Status:

UNKNOWN

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

Lead Sponsor:

University of Sao Paulo

Collaborating Sponsors:

Federal University of São Paulo

Conditions:

Diabetes Mellitus Type 2

Eligibility:

All Genders

30-70 years

Phase:

EARLY_PHASE1

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 dise...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    August 1 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 1 2013

    Estimated Enrollment :

    200 Patients enrolled

    Trial Details

    Trial ID

    NCT01475435

    Start Date

    August 1 2011

    End Date

    August 1 2013

    Last Update

    November 21 2011

    Active Locations (1)

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    1

    University of São Paulo

    São Paulo, São Paulo, Brazil, 05508-000