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

NCT ID: NCT02172716

Last Updated: 2018-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-05-31

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nonsurgical periodontal treatment

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

Group Type: EXPERIMENTAL

Nonsurgical periodontal treatment

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Augusta University

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Alexandre Romito

Professor and Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Romito, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor and chair

Mariana Rabelo, MSc

Role: STUDY_CHAIR

Post graduate student

Locations

University of Sao Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

26793214.9.0000.0075

Identifier Type: -

Identifier Source: org_study_id