oxLDL in Diabetes Mellitus Patients and Disease Periodontal

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients

Conditions
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Type 2 Diabetes Mellitus With Periodontal Disease

Intervention / Treatment
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* Procedure: Non-surgical periodontal treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: individuals older than 35 years with DM2 diagnosed for more than five years and HbA1c between 7% and 11%; be diagnosed with generalized chronic periodontitis: present at least 6 sites with periodontal pocket and loss of insertion above 5mm and two more bags with loss of insertion above 6mm; present at least 20 teeth; agree to participate in the study and sign the informed consent form Exclusion Criteria: patients with cardiovascular diseases, cancer, gastrointestinal disorders, skin diseases, pregnancy, lactation, smoking, arthritis, lupus or other diseases of inflammatory origin; have undergone periodontal treatment in the last 12 months; have made use of antioxidant supplements, anti-inflammatories, or antibiotics within the previous 3 months; make use of medications that can alter the marking and concentration of oxLDL, for example, statins; have changed the medication for glycemic control in the last 3 months; present dental elements with pulpal or periapical inflammation.

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective double-blind controlled clinical study with a 6-month follow-up.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Type 2 diabetes mellitus and periodontitis<br>periodontal debridement in a single session. | Procedure: Non-surgical periodontal treatment<br>* Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .<br>|
| No Intervention: Type 2 diabetes mellitus and without periodontitis<br>maintained every three months. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal Disease, Type 2 Diabetes Mellitus, Z-scan, Atherosclerosis