今天是:2020-08-03 星期一

口腔微生态与牙周稳态维持与重塑的机制
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注册号:

Registration number:

ChiCTR2000034447 

最近更新日期:

Date of Last Refreshed on:

2020-07-05 

注册时间:

Date of Registration:

2020-07-05 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

口腔微生态与牙周稳态维持与重塑的机制 

Public title:

Mechanisms of oral microecology in the regulation of maintenance and remodeling of periodontal homeostasis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

口腔微生态与牙周稳态维持与重塑的机制 

Scientific title:

Mechanisms of oral microecology in the regulation of maintenance and remodeling of periodontal homeostasis 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

苏志飞 

研究负责人:

李继遥 

Applicant:

Zhifei Su 

Study leader:

Jiyao Li 

申请注册联系人电话:

Applicant telephone:

+86 18200288067 

研究负责人电话:

Study leader's telephone:

+86 13628069354 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

1343475536@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jiyaoliscu@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

四川省成都市武侯区人民南路三段14号 

研究负责人通讯地址:

四川省成都市武侯区人民南路三段14号 

Applicant address:

14 Third Section Of Renmin Road South, Chengdu, Sichuan, China 

Study leader's address:

14 Third Section Of Renmin Road South, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

四川大学华西口腔医学院 

Applicant's institution:

West China College of Stomatology, Sichuan University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

WCHSIRB-D-2019-185 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

四川大学华西口腔医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of West China College of Stomatology, Sichuan University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-07 

伦理委员会联系人:

李伟 

Contact Name of the ethic committee:

Wei Li 

伦理委员会联系地址:

四川省成都市武侯区人民南路14号 

Contact Address of the ethic committee:

14 Third Section Of Renmin Road South, Chengdu, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

四川大学华西口腔医学院 

Primary sponsor:

West China College of Stomatology, Sichuan University 

研究实施负责(组长)单位地址:

四川省成都市武侯区人民南路三段14号 

Primary sponsor's address:

14 Third Section Of Renmin Road South, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西口腔医院

具体地址:

四川省成都市武侯区人民南路三段14号

Institution
hospital:

West China College of Stomatology, Sichuan University

Address:

14 Third Section Of Renmin Road South

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

牙周炎 

Target disease:

periodontitis 

研究疾病代码:

 

Target disease code:

 

研究类型:

基础科学研究 

Study type:

Basic Science 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本课题针对维持牙周稳态的微生物组、相关信号通路及关键分子机制不清楚;导致牙周稳态失衡的核心微生物等生态因子及内外环境因素不确定;重塑牙周稳态的调控靶点和关键路径不明确等科学问题,以牙周疾病新分类为基础,采用新一代测序和组学技术,结合动物 模型与体外实验,开展系列研究:1以特定状态牙周健康模型为对象,研究维持牙周稳态的微生物组与关键分子,探寻其分子机制。2以典型牙周疾病为对象,研究牙周稳态失衡时核心微生物与功能,阐明口腔微生态失衡介导牙周组织破坏的分子机制与关键节点。3基于前述研究获得的微生物群落、功能基因和代谢产物,探寻重塑牙周稳态的关键通路与机制。本课题系统深入的工作,将为牙周健康维持和牙周疾病防治提供新理论、新思路、新靶点;为“牙周稳态的维持与重塑机制”项目研究提供微生态支撑。 

Objectives of Study:

