Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis
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.
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.
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