Clinical trial NCT03198832: oxLDL in Diabetes Mellitus Patients and Disease Periodontal
Official title: Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus With Periodontal Disease
Keywords: Periodontal Disease
Type 2 Diabetes Mellitus
Z-scan
Atherosclerosis
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
Collaborators: name: LabviVale
First posted: 2017-06-26
Enrollment: 44
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective double-blind controlled clinical study with a 6-month follow-up.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Probing depth change
timeFrame: baseline, 90 and 180 days
Secondary outcomes:
measure: oxLDL concentration Change
timeFrame: baseline and 180 days
measure: LDL, HDL, Total cholesterol, Triacylglycerol
timeFrame: baseline and 180 days
measure: Plaque index
timeFrame: baseline, 90 and 180 days
measure: Gingival index
timeFrame: baseline, 90 and 180 days
measure: Gingival Recession
timeFrame: baseline, 90 and 180 days
measure: Clinical Attachment Level
timeFrame: baseline, 90 and 180 days
Other outcomes:
Locations:
city: São Jose dos Campos
country: Brazil
state: São Paulo
Study officials:
affiliation: Universidade Estadual Paulista Julio de Mesquita Filho
name: Maria Jardini, PhD
role: STUDY_DIRECTOR
References: