Metagenomic and Immune-inflammatory Analysis of Individuals With Generalized Aggressive Periodontitis and Their Descendants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 主要终点
- Change of the baseline plaque index on probing at 3 months
研究概览
简要总结
Generalized aggressive periodontitis (GAgP) is a multifactorial disease related to several aspects that influence its installation and progression. A constant microbial colonization, an altered inflammatory response, and a clear genetic factor are cited as possible factors associated with this pathology. Thus, aggressive periodontitis subjects could transmit for their descendants some genetical alterations, such as inflammatory response pattern associated with periodontal destruction and susceptibility to colonization by some pathogens, increasing the risk of develops this disease. This way, this project is aimed to evaluate the pattern of microbiological colonization and the inflammatory response pattern associated with it, comparing parents with generalized aggressive periodontitis and their children and periodontally healthy parents and their children. Thirty families will be selected and divided into two groups: Test group (n=15 families) families in which the parents (or at least one of them) present generalized aggressive periodontitis and one child (age ranging from 6-12 years old); Control group (n=15 families) families in which the parents (both of them) present periodontal healthy and one child (age ranging from 6-12 years old). The groups will be composed using a gender- and age-matched structure. The children will participate in a hygiene program and will be monitored for 3 months. All individuals (parents and children) will be clinically assessed for plaque and bleeding index, periodontal probing depth, clinical attachment level and gingival recession. During this period, samples of gingival crevicular fluid (GCF) and subgingival biofilm from periodontal pockets/sites from all subject (parents and children) will be collected. The GCF will be analyzed and the detection of interleukin (IL)-1β, IL-4, IL-6, IL-8, IL-10, IL-17, tumor necrosis factor (TNF)-α, and interferon (INF)-γ will be done using Luminex/MAGpix technology. In a subgingival biofilm, the DNA will be extracted and the microbiome and its functional characteristics will be evaluated by metagenomics and bioinformatics analysis. The data will be compared by Student's t-test, Mann-Whitney e Wilcoxon tests. The significance level for all analysis will be 5%.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •GAgP parents: i) less than 35 years old at the diagnosis; ii) at least 8 teeth with probing depth (PD) and clinical attachment level (CAL) > 5mm (with at least 2 sites with PD > 7mm) at diagnosis; iii) at least 20 teeth in the oral cavity; iv) good systemic health.
- •Health parents: i) Good systemic health; ii) at least 20 teeth in the oral cavity; iii) absence of periodontal pockets/gingival sulcus with PD > 4mm; iv) absence of proximal bone loss.
- •Children: i) to present parents respecting the inclusion criteria for periodontal health or GAgP; ii) 6 to 12 years of age at the beginning of study iii) good systemic health iv) presence of first molars and central incisors.
- •Exclusion Criteria
- •the use of antibiotics and anti-inflammatory medication 6 months prior to the study;
- •smoking habits
- •pregnancy or lactation.
排除标准
- 未提供
结局指标
主要结局
Change of the baseline plaque index on probing at 3 months
时间窗: Baseline and 3 months for each test
Reduction in the amount of plaque accumulation around the gingival marginal after the therapy.
次要结局
- Change of the baseline inflammatory markers levels in gingival crevicular fluid (pg/uL) at 3 months(Baseline and 3 months for each test)
- Change of the baseline bleeding on probing at 3 months(Baseline and 3 months for each test)
- Change in the microbial composition at 3 months(Baseline and 45 days for each test)
研究者
Renato Casarin
Professor Dr.
University of Campinas, Brazil