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oxLDL in Diabetes Mellitus Patients and Disease Periodontal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03198832
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
LabviVale
Information provided by (Responsible Party):
Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus With Periodontal Disease Procedure: Non-surgical periodontal treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective double-blind controlled clinical study with a 6-month follow-up.
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : August 26, 2016
Actual Study Completion Date : January 28, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Sham Comparator: Type 2 diabetes mellitus and periodontitis
periodontal debridement in a single session.
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 .

No Intervention: Type 2 diabetes mellitus and without periodontitis
maintained every three months.



Primary Outcome Measures :
  1. Probing depth change [ Time Frame: baseline, 90 and 180 days ]
    The change in the probing depth will be measure in millimeters before and after the treatment.


Secondary Outcome Measures :
  1. oxLDL concentration Change [ Time Frame: baseline and 180 days ]
    Change in concentration of oxLDL will be measured before and treatment.

  2. LDL, HDL, Total cholesterol, Triacylglycerol [ Time Frame: baseline and 180 days ]
    Blood concentration (g/ml) will be measured before and after periodontal therapy.

  3. Plaque index [ Time Frame: baseline, 90 and 180 days ]
    Number of teeth affected before and after periodontal treatment

  4. Gingival index [ Time Frame: baseline, 90 and 180 days ]
    number of teeth affected before and after periodontal treatment

  5. Gingival Recession [ Time Frame: baseline, 90 and 180 days ]
    Evaluated in millimeters before and after the treatment.

  6. Clinical Attachment Level [ Time Frame: baseline, 90 and 180 days ]
    Evaluated in millimeters before and after the treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198832


Locations
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Brazil
São Jose dos Campos, São Paulo, Brazil, 12245 000
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
LabviVale
Investigators
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Study Director: Maria Jardini, PhD Universidade Estadual Paulista Julio de Mesquita Filho

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Responsible Party: Maria Aparecida Neves Jardini, Professor, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT03198832    
Other Study ID Numbers: CAAE:53785516.6.0000.0077
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Maria Aparecida Neves Jardini, Universidade Estadual Paulista Júlio de Mesquita Filho:
Periodontal Disease
Type 2 Diabetes Mellitus
Z-scan
Atherosclerosis
Additional relevant MeSH terms:
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Periodontal Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases