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OpenTrials
Completed

NCT Number: NCT03198832

oxLDL in Diabetes Mellitus Patients and Disease Periodontal

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-surgical periodontal treatment

Procedure

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho

Other

Collaborators

  • LabviVale

Registry information

Official study title

Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Jun 26, 2017
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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