search
Back to results

Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients

Primary Purpose

Diabetes Mellitus Type 2

Status
Unknown status
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
non- surgical periodontal treatment
Prophylaxis
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus Type 2

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with type 2 diabetes and chronic periodontitis(more than 30% of the sites involved, AAP, 1999)
  • Patients with type 2 diabetes and periodontally healthy (AAP, 1999)
  • Patients systemically healthy with chronic periodontitis (more than 30% of the sites involved)
  • Patients systemically and periodontally healthy
  • Patients with at least 15 natural teeth (excluding 3rd molars).
  • At least 30% of sites with probing pocket depth (PD)> 5 mm and a maximum of 60% sites with PS <7 mm
  • Clinical attachment level (CAL)> 4 mm
  • Visible plaque and bleeding on probing (BOP)
  • Patients with type 2 diabetes have to bear the disease for at least five years and have to show a blood percentage of glycated hemoglobin between 6.5% to 8% (UKPDS 1998) at baseline

Exclusion Criteria

  • Individuals with periodontal pockets deeper than 7 mm
  • Patients with any other systemic disease (except diabetes type 2)
  • Patients who have used medications such as anticoagulants, contraceptives or antidepressants in the past 6 months
  • Patients who have used antibiotic and anti-inflammatory drugs in the last 3 months before the of the study
  • Smoking
  • Pregnancy
  • Patients who have received periodontal treatment in the last six months before the start of this study.

Sites / Locations

  • University of São PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

chronic periodontitis

periodontally healthy individuals

chronic periodontitis with diabetes type 2

periodontally healthy individuals with diabetes type 2

Arm Description

Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis.

Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline.

Saliva and GCF samples will be evaluated before and after treatment from patients with diabetes type 2 treated of chronic periodontitis

Saliva and GCF samples will be evaluated from periodontally healthy individuals with diabetes type 2 at baseline

Outcomes

Primary Outcome Measures

Evaluate level change of oxidative stress biomarkers in crevicular gingival fluid and whole saliva on diabetes type 2 individuals
The participants will be followed for an expected average of 4 weeks after periodontal treatment. The samples of saliva and crevicular gingival fluid will be evaluated at baseline and four weeks after periodontal treatment.

Secondary Outcome Measures

Full Information

First Posted
August 22, 2011
Last Updated
November 16, 2011
Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo
search

1. Study Identification

Unique Protocol Identification Number
NCT01475435
Brief Title
Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients
Official Title
Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients With Generalized Chronic Periodontitis and Healthy Periodontium
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
August 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Abstract Diabetes mellitus and periodontal diseases are both chronic inflammatory disorders that have a major impact on the health and well being of millions of individuals worldwide. Periodontal diseases are among the most common diseases in humans, therefore, if the presence of periodontal diseases plays any role in overall systemic health, the public health impact may be substantial. An important factor that can be involved in the progression of the periodontal disease is the production of Reactive Oxygen Species (ROS). The imbalance between oxidative stress induced by ROS and the concentrations (or activity) of the antioxidant may result in tissue damage. The ROS induce the activity of lipid peroxidation-Tbars, myeloperoxidase (MPO), peroxidase and arginase, whose mechanisms reflect the severity of the periodontal disease and it may offer the basis for a patient specific diagnostic test for periodontitis and could have therapeutic significance. The aim of this study is to investigate quantitatively the levels of oxidative stress markers (Myeloperoxidase, Peroxidase, Lipid Peroxidation and Arginase) in saliva and in gingival crevicular fluid (GCF) of diabetes type 2 subjects with generalized chronic periodontitis and periodontally healthy individuals, and systematically healthy individuals with generalized chronic periodontitis and periodontally healthy individuals, before and after periodontal treatment. Unstimulated whole saliva will be collected for 5 min as well as GCF of 25 diabetes type 2 with generalized chronic periodontitis, 25 diabetes type 2 periodontally healthy individuals as controls, 25 systematically healthy individuals with generalized chronic periodontitis and 25 periodontally healthy individuals before and after treatment. The following clinical parameters will be evaluated: probing pocket depth, probing attachment level, plaque index and the gingival index. The activity of stress markers in saliva and GFC will be analyzed by spectrophotometry. Adequate statistical analysis will be carried out with a p-value set at p < 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 2

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chronic periodontitis
Arm Type
Active Comparator
Arm Description
Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis.
Arm Title
periodontally healthy individuals
Arm Type
Placebo Comparator
Arm Description
Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline.
Arm Title
chronic periodontitis with diabetes type 2
Arm Type
Active Comparator
Arm Description
Saliva and GCF samples will be evaluated before and after treatment from patients with diabetes type 2 treated of chronic periodontitis
Arm Title
periodontally healthy individuals with diabetes type 2
Arm Type
Placebo Comparator
Arm Description
Saliva and GCF samples will be evaluated from periodontally healthy individuals with diabetes type 2 at baseline
Intervention Type
Procedure
Intervention Name(s)
non- surgical periodontal treatment
Intervention Description
scaling and root planning
Intervention Type
Procedure
Intervention Name(s)
Prophylaxis
Intervention Description
Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
Primary Outcome Measure Information:
Title
Evaluate level change of oxidative stress biomarkers in crevicular gingival fluid and whole saliva on diabetes type 2 individuals
Description
The participants will be followed for an expected average of 4 weeks after periodontal treatment. The samples of saliva and crevicular gingival fluid will be evaluated at baseline and four weeks after periodontal treatment.
Time Frame
baseline and 4 weeks after periodontal treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with type 2 diabetes and chronic periodontitis(more than 30% of the sites involved, AAP, 1999) Patients with type 2 diabetes and periodontally healthy (AAP, 1999) Patients systemically healthy with chronic periodontitis (more than 30% of the sites involved) Patients systemically and periodontally healthy Patients with at least 15 natural teeth (excluding 3rd molars). At least 30% of sites with probing pocket depth (PD)> 5 mm and a maximum of 60% sites with PS <7 mm Clinical attachment level (CAL)> 4 mm Visible plaque and bleeding on probing (BOP) Patients with type 2 diabetes have to bear the disease for at least five years and have to show a blood percentage of glycated hemoglobin between 6.5% to 8% (UKPDS 1998) at baseline Exclusion Criteria Individuals with periodontal pockets deeper than 7 mm Patients with any other systemic disease (except diabetes type 2) Patients who have used medications such as anticoagulants, contraceptives or antidepressants in the past 6 months Patients who have used antibiotic and anti-inflammatory drugs in the last 3 months before the of the study Smoking Pregnancy Patients who have received periodontal treatment in the last six months before the start of this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luiz Antônio Pugliesi Alves de Lima, PhD
Phone
55-11-30917833
Email
lapalima@usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Paula Sassá Benedete
Phone
55-11-30917833
Email
abenedete@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz A Lima, PhD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
University of São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
05508-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luiz Antônio Pugliesi Alves de Lima, PhD
Phone
55-11-30917833
Email
lapalima@usp.br
First Name & Middle Initial & Last Name & Degree
Ana Paula Sassá Benedete
Phone
55-11-30917833
Email
abenedete@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients

We'll reach out to this number within 24 hrs