Study Stopped
We could not achieve the number of participants necessary to continue with the study and limited money to continue with the study
Effect of Periodontal Therapy in the Systemic Status of Individuals With Chronic Periodontitis and Diabetes Type 2
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
1 other identifier
observational
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2015
CompletedFirst Posted
Study publicly available on registry
October 28, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedAugust 24, 2020
August 1, 2020
3.8 years
October 26, 2015
August 20, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Evidence of alteration in periodontal pathogens by PCR
Evaluate wich periodontal pathogens are detected before and after treatment
One year
Evidence of alteration of immunocellular response by flowcytometry
Fenotype Monocytes, PMN, NK cells, T cells, B cells before and after periodontal treatment
one year
Evidence of alteration on pro and anti-inflammatory cytokines by CBA
Dosage of cytokines before and after periodontal treatment
One year
Study Arms (1)
root planning
Interventions
Eligibility Criteria
You may qualify if:
- 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;
- teeth;
- Probing depth ≤3 mm, clinical attachment level ≤3 mm , ≤10% of sites with bleeding on probing.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Brasilialead
- Catholic University of Brasíliacollaborator
- Brasilia University Hospitalcollaborator
Study Sites (1)
Priscilla Farias Naiff
Brasília, Federal District, 70790-123, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD student
Study Record Dates
First Submitted
October 26, 2015
First Posted
October 28, 2015
Study Start
November 1, 2015
Primary Completion
September 1, 2019
Study Completion
August 1, 2020
Last Updated
August 24, 2020
Record last verified: 2020-08