Evaluation of the Effects of Initial Macrophage and Th17 Cell Activities on the Healing Following Periodontal Phase I Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Change in Bleeding on probing (BoP)
研究概览
简要总结
Periodontitis is an inflammatory disease with an infectious character, where, as the result of the host response to a dysbiotic microflora, attachment and bone loss occur. The host response and the healing period following the treatment differs among individuals, but the reason behind is not fully understood. The macrophages and T cells play an important role in the immune response and in the pathogenesis of periodontal diseases, but their role in the healing following periodontal therapy is not known. In this study, we aim to reveal the effects of initial macrophage and T cell activities in the gingival tissue on the differences of the response to phase I periodontal treatment.
42 individuals will be included in the study. Granulation tissue samples will be collected from two separate deep pockets of each individual, initially. At the same session, full-mouth scaling and root debridement will be conducted. Saliva, subgingival biofilm and gingival crevicular fluid (GCF) samples will also be collected, initially, and at the 2nd, 6th, 12th and 24th weeks. At the same appointments, periodontal parameters will be recorded. When the clinical procedures are concluded, the samples will be sent to Turku University with dry ice. Tissue and GCF concentrations of related cytokines will be analyzed with Luminex. The density of macrophage types will be defined by immunoblot analysis of related markers. Macrophage subpopulations in tissues will be specified by proteomics. Likewise, quantities of periodontal pathogens will be evaluated with DNA isolation and next generation sequencing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe periodontitis
- •having at least two pockets ≥ 6 mm
- •systemic healthy
排除标准
- •received periodontal treatment prior to study
- •received antibiotic or antiinflammatory drugs in the last 6 months
- •pregnant or in lactation
结局指标
主要结局
Change in Bleeding on probing (BoP)
时间窗: baseline, 2nd, 6th, 12th and 24th weeks following therapy
visual inspection, dichotomous; full-mouth, 6 sites per tooth; change in positive sites %
Change in Probable pocket depth (PPD)
时间窗: baseline, 2nd, 6th, 12th and 24th weeks following therapy
distance between the gingival margin and pocket base (mm); full-mouth scores, 6 sites per tooth
Baseline Th17-pathway related cytokine concentrations in granulation tissue samples
时间窗: Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months
two pockets (≥6mm; BoP+) of each individual; Luminex: Interleukin (IL)-1β, -4, -6, -10, -17A, -17F, -21, -22, -23, -25, -31, -33, interferon (IFN)-γ, soluble cluster of differentiation 40 ligand (sCD-40L), tumor necrosis factor (TNF)-ɑ concentrations (pg/mL); each will be correlated with the change in probable pocket depth and bleeding on probing scores
Baseline density of macrophage types in granulation tissue samples
时间窗: Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months
two pockets (≥6mm; BoP+) from each individual; Immunoblot analysis: cluster of differentiation(CD)68 and CD163; cell number / optic field (cells/mm2); each will be correlated with the change in probable pocket depth and bleeding on probing scores
Baseline macrophage related cytokine concentrations in granulation tissue samples
时间窗: Samples will be obtained during the intervention and will be kept in -80oC until immunohistochemical analysis which will be carried out through study completion, 6-9 months
two pockets (≥6mm; BoP+) of each individual; Luminex: monocyte chemoattractant protein (MCP)-1, -2, -3, -4; macrophage derived chemokine (MDC); macrophage inhibitory factor (MIF), monokine induced by gamma interferon (MIG), macrophage inflammatory protein (MIP)-1α, interferon γ-induced protein (IP)-10, CD163, TWEAK, BAFF concentrations (pg/mL); each will be correlated with the change in probable pocket depth and bleeding on probing scores
次要结局
- Change in macrophage and Th17-pathway related cytokine concentrations in saliva(baseline, 2nd, 6th, 12th and 24th weeks following therapy; immunohistochemical analysis will be carried out through study completion, 6-9 months)
- Change in macrophage and Th17-pathway related cytokine concentrations in gingival crevicular fluid (GCF)(baseline, 2nd, 6th, 12th and 24th weeks following therapy; immunohistochemical analysis will be carried out when through study completion, 6-9 months)
- Change in neutrophil-associated cytokines in and oral rinse(baseline, 6th, 12th and 24th weeks following therapy)
- Change in neutrophil-associated cytokines in saliva(baseline, 6th, 12th and 24th weeks following therapy)
- Change in clinical attachment level (CAL)(baseline, 2nd, 6th, 12th and 24th weeks following therapy)
- Change in biofilm microbiota(baseline, 2nd, 6th, 12th and 24th weeks following therapy; microbiological analysis will be carried out through clinical phase completion, 6-9 months)
- Change in plaque index(baseline, 2nd, 6th, 12th and 24th weeks following therapy)
- active MMP-8 point-of-care test results in oral rinse(baseline, 6th, 12th and 24th weeks following therapy)
研究者
Mustafa YILMAZ
Asst Prof
Biruni University