Trial record 3 of 5 for:    periodontal dendritic cells

Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Sao Paulo
Sponsor:
Collaborator:
Georgia Regents University
Information provided by (Responsible Party):
Giuseppe Alexandre Romito, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02172716
First received: June 17, 2014
Last updated: June 22, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Type 2
Type 2 Diabetes Mellitus
Periodontal Diseases
Periodontitis
Chronic Periodontitis
Procedure: Nonsurgical periodontal treatment

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Change from baseline in cellular measures [ Time Frame: 24 hours, 30 days and 3 months after treatment. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours, 30 days and 3 months after treatment. ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 24 hours, 30 days and 3 months after treatment. ] [ Designated as safety issue: Yes ]
    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. [ Time Frame: Baseline, 30 days and 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nonsurgical periodontal treatment
Nonsurgical periodontal treatment will be conducted following a full-mouth approach; no antibiotics or chemical plaque control will be provided.
Procedure: Nonsurgical periodontal treatment

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.


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.
  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects aged between 35 and 65 years
  2. 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.
  3. 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)
  4. Non-smokers or former smokers ≥5 years after quitting

Exclusion Criteria:

  1. Pregnant or lactating women
  2. Subjects taking medications known to affect the periodontium including phenytoin, cyclosporine
  3. Subjects with immunosuppressive conditions or diseases including HIV infection or Hepatitis (B, C).
  4. Subjects who require antibiotic prophylaxis for dental procedures.
  5. Subjects who have taken antibiotics in the last 6 months
  6. Subjects taking daily NSAIDS or on steroidal anti- inflammatory medications
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02172716

Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 05508-900
Contact: Mariana Rabelo, MSc    55 11 998812141    mariana.rabelo@usp.br   
Principal Investigator: Giuseppe Romito, PhD, chair         
Sponsors and Collaborators
University of Sao Paulo
Georgia Regents University
Investigators
Principal Investigator: Giuseppe Romito, PhD Professor and chair
Study Chair: Mariana Rabelo, MSc Post graduate student
  More Information

No publications provided

Responsible Party: Giuseppe Alexandre Romito, Professor and Chair, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02172716     History of Changes
Other Study ID Numbers: 26793214.9.0000.0075
Study First Received: June 17, 2014
Last Updated: June 22, 2014
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health
Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Periodontitis
Chronic Periodontitis
Periodontal Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on September 16, 2014