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

This study is currently recruiting participants.
Verified August 2011 by University of Sao Paulo
Sponsor:
Collaborator:
Federal University of São Paulo
Information provided by (Responsible Party):
Luiz Antonio Pugliesi Alves de Lima, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01475435
First received: August 22, 2011
Last updated: November 16, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus Type 2
 Procedure: non- surgical periodontal treatment
Procedure: Prophylaxis
 Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients With Generalized Chronic Periodontitis and Healthy Periodontium

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Evaluate level change of oxidative stress biomarkers in crevicular gingival fluid and whole saliva on diabetes type 2 individuals [ Time Frame: baseline and 4 weeks after periodontal treatment ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: chronic periodontitis
Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis.
 Procedure: non- surgical periodontal treatment
scaling and root planning
Placebo Comparator: periodontally healthy individuals
Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline.
 Procedure: Prophylaxis
Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
Active Comparator: chronic periodontitis with diabetes type 2
Saliva and GCF samples will be evaluated before and after treatment from patients with diabetes type 2 treated of chronic periodontitis
 Procedure: non- surgical periodontal treatment
scaling and root planning
Placebo Comparator: periodontally healthy individuals with diabetes type 2
Saliva and GCF samples will be evaluated from periodontally healthy individuals with diabetes type 2 at baseline
 Procedure: Prophylaxis
Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01475435

Contacts
Contact: Luiz Antônio Pugliesi Alves de Lima, PhD 55-11-30917833 lapalima@usp.br
Contact: Ana Paula Sassá Benedete 55-11-30917833 abenedete@gmail.com

Locations
Brazil
University of São Paulo Recruiting
São Paulo, SP, Brazil, 05508-000
Contact: Luiz Antônio Pugliesi Alves de Lima, PhD     55-11-30917833     lapalima@usp.br    
Contact: Ana Paula Sassá Benedete     55-11-30917833     abenedete@gmail.com    
Sponsors and Collaborators
University of Sao Paulo
Federal University of São Paulo
Investigators
Study Director: Luiz A Lima, PhD University of Sao Paulo
  More Information

No publications provided

Responsible Party: Luiz Antonio Pugliesi Alves de Lima, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01475435     History of Changes
Other Study ID Numbers: DMSAL2712
Study First Received: August 22, 2011
Last Updated: November 16, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Chronic Periodontitis
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on May 23, 2013