今天是:2020-10-31 星期六

下载XML文档

注册号:

Registration number:

ChiCTR-IOR-16008194 

最近更新日期:

Date of Last Refreshed on:

2016-03-31 

注册时间:

Date of Registration:

2016-03-31 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

 

Public title:

Probiotic Bacteria for Oral Health 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

 

Scientific title:

Probiotic modulation of oral ecology. 

研究课题代号(代码):

Study subject ID:

UW 16-077 

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:

 

研究负责人:

 

Applicant:

Aneesha Acharya 

Study leader:

Nikos Mattheos 

申请注册联系人电话:

Applicant telephone:

+85251307181 

研究负责人电话:

Study leader's telephone:

+852 2859 0526 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

+852 2858 6114 

申请注册联系人电子邮件:

Applicant E-mail:

aneesha.a2@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

nikos@mattheos.net 

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:

 

研究负责人通讯地址:

 

Applicant address:

Oral Rehabilitation Department (Implant Dentistry), The Prince Philip Dental Hospital, 34- Hospital Road, Hong Kong  

Study leader's address:

Oral Rehabilitation Department (Implant Dentistry), The Prince Philip Dental Hospital, 34-Hospital Road, Hong Kong 

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:

 

Applicant's institution:

Faculty of Dentistry, University of Hong Kong 

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:

UW 16-077 

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:

 

Name of the ethic committee:

Institutional review Board of the University of Hong Kong Hospital Authority HOng Kong West Cluster (HKWC-HKU Cluster REC/IRB) 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-02-18 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

 

Primary sponsor:

Nikos Mattheos 

研究实施负责(组长)单位地址:

 

Primary sponsor's address:

Oral Rehabilitation Department (Implant Dentistry), The Prince Philip Dental Hospital, 34- Hospital Road, Hong Kong  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

India

Province:

Maharashtra

City:

Pune

单位(医院):

具体地址:

Institution
hospital:

MA Rangoonwala College of Dental Sciences and Research

Address:

MA Rangoonwala College of Dental Sciences and Research, Pune, Camp

经费或物资来源:

 

Source(s) of funding:

University Funding 

研究疾病:

 

Target disease:

Periodontal Disease, Periimplant Disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

 

Objectives of Study:

To investigate if a probiotic supplement provided during oral biofilm development may modulate the establishing microbial community in healthy and dysbiotic states intra-orally. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

Probiotic supplement containing Lactobacillus strains; DSM 17938 and ATCC PTA 5289 (ProdentisTM , BioGaia, Lund Sweden) is regulated as food supplement in Hong Kong  

研究设计:

随机交叉对照 

Study design:

Cross-over 

纳入标准:

 

Inclusion criteria

Systemically healthy, non-smoker adult subjects (30-65 years) will recruited into 3 groups as follows: Group1: Diagnosed as having generalized chronic periodontitis (CP); Group2: Diagnosed as periodontally healthy controls (H); Group3: Partially edentulous and have received implant therapy, with periimplant health and ready to receive a definitive prosthesis. (I) 

排除标准:

 

Exclusion criteria:

1. A recent history of trauma or tooth extractions; 2. Pregnant or lactating females; 3. Diagnosis of periimplantitis (PD >=5mm with signs of supporting bone loss); 4. Implant sites treated with augmentation procedures; 5. Subjects who underwent antibiotic therapy within past 3 months; 6. Radiation therapy in the head and neck area, HIV, Tuberculosis, hepatitis or other infectious diseases or uncontrolled diabetes, ischaemic heart disease, thyroid disorders or psychological problems. 

研究实施时间:

Study execute time:

From2016-05-01To 2017-11-01 

征募观察对象时间:

Recruiting time:

From2016-05-01To 2016-11-01 

干预措施:

Interventions:

组别:

样本量:

14

Group:

1/2/3

Sample size:

干预措施:

干预措施代码:

Intervention:

Crossover- Active - Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

 

省(直辖市):

 

市(区县):

 

Country:

China 

Province:

SAR Hong Kong 

City:

Hong Kong 

单位(医院):

 

单位级别:

 

Institution
hospital:

Faculty of Dentistry, University of Hong Kong  

Level of the institution:

University 

国家:

 

省(直辖市):

 

市(区县):

 

Country:

India 

Province:

Maharashtra 

City:

Pune 

单位(医院):

 

单位级别:

 

Institution
hospital:

M A Rangoonwala College of Dental Sciences and Research  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标 

Outcome:

Microbiome Analysis

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

主要指标 

Outcome:

Microbiome Analysis

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:

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:

组织:

Sample Name:

Plaque

Tissue:

Teeth

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:

组织:

Sample Name:

Plaque

Tissue:

Dental Implant

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 30 years
最大 Max age 65 years

性别:

男性

Gender:

Male

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):

Aneesha Acharya (AA) will generate computerized random number sequence using R programming packages.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

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

Anonymised electronic dataset form will be prepared (also containing supplementary protocol, blank CRFs, dataset specifications). Data requests will be reviewed by Principal Investigator.

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:

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

Raw data would be digitally formatted and stored (input into SPSS/Excel spread sheets) followed by cross checking for anomalies. PI and his team will be responsible for safekeeping the data. Any written materials will be locked up. All information will be destroyed six months after all relevant research reports have been published.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-03-31
返回列表