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Effect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2

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ClinicalTrials.gov Identifier: NCT02589314
Recruitment Status : Terminated (We could not achieve the number of participants necessary to continue with the study and limited money to continue with the study)
First Posted : October 28, 2015
Last Update Posted : August 24, 2020
Sponsor:
Collaborators:
Catholic University of Brasília
Brasilia University Hospital
Information provided by (Responsible Party):
Priscilla Farias Naiff, University of Brasilia

Brief Summary:
This study will evaluate if periodontal mechanical treatment is capable to alter immunological and genetical parameters related to systemic health in patients with chronic periodontitis ant diabetes type 2.

Condition or disease Intervention/treatment
Chronic Periodontitis Diabetes Type 2 Device: Mechanical periodontal therapy Procedure: nonsurgical periodontal therapy

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Study Type : Observational
Actual Enrollment : 90 participants
Official Title: Effect of Mechanical Periodontal Therapy in the Microbiological, Immunocellular and Immunoglobulin Profiles and in the Dosage of Pro and Anti-inflammatory Cytokines From Peripheral Blood and Saliva of Subjects With Chronic Periodontitis and Diabetes Type 2
Actual Study Start Date : November 2015
Actual Primary Completion Date : September 2019
Actual Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
root planning Device: Mechanical periodontal therapy
Other Name: periodontal debridment

Procedure: nonsurgical periodontal therapy



Primary Outcome Measures :
  1. Evidence of alteration in periodontal pathogens by PCR [ Time Frame: One year ]
    Evaluate wich periodontal pathogens are detected before and after treatment

  2. Evidence of alteration of immunocellular response by flowcytometry [ Time Frame: one year ]
    Fenotype Monocytes, PMN, NK cells, T cells, B cells before and after periodontal treatment

  3. Evidence of alteration on pro and anti-inflammatory cytokines by CBA [ Time Frame: One year ]
    Dosage of cytokines before and after periodontal treatment



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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Periodontitis group:

  • Minimum of 15 teeh;
  • At least 30% of sites with periodontal probing depth ≥ 4 mm and at least two teeth with CAL ≥ 3 mm; Age ≥30 years;

Control group:

  • Systemically healthy;
  • 20 teeth;
  • Probing depth ≤3 mm, clinical attachment level ≤3 mm , ≤10% of sites with bleeding on probing.

Exclusion Criteria:

  • Periodontal treatment in the last six months;
  • Continued use of medications such as antibiotics, immunomodulatory, anti-inflammatory drugs or corticosteroids in the last three months;
  • Systemic diseases that interfere with periodontal condition, except for diabetes for the test group (HIV, cancer, immune disorders, acute infections, severe allergies, gastrointestinal or kidney disease, morbid obesity [BMI 40 kg / m2] or underweight [evil nourished BMI <18.5 kg / m2], etc.); Pregnant or lactating; smoking; Age <30 years; Indigenous groups.

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): NCT02589314


Locations
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Brazil
Priscilla Farias Naiff
Brasilia, Distrito Federal, Brazil, 70790-123
Sponsors and Collaborators
University of Brasilia
Catholic University of Brasília
Brasilia University Hospital
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Responsible Party: Priscilla Farias Naiff, PhD student, University of Brasilia
ClinicalTrials.gov Identifier: NCT02589314    
Other Study ID Numbers: CAAE 46609515.7.0000.0030
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases