oxLDL in Diabetes Mellitus Patients and Disease Periodontal

Type 2 Diabetes Mellitus With Periodontal Disease Clinical Trial

Official title:

Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03198832
• Other study ID #: CAAE:53785516.6.0000.0077
• Status: Completed
• Phase: N/A
• Start date: May 2, 2016
• Est. completion date: January 28, 2017

Study information

• Verified date: November 2018
• Source: Universidade Estadual Paulista Júlio de Mesquita Filho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 28, 2017
• Est. primary completion date: August 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Gingival Diseases
• Periodontal Diseases
• Type 2 Diabetes Mellitus With Periodontal Disease

Intervention

Procedure:
• Non-surgical periodontal treatment
Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidade Estadual Paulista Júlio de Mesquita Filho	LabviVale -Laboratory of clinical analyzes of Hospital viValle

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	oxLDL concentration Change	Change in concentration of oxLDL will be measured before and treatment.	baseline and 180 days
Secondary	LDL, HDL, Total cholesterol, Triacylglycerol	Blood concentration (g/ml) will be measured before and after periodontal therapy.	baseline and 180 days
Secondary	Plaque index	Number of teeth affected before and after periodontal treatment	baseline, 90 and 180 days
Secondary	Gingival index	number of teeth affected before and after periodontal treatment	baseline, 90 and 180 days
Secondary	Gingival Recession	Evaluated in millimeters before and after the treatment.	baseline, 90 and 180 days
Secondary	Clinical Attachment Level	Evaluated in millimeters before and after the treatment.	baseline, 90 and 180 days