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

NCT ID: NCT01475435

Last Updated: 2011-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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chronic periodontitis

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

Group Type ACTIVE_COMPARATOR

non- surgical periodontal treatment

Intervention Type PROCEDURE

scaling and root planning

periodontally healthy individuals

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

Group Type PLACEBO_COMPARATOR

Prophylaxis

Intervention Type PROCEDURE

Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.

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

Group Type ACTIVE_COMPARATOR

non- surgical periodontal treatment

Intervention Type PROCEDURE

scaling and root planning

periodontally healthy individuals with diabetes type 2

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

Group Type PLACEBO_COMPARATOR

Prophylaxis

Intervention Type PROCEDURE

Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.

Interventions

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non- surgical periodontal treatment

scaling and root planning

Intervention Type PROCEDURE

Prophylaxis

Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role collaborator

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Luiz Antonio Pugliesi Alves de Lima

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Luiz A Lima, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

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University of São Paulo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Luiz Antônio Pugliesi Alves de Lima, PhD

Role: CONTACT

Phone: 55-11-30917833

Email: [email protected]

Ana Paula Sassá Benedete

Role: CONTACT

Phone: 55-11-30917833

Email: [email protected]

Facility Contacts

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Luiz Antônio Pugliesi Alves de Lima, PhD

Role: primary

Ana Paula Sassá Benedete

Role: backup

Other Identifiers

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DMSAL2712

Identifier Type: -

Identifier Source: org_study_id