Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis
Condition: Diabetes Mellitus, Type 2; Type 2 Diabetes Mellitus; Periodontal Diseases; Periodontitis; Chronic Periodontitis
MeSH terms: Periodontitis; Periodontal Diseases; Chronic Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Nonsurgical periodontal treatment
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment