Back to resultsEffect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2
Primary Purpose
Chronic Periodontitis, Diabetes Type 2
Status
Terminated
Phase
Locations
Brazil
Study Type
Observational
Intervention
Mechanical periodontal therapy
nonsurgical periodontal therapy
Sponsored by
About this trial
This is an observational trial for Chronic Periodontitis
Eligibility 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.
Sites / Locations
- Priscilla Farias Naiff
Arms of the Study
Arm 1
Arm Type
Arm Label
root planning
Arm Description
Outcomes
Primary Outcome Measures
Evidence of alteration in periodontal pathogens by PCR
Evaluate wich periodontal pathogens are detected before and after treatment
Evidence of alteration of immunocellular response by flowcytometry
Fenotype Monocytes, PMN, NK cells, T cells, B cells before and after periodontal treatment
Evidence of alteration on pro and anti-inflammatory cytokines by CBA
Dosage of cytokines before and after periodontal treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT02589314
First Posted
October 26, 2015
Last Updated
August 20, 2020
Sponsor
University of Brasilia
Collaborators
Catholic University of Brasília, Brasilia University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02589314
Brief Title
Effect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2
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
Study Type
Observational
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Terminated
Why Stopped
We could not achieve the number of participants necessary to continue with the study and limited money to continue with the study
Study Start Date
November 2015 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
August 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Brasilia
Collaborators
Catholic University of Brasília, Brasilia University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis, Diabetes Type 2
7. Study Design
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
root planning
Intervention Type
Device
Intervention Name(s)
Mechanical periodontal therapy
Other Intervention Name(s)
periodontal debridment
Intervention Type
Procedure
Intervention Name(s)
nonsurgical periodontal therapy
Primary Outcome Measure Information:
Title
Evidence of alteration in periodontal pathogens by PCR
Description
Evaluate wich periodontal pathogens are detected before and after treatment
Time Frame
One year
Title
Evidence of alteration of immunocellular response by flowcytometry
Description
Fenotype Monocytes, PMN, NK cells, T cells, B cells before and after periodontal treatment
Time Frame
one year
Title
Evidence of alteration on pro and anti-inflammatory cytokines by CBA
Description
Dosage of cytokines before and after periodontal treatment
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Priscilla Farias Naiff
City
Brasilia
State/Province
Distrito Federal
ZIP/Postal Code
70790-123
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Effect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2
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