Disruption of Immune Homeostasis in Type 2 Diabetics With Generalized Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in cellular measures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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,
- •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
排除标准
- •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
研究组 & 干预措施
Nonsurgical periodontal treatment
Nonsurgical periodontal treatment will be conducted following a full-mouth approach; no antibiotics or chemical plaque control will be provided.
干预措施: Nonsurgical periodontal treatment (Procedure)
结局指标
主要结局
Change from baseline in cellular measures
时间窗: 24 hours, 30 days and 3 months after treatment.
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 the expression on mDCs
时间窗: 24 hours, 30 days and 3 months after treatment.
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.
Change from baseline in molecular measures
时间窗: 24 hours, 30 days and 3 months after treatment.
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
次要结局
- periodontal probing depth, periodontal attachment level, bleeding on probing, visible plaque and gingival bleeding.(Baseline, 30 days and 3 months)
研究者
Giuseppe Alexandre Romito
Professor and Chair
University of Sao Paulo