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

NCT02172716 | Completed DMC

• 1 other identifier: 26793214.9.0000.0075
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Type 2 Diabetes Mellitus; Periodontal Diseases; Periodontitis; Chronic Periodontitis

Outcome Measures

Primary Outcomes (3)

• 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)

  24 hours, 30 days and 3 months after treatment.

• 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

  24 hours, 30 days and 3 months after treatment.

• 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.

  24 hours, 30 days and 3 months after treatment.

Secondary Outcomes (1)

• periodontal probing depth, periodontal attachment level, bleeding on probing, visible plaque and gingival bleeding.

  Baseline, 30 days and 3 months

Study Arms (1)

Nonsurgical periodontal treatment

EXPERIMENTAL

Nonsurgical periodontal treatment will be conducted following a full-mouth approach; no antibiotics or chemical plaque control will be provided.

Procedure: Nonsurgical periodontal treatment

Interventions

Nonsurgical periodontal treatment PROCEDURE

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.

Nonsurgical periodontal treatment

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Augusta University: collaborator

Study Sites (1)

University of Sao Paulo

São Paulo, São Paulo, 05508-900, Brazil

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Periodontal Diseases; Periodontitis; Chronic Periodontitis

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Romito, PhD

  Professor and chair

  PRINCIPAL INVESTIGATOR

• Mariana Rabelo, MSc

  Post graduate student

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Study Record Dates

• First Submitted: June 17, 2014
• First Posted: June 24, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

BR (1)