Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis
Primary Purpose
Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus, Periodontal Diseases
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Nonsurgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Subjects aged between 35 and 65 years
- Subject diagnosed with T2DM (HbA1C ≥6.5), prediabetic (HbA1C ≥5.7 and ≤6.4) and non-diabetic (HbA1C ≤5.6) according to American Diabetes Association, 2013.
- Subjects with GCP (PPD ≥5 mm in ≥10 teeth and BOP in ≥30% of sites) and without GCP (PPD ≤4mm and BOP in <30% sites)
- Non-smokers or former smokers ≥5 years after quitting
Exclusion Criteria:
- Pregnant or lactating women
- Subjects taking medications known to affect the periodontium including phenytoin, cyclosporine
- Subjects with immunosuppressive conditions or diseases including HIV infection or Hepatitis (B, C).
- Subjects who require antibiotic prophylaxis for dental procedures.
- Subjects who have taken antibiotics in the last 6 months
- Subjects taking daily NSAIDS or on steroidal anti- inflammatory medications
Sites / Locations
- University of Sao Paulo
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nonsurgical periodontal treatment
Arm Description
Nonsurgical periodontal treatment will be conducted following a full-mouth approach; no antibiotics or chemical plaque control will be provided.
Outcomes
Primary Outcome Measures
Change from baseline in cellular measures
Cellular measures: Blood PBMCs- counts of myeloid DC (BDCA-1+CD19-), Plasmacytoid DC (cd123+cd303+) NK (CD56+CD16+), Th17, Treg (CD25+, CD39,CD73,CD127, cd152)
Change from baseline in molecular measures
Molecular measures: (Serum/crevicular fluid/ saliva): Anti-mfa-1 IgG (ELISA), Levels of IDO-1, TGFβ, TNFα, IL-1β, IL-6, IL-2, IL-10, IL-17, IL-23, IFNγ, CXCL12 (SDF1) by Multiplexing Luminex immunoassay [MAGPIX®]), performed in triplicate
Change from baseline in the expression on mDCs
Expression on mDCs by custom qrt-PCR array (One step-fast cycle Taqman®, life technologiesTM of: angiopoietin-2, follistatin, GM-CSF, G-CSF, HGF, IL8, IL-6, leptin, PDGF-BB, PECAM-1, VEGF, TGFβ, IDO-1, IL-10, IL-1β, caspase-1, IL-17, IL-23, IL-23R IL-33, IL-12 p70, TRAIL, FOX01, Bcl-2, CXCL12 (SDF-1), CCL19, CCL21 analyzed in triplicate.
Secondary Outcome Measures
periodontal probing depth, periodontal attachment level, bleeding on probing, visible plaque and gingival bleeding.
Full Information
NCT ID
NCT02172716
First Posted
June 17, 2014
Last Updated
May 1, 2018
Sponsor
University of Sao Paulo
Collaborators
Augusta University
1. Study Identification
Unique Protocol Identification Number
NCT02172716
Brief Title
Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis
Official Title
Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Augusta University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective of this study is to assess the short-term immune response of type-2 diabetics with generalized chronic periodontitis (GCP) to nonsurgical periodontal treatment.
The investigators hypothesize that type-2 diabetes exacerbates the disruption of DC (dendritic cells)-mediated immune homeostasis associated with periodontitis.
Detailed Description
Objectives: The primary objective of this study is to assess the short-term immune response of type-2 diabetics with generalized chronic periodontitis (GCP) to nonsurgical periodontal treatment.
Hypothesis: we hypothesize that type-2 diabetes exacerbates the disruption of DC-mediated immune homeostasis associated with periodontitis.
Subject population: Four groups comprising 80 subjects will be selected to participate: type 2 diabetics with GCP (n=20), prediabetics with GCP (n=20), normoglycemics with GCP (n=20) and healthy controls (n=20).
Study design: discovery study nested within a single-arm, single blinded clinical trial.
Experimental periods: Screening/Baseline Visit, Treatment Visit, 24 hours, 30 days and 3 months after treatment.
Intervention: Nonsurgical periodontal treatment will be conducted following a full-mouth approach; no antibiotics or chemical plaque control will be provided.
Primary outcomes:
Cellular measures: Blood PBMCs- counts of myeloid DC (BDCA-1+CD19-), Plasmacytoid DC (cd123+cd303+) NK (CD56+CD16+), Th17, Treg (CD25+, CD39,CD73,CD127, cd152)
Molecular measures: (Serum/crevicular fluid/ saliva): Anti-mfa-1 IgG (ELISA), Levels of IDO-1, TGFβ, TNFα, IL-1β, IL-6, IL-2, IL-10, IL-17, IL-23, IFNγ, CXCL12 (SDF1) by Multiplexing Luminex immunoassay [MAGPIX®]), performed in triplicate
Expression on mDCs by custom qrt-PCR array (One step-fast cycle Taqman®, life technologiesTM of: angiopoietin-2, follistatin, GM-CSF, G-CSF, HGF, IL8, IL-6, leptin, PDGF-BB, PECAM-1, VEGF, TGFβ, IDO-1, IL-10, IL-1β, caspase-1, IL-17, IL-23, IL-23R IL-33, IL-12 p70, TRAIL, FOX01, Bcl-2, CXCL12 (SDF-1), CCL19, CCL21 analyzed in triplicate.
Secondary outcomes: periodontal probing depth, periodontal attachment level, bleeding on probing, visible plaque and gingival bleeding.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Type 2 Diabetes Mellitus, Periodontal Diseases, Periodontitis, Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nonsurgical periodontal treatment
Arm Type
Experimental
Arm Description
Nonsurgical periodontal treatment will be conducted following a full-mouth approach; no antibiotics or chemical plaque control will be provided.
Intervention Type
Procedure
Intervention Name(s)
Nonsurgical periodontal treatment
Intervention Description
All patients with GCP will receive full-mouth scaling and root planning under local analgesia in one session. Hopeless teeth will be treated similarly and extracted after de 30 days visit. Oral hygiene instructions will be given as needed.
Supragingival scaling Periodontally healthy subjects will receive supra-gingival scaling and polishing in one appointment as needed. Oral hygiene instructions will be given as needed.
Primary Outcome Measure Information:
Title
Change from baseline in cellular measures
Description
Cellular measures: Blood PBMCs- counts of myeloid DC (BDCA-1+CD19-), Plasmacytoid DC (cd123+cd303+) NK (CD56+CD16+), Th17, Treg (CD25+, CD39,CD73,CD127, cd152)
Time Frame
24 hours, 30 days and 3 months after treatment.
Title
Change from baseline in molecular measures
Description
Molecular measures: (Serum/crevicular fluid/ saliva): Anti-mfa-1 IgG (ELISA), Levels of IDO-1, TGFβ, TNFα, IL-1β, IL-6, IL-2, IL-10, IL-17, IL-23, IFNγ, CXCL12 (SDF1) by Multiplexing Luminex immunoassay [MAGPIX®]), performed in triplicate
Time Frame
24 hours, 30 days and 3 months after treatment.
Title
Change from baseline in the expression on mDCs
Description
Expression on mDCs by custom qrt-PCR array (One step-fast cycle Taqman®, life technologiesTM of: angiopoietin-2, follistatin, GM-CSF, G-CSF, HGF, IL8, IL-6, leptin, PDGF-BB, PECAM-1, VEGF, TGFβ, IDO-1, IL-10, IL-1β, caspase-1, IL-17, IL-23, IL-23R IL-33, IL-12 p70, TRAIL, FOX01, Bcl-2, CXCL12 (SDF-1), CCL19, CCL21 analyzed in triplicate.
Time Frame
24 hours, 30 days and 3 months after treatment.
Secondary Outcome Measure Information:
Title
periodontal probing depth, periodontal attachment level, bleeding on probing, visible plaque and gingival bleeding.
Time Frame
Baseline, 30 days and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects aged between 35 and 65 years
Subject diagnosed with T2DM (HbA1C ≥6.5), prediabetic (HbA1C ≥5.7 and ≤6.4) and non-diabetic (HbA1C ≤5.6) according to American Diabetes Association, 2013.
Subjects with GCP (PPD ≥5 mm in ≥10 teeth and BOP in ≥30% of sites) and without GCP (PPD ≤4mm and BOP in <30% sites)
Non-smokers or former smokers ≥5 years after quitting
Exclusion Criteria:
Pregnant or lactating women
Subjects taking medications known to affect the periodontium including phenytoin, cyclosporine
Subjects with immunosuppressive conditions or diseases including HIV infection or Hepatitis (B, C).
Subjects who require antibiotic prophylaxis for dental procedures.
Subjects who have taken antibiotics in the last 6 months
Subjects taking daily NSAIDS or on steroidal anti- inflammatory medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Romito, PhD
Organizational Affiliation
Professor and chair
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariana Rabelo, MSc
Organizational Affiliation
Post graduate student
Official's Role
Study Chair
Facility Information:
Facility Name
University of Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05508-900
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis
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