oxLDL in Diabetes Mellitus Patients and Disease Periodontal

NCT ID: NCT03198832

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-02
• Study Completion Date: 2017-01-28

Brief Summary

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

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.

Conditions

Type 2 Diabetes Mellitus With Periodontal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Type 2 diabetes mellitus and periodontitis

periodontal debridement in a single session.

Group Type: SHAM_COMPARATOR

Non-surgical periodontal treatment

Intervention Type: PROCEDURE

Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .

Type 2 diabetes mellitus and without periodontitis

maintained every three months.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Non-surgical periodontal treatment

Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LabviVale

OTHER

Sponsor Role: collaborator

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Maria Aparecida Neves Jardini

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Jardini, PhD

Role: STUDY_DIRECTOR

Universidade Estadual Paulista Julio de Mesquita Filho

Locations

São Jose Dos Campos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAAE:53785516.6.0000.0077

Identifier Type: -

Identifier Source: org_study_id