Human microbiomics provides many new practicable ideas and technologies to investigate the functions and mechanisms of microbial communities in the maintenance and remodeling of periodontal homeostasis. However, the key microbiota and its related signaling pathways and molecular mechanisms which maintain the periodontal homeostasis are not known. The core microbiome, host environmental factors and how they cause the periodontal dysbiosis are not clear. Moreover, the regulation targets and key pathways of therapeutic strategy, such as non-surgical treatment and drug treatment, to remodel periodontal homeostasis are not determined. To address these key scientific questions, we will employ the new generations of DNA sequencing and multi-omics techniques, different microbial and cell models in vitro, SPF and GF mouse models, cross-sectional and longitudinal study to investigate the mechanisms between oral microbiota and periodontal homeostasis maintenance and remodeling based on the new classification of periodontal diseases. In this project, we will 1identify the key microbiota and its molecular mechanisms to maintain periodontal homeostasis according to the health periodontal models, including health gingiva and stable periodontitis populations, based on Immunohistochemistry, 16S rDNA sequencing, metagenomics, transcriptome, proteome and metabolome. GF and SPF mouse will be subjected to confirm the microbiota and molecular pathways; 2 construct typical periodontal disease models, including periodontitis and periodontal-endodontic combined disease, to identify the core microbes and their biofunctions, and to investigate molecular mechanisms that how the core microbes cause the periodontal dysbiosis by using different omics techniques, such microbiomics, transcriptome, proteome and metabolome. The key functional or virulent genes will be knockout to found out the essential functional genes, protein and metabolites. Then the periodontitis and periodontal-endodontic combined disease SPF mouse will be applied to confirm capabilities of core microbiota, essential functional genes and metabolites; 3 decipher the key pathways and molecular mechanisms that how the periodontal non-surgical treatment and drug treatment remodel the periodontal homeostasis by constructing SPF mouse models and population disease models based on the periodontitis and periodontal-endodontic combined diseases. Our project aims to provide novel theories, new ideas and models for the maintenance of periodontal health and prevention of periodontal diseases. Moreover, the characters of oral microbiota and molecular mechanisms from our project is the foundation and support of the whole major project mechanism of maintenance and remodeling of periodontal homeostasis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1. 18~50岁; 2. 牙周炎或者牙周健康人群 3. 大于20颗天然牙(不包括第三磨牙) 

Inclusion criteria

1. Patients aged 18-50 years; 2. People with periodontitis or periodontal health; 3. Patients with more than 20 natural teeth (excluding the third molar). 

排除标准:

1. 身体指数或重要生命体征超出正常范围(如BMI≥35或≤18,脉搏>100/分等); 2. 高血压、糖尿病以及肝肾疾病等系统性疾病史; 3. 近三个月全身使用抗生素,一周内口腔局部使用抗生素,六个月内曾行牙周治疗; 4. 怀孕、或哺乳期; 5. 可影响牙周炎临床指征的持续性药物治疗 

Exclusion criteria:

1. The objects whose body index or vital signs are beyond the normal range (such as BMI >=35 or <=18, pulse > 100 / score); 2. Patients with a history of systemic diseases such as hypertension, diabetes and liver and kidney diseases; 3. The patients who had been treated with antibiotics in the whole body in the past three months, oral local antibiotics in one week and periodontal treatment in six months; 4. Pregnant or lactating objects; 5. Subjects receiving continuous drug therapy that can affect the clinical indications of periodontitis. 

研究实施时间:

Study execute time:

From2020-07-01To 2024-12-31 

征募观察对象时间:

Recruiting time:

From2020-07-01To 2024-12-31 

干预措施:

Interventions:

组别:

所有纳入人群

样本量:

600

Group:

all included people

Sample size:

干预措施:

唾液收集

干预措施代码:

Intervention:

Saliva collection

Intervention code:

组别:

所有纳入人群

样本量:

600

Group:

all included people

Sample size:

干预措施:

龈沟液收集

干预措施代码:

Intervention:

Gingival crevicular fluid collection

Intervention code:

组别:

所有纳入人群

样本量:

600

Group:

all included people

Sample size:

干预措施:

菌斑收集

干预措施代码:

Intervention:

Plaque collection

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西口腔医院 

单位级别:

三级甲等 

Institution
hospital:

West China College of Stomatology, Sichuan University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

微生物组学

指标类型:

主要指标 

Outcome:

Microbiology

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

牙周炎临床指标

指标类型:

主要指标 

Outcome:

Clinical index of periodontitis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

唾液

组织:

Sample Name:

saliva

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

龈沟液

组织:

Sample Name:

Gingival crevicular fluid

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

菌斑

组织:

Sample Name:

Plaque

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

Randomization Procedure (please state who generates the random number sequence and by what method):

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

试验完成后1年内,以发表文章的形式公开原始数据。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The original data will be published in the form of a published article within 1 year after the completion of the experiment

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

病历记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Case record

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-07-05
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