- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01475435
Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients
November 16, 2011 updated by: Luiz Antonio Pugliesi Alves de Lima, University of Sao Paulo
Oxidative Stress Markers Evaluation Before and After Periodontal Treatment of Diabetics Type 2 Patients With Generalized Chronic Periodontitis and Healthy Periodontium
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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SP
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São Paulo, SP, Brazil, 05508-000
- Recruiting
- University of Sao Paulo
-
Contact:
- Luiz Antônio Pugliesi Alves de Lima, PhD
- Phone Number: 55-11-30917833
- Email: lapalima@usp.br
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Contact:
- Ana Paula Sassá Benedete
- Phone Number: 55-11-30917833
- Email: abenedete@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: chronic periodontitis
Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis.
|
scaling and root planning
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Placebo Comparator: periodontally healthy individuals
Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline.
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Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
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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
|
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
|
Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Luiz A Lima, PhD, University of Sao Paulo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Anticipated)
December 1, 2011
Study Completion (Anticipated)
August 1, 2013
Study Registration Dates
First Submitted
August 22, 2011
First Submitted That Met QC Criteria
November 16, 2011
First Posted (Estimate)
November 21, 2011
Study Record Updates
Last Update Posted (Estimate)
November 21, 2011
Last Update Submitted That Met QC Criteria
November 16, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DMSAL2712
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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