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| Name | Class |
|---|---|
| Federal University of São Paulo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| chronic periodontitis | Active Comparator | Saliva and GCF samples will be evaluated before and after treatment from patients treated of chronic periodontitis. |
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| periodontally healthy individuals | Placebo Comparator | Saliva and GCF samples will be evaluated from periodontally healthy individuals at baseline. |
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| chronic periodontitis with diabetes type 2 | Active Comparator | Saliva and GCF samples will be evaluated before and after treatment from patients with diabetes type 2 treated of chronic periodontitis |
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| periodontally healthy individuals with diabetes type 2 | Placebo Comparator | Saliva and GCF samples will be evaluated from periodontally healthy individuals with diabetes type 2 at baseline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non- surgical periodontal treatment | Procedure | scaling and root planning |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luiz Antônio Pugliesi Alves de Lima, PhD | Contact | 55-11-30917833 | lapalima@usp.br | |
| Ana Paula Sassá Benedete | Contact | 55-11-30917833 | abenedete@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Luiz A Lima, PhD | University of Sao Paulo | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of São Paulo | Recruiting | São Paulo | São Paulo | 05508-000 | Brazil |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Prophylaxis | Procedure | Periodontally healthy patients will receive oral hygiene instructions and prophylaxis. |
|
| D004700 | Endocrine System Diseases |