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注册号:

Registration number:

ChiCTR-IOR-15006117 

最近更新日期:

Date of Last Refreshed on:

2015-03-20 

注册时间:

Date of Registration:

2015-03-20 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

 

Public title:

Treatment outcome of single-visit versus multiple-visit non-surgical endodontic therapy 

注册题目简写:

 

English Acronym:

Treatment outcome of single-visit versus multiple-visit non-surgical endodontic therapy 

研究课题的正式科学名称:

 

Scientific title:

Treatment outcome of single-visit versus multiple-visit non-surgical endodontic therapy 

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:

 

研究负责人:

 

Applicant:

Dr. Amy Wong 

Study leader:

Dr. Chu Chun Hung 

申请注册联系人电话:

Applicant telephone:

+852-94913698 

研究负责人电话:

Study leader's telephone:

+852-28590371 

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:

drawong@hku.hk 

研究负责人电子邮件:

Study leader's E-mail:

chchu@hku.hk 

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:

3/F, Dental Unit, Meng Wah Complex, The University of Hong Kong, Pokfulam Road, Hong Kong 

Study leader's address:

3B61, 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:

The 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 09-303 

伦理委员会批件附件:

Approved file of Ethical Committee:

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 (HKU/HA HKW IRB) 

伦理委员会批准日期:

Date of approved by ethic committee:

2009-07-22 

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:

Faculty of Dentistry, The University of Hong Kong 

研究实施负责(组长)单位地址:

 

Primary sponsor's address:

3B61, 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:

经费或物资来源:

 

Source(s) of funding:

Faculty of Dentistry, The University of Hong Kong 

研究疾病:

 

Target disease:

Pulpal 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:

This randomized clinical trial aims to compare the treatment outcome of single-visit and multiple-visit non-surgical endodontic treatment 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

 

Inclusion criteria

The study was approved by the Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU UW 09 - 303) in Hong Kong. Chinese patients aged 18 or above who were generally healthy and required primary endodontic treatment via the HKU Health Service Dental Clinic were invited to participate in the study. The protocol of the study was explained to the participants, and consent was sought. 

排除标准:

 

Exclusion criteria:

Teeth with pulpotomy were not accepted, and at least half of the coronal structure had to be present. Patients who had severe acute pulpitis with facial swelling or systemic infection, severe systemic disease, increased stress on the temporomandibular joint musculature, or increased psychological stress were excluded from this study. 

研究实施时间:

Study execute time:

From2010-09-01To  

征募观察对象时间:

Recruiting time:

From2010-09-01To  

干预措施:

Interventions:

组别:

样本量:

256

Group:

Two groups

Sample size:

干预措施:

干预措施代码:

Intervention:

single-visit or multiple-visit endodontic treatment

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:

Hong Kong SAR 

City:

 

单位(医院):

 

单位级别:

 

Institution
hospital:

The University of Hong Kong  

Level of the institution:

University 

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标 

Outcome:

success or failure

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:

Tooth

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 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):

Randomly assigned

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):

是否共享原始数据:

IPD sharing

否No

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):

The University of Hong Kong

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:

The University of Hong Kong

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2015-03-20
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