oxLDL in Diabetes Mellitus Patients and Disease Periodontal

Universidade Estadual Paulista Júlio de Mesquita Filho

Status: Completed

Conditions: Type 2 Diabetes Mellitus With Periodontal Disease

Treatments: Procedure: Non-surgical periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03198832

CAAE:53785516.6.0000.0077

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 44 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups

Type 2 diabetes mellitus and periodontitis

Sham Comparator group

Description:

periodontal debridement in a single session.

Treatment:

Procedure: Non-surgical periodontal treatment

Type 2 diabetes mellitus and without periodontitis

No Intervention group

Description:

maintained every three months.