oxLDL in Diabetes Mellitus Patients and Disease Periodontal
Primary Purpose
Type 2 Diabetes Mellitus With Periodontal Disease
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Non-surgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus With Periodontal Disease focused on measuring Periodontal Disease, Type 2 Diabetes Mellitus, Z-scan, Atherosclerosis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
No Intervention
Arm Label
Type 2 diabetes mellitus and periodontitis
Type 2 diabetes mellitus and without periodontitis
Arm Description
periodontal debridement in a single session.
maintained every three months.
Outcomes
Primary Outcome Measures
Probing depth change
The change in the probing depth will be measure in millimeters before and after the treatment.
Secondary Outcome Measures
oxLDL concentration Change
Change in concentration of oxLDL will be measured before and treatment.
LDL, HDL, Total cholesterol, Triacylglycerol
Blood concentration (g/ml) will be measured before and after periodontal therapy.
Plaque index
Number of teeth affected before and after periodontal treatment
Gingival index
number of teeth affected before and after periodontal treatment
Gingival Recession
Evaluated in millimeters before and after the treatment.
Clinical Attachment Level
Evaluated in millimeters before and after the treatment.
Full Information
NCT ID
NCT03198832
First Posted
February 6, 2017
Last Updated
November 11, 2018
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
LabviVale
1. Study Identification
Unique Protocol Identification Number
NCT03198832
Brief Title
oxLDL in Diabetes Mellitus Patients and Disease Periodontal
Official Title
Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2016 (Actual)
Primary Completion Date
August 26, 2016 (Actual)
Study Completion Date
January 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Collaborators
LabviVale
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus With Periodontal Disease
Keywords
Periodontal Disease, Type 2 Diabetes Mellitus, Z-scan, Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective double-blind controlled clinical study with a 6-month follow-up.
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Type 2 diabetes mellitus and periodontitis
Arm Type
Sham Comparator
Arm Description
periodontal debridement in a single session.
Arm Title
Type 2 diabetes mellitus and without periodontitis
Arm Type
No Intervention
Arm Description
maintained every three months.
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal treatment
Intervention Description
Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .
Primary Outcome Measure Information:
Title
Probing depth change
Description
The change in the probing depth will be measure in millimeters before and after the treatment.
Time Frame
baseline, 90 and 180 days
Secondary Outcome Measure Information:
Title
oxLDL concentration Change
Description
Change in concentration of oxLDL will be measured before and treatment.
Time Frame
baseline and 180 days
Title
LDL, HDL, Total cholesterol, Triacylglycerol
Description
Blood concentration (g/ml) will be measured before and after periodontal therapy.
Time Frame
baseline and 180 days
Title
Plaque index
Description
Number of teeth affected before and after periodontal treatment
Time Frame
baseline, 90 and 180 days
Title
Gingival index
Description
number of teeth affected before and after periodontal treatment
Time Frame
baseline, 90 and 180 days
Title
Gingival Recession
Description
Evaluated in millimeters before and after the treatment.
Time Frame
baseline, 90 and 180 days
Title
Clinical Attachment Level
Description
Evaluated in millimeters before and after the treatment.
Time Frame
baseline, 90 and 180 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Jardini, PhD
Organizational Affiliation
Universidade Estadual Paulista Julio de Mesquita Filho
Official's Role
Study Director
Facility Information:
City
São Jose dos Campos
State/Province
São Paulo
ZIP/Postal Code
12245 000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
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oxLDL in Diabetes Mellitus Patients and Disease Periodontal
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