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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients With Generalized Chronic Periodontitis and Healthy Periodontium

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01475435
• Other study ID #: DMSAL2712
• Status: Recruiting
• Phase: Phase 0
• First received: August 22, 2011
• Last updated: November 16, 2011
• Start date: August 2011
• Est. completion date: August 2013

Study information

• Verified date: August 2011
• Source: University of Sao Paulo
• Contact: Luiz Antônio Pugliesi Alves de Lima, PhD
• Phone: 55-11-30917833
• Email: lapalima[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Procedure:
• non- surgical periodontal treatment
scaling and root planning
• Prophylaxis
Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.

Locations

Country	Name	City	State
Brazil	University of São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo	Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline and 4 weeks after periodontal treatment	Yes