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| Name | Class |
|---|---|
| LabviVale | OTHER |
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Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters. 44 patients will be divided into 2 groups: Diabetic Patients with Chronic Periodontitis (DM2DP) and Diabetic Patients without Chronic Periodontitis (DM2). The DM2DP group will receive periodontal debridement and DM2 group will be treated with supragingival scaling. Both groups receive board control every 3 months. At baseline, 3 and 6 months after treatment, will be held making the clinical periodontal parameters (plaque index, gingival index, probing depth, gingival recession relative clinical attachment level and Periodontal Inflamed Surface Area (PISA) index) and blood collection for assessment serum inflammatory markers (oxLDL, LDL, HDL, total cholesterol, triglyceride, Interleukin (IL) IL-6, IL-8, IL-10, Tumor Necrosis Factor (TNF-α) and CRP). Biochemical analyzes will be carried out by Z-scan technique. The data obtained before and after periodontal therapy will be analyzed using the Shapiro-Wilk test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Type 2 diabetes mellitus and periodontitis | Sham Comparator | periodontal debridement in a single session. |
|
| Type 2 diabetes mellitus and without periodontitis | No Intervention | maintained every three months. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical periodontal treatment | Procedure | Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment . |
| Measure | Description | Time Frame |
|---|---|---|
| Probing depth change | The change in the probing depth will be measure in millimeters before and after the treatment. | baseline, 90 and 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| oxLDL concentration Change | Change in concentration of oxLDL will be measured before and treatment. | baseline and 180 days |
| LDL, HDL, Total cholesterol, Triacylglycerol | Blood concentration (g/ml) will be measured before and after periodontal therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Jardini, PhD | Universidade Estadual Paulista Julio de Mesquita Filho | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| São Jose Dos Campos | São Paulo | 12245 000 | Brazil |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D003924 | Diabetes Mellitus, Type 2 |
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
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Prospective double-blind controlled clinical study with a 6-month follow-up.
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| baseline and 180 days |
| Plaque index | Number of teeth affected before and after periodontal treatment | baseline, 90 and 180 days |
| Gingival index | number of teeth affected before and after periodontal treatment | baseline, 90 and 180 days |
| Gingival Recession | Evaluated in millimeters before and after the treatment. | baseline, 90 and 180 days |
| Clinical Attachment Level | Evaluated in millimeters before and after the treatment. | baseline, 90 and 180 days |
| D008659 |
| Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |