontal therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy
Arm Type
No Intervention
Arm Title
Periodontitis without diabetes
Arm Type
Experimental
Arm Title
Periodontitis compensated diabetes
Arm Type
Experimental
Arm Title
Periodontitis decompensated diabetes
Arm Type
Experimental
Arm Title
Compensated diabetes non periodontitis
Arm Type
No Intervention
Arm Title
Decompensated diabetes non periodontitis
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.
Primary Outcome Measure Information:
Title
Changes in beta defensins 1, 2 and 3
Description
Increase in the expression of beta defensins 1, 2 and 3 in gingival crevicular fluid samples
Time Frame
Baseline and 60 days
Secondary Outcome Measure Information:
Title
Changes in periodontal pocket depth
Description
Reduction in mean periodontal pocket depth
Time Frame
Baseline and 60 days
Title
Changes in blood glycemic levels
Description
Reduction in blood glucose levels and levels of glycated hemoglobin
Time Frame
Baseline and 60 days
Title
Changes in percentage of diseased sites
Description
Reduction in the percentage of sites showing PPD>4mm and/or bleeding on probing
Time Frame
Baseline and 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando O Costa, PhD
Organizational Affiliation
Dean periodontics department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal university of minas gerais
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared. Only data without identification will be submitted to statistical analysis.

Learn more about this trial

Effects of Gum Disease Treatment on Host Defense Factors

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