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3D printing modified individual tooth tray for impression taking for multi-unit preparatioins in fixed restoration
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注册号:

Registration number:

ChiCTR1900027319 

最近更新日期:

Date of Last Refreshed on:

2019-11-08 

注册时间:

Date of Registration:

2019-11-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

3D打印改良个齿托盘在多单位冠桥修复印模制取中的应用 

Public title:

3D printing modified individual tooth tray for impression taking for multi-unit preparatioins in fixed restoration 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

3D打印改良个齿托盘在多单位冠桥修复印模制取中的应用 

Scientific title:

3D printing modified individual tooth tray for impression taking for multi-unit preparatioins in fixed restoration 

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:

徐啸翔 

研究负责人:

徐啸翔 

Applicant:

Xiaoxiang Xu 

Study leader:

Xiaoxiang Xu 

申请注册联系人电话:

Applicant telephone:

+86 13718906151 

研究负责人电话:

Study leader's telephone:

+86 13718906151 

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:

xxx19860816@163.com 

研究负责人电子邮件:

Study leader's E-mail:

xxx19860816@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:

北京市海淀区中关村南大街22号 

研究负责人通讯地址:

北京市海淀区中关村南大街22号 

Applicant address:

22 South Zhong-Guan-Cun Street, Haidian District, Beijing, China 

Study leader's address:

22 South Zhong-Guan-Cun Street, Haidian District, Beijing, 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:

北京大学口腔医院 

Applicant's institution:

Peking University School and Hospital of Stomatology 

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:

PKUSSIRB-201949143 

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:

北京大学口腔医院生物医学伦理委员会 

Name of the ethic committee:

Biomedical Ethics Committee of Peking University School and Hospital of Stomatology 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-11-04 

伦理委员会联系人:

贾效伟 

Contact Name of the ethic committee:

Xiaowei Jia 

伦理委员会联系地址:

北京市海淀区中关村南大街22号 

Contact Address of the ethic committee:

22 South Zhong-Guan-Cun Street, Haidian District, Beijing, 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:

北京大学口腔医院 

Primary sponsor:

Peking University School and Hospital of Stomatology 

研究实施负责(组长)单位地址:

北京市海淀区中关村南大街22号 

Primary sponsor's address:

22 South Zhong-Guan-Cun Street, Haidian District, Beijing, 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学口腔医院

具体地址:

海淀区中关村南大街22号

Institution
hospital:

Peking University School and Hospital of Stomatology

Address:

22 South Zhong-Guan-Cun Street, Haidian District

经费或物资来源:

北京大学口腔医院临床新技术新疗法项目 

Source(s) of funding:

Program for New Clinical Techniques and Therapies of Peking University School and Hospital of Stomatology 

研究疾病:

牙体缺损、牙列缺损 

Target disease:

tooth defect, dentition defect 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

与传统成品托盘一步法比较,评估改良个齿托盘法在多单位冠桥预备体印模制取中的临床应用效果。 

Objectives of Study:

To evaluate the clincial effects of using modified individual tooth tray for impression taking for multi-unit preparations in fixed restoration, compared with traditioinal stock tray one step method. 

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:

需要进行单颌多单位冠桥修复(8-14单位)的病例,身体健康,依从性良好。 

Inclusion criteria

Patients who need multi-unit fixed restorations (8-14 units) in single jaw, in good health and with good compliance. 

排除标准:

有预备体为活髓且非常敏感;对印模制取过程容易有恶心等不适反应;有系统性疾病身体耐受条件差;不愿配合试验。 

Exclusion criteria:

Prepared tooth is vital and sensitive, uncomfortalbe for impression taking, in poor health, or unwilling to cooperate with the test. 

研究实施时间:

Study execute time:

From2019-11-04To 2020-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

5

Group:

Case series

Sample size:

干预措施:

分别使用成品托盘一步法及改良个齿托盘法制取印模

干预措施代码:

Intervention:

Making impression with stock tray one step method and modified individual tooth tray method

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京市 

市(区县):

海淀区 

Country:

China 

Province:

Beijing 

City:

Haidian District 

单位(医院):

北京大学口腔医院 

单位级别:

三级甲等 

Institution
hospital:

Peking University School and Hospital of Stomatology  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

印模制取过程满意度评分

指标类型:

主要指标 

Outcome:

Satisfaction scoring for impression taking process

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

印模制取结果满意度评分

指标类型:

主要指标 

Outcome:

Satisfaction scoring for impression effect

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

印模制取时间

指标类型:

主要指标 

Outcome:

Time for impression taking

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

印模制取次数

指标类型:

主要指标 

Outcome:

Times of impression taking

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

印模效果评分

指标类型:

主要指标 

Outcome:

Scores for impression effect

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:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

正在进行

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):

不随机

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

Non-randomization

盲法:

所有数据采用独立样本t检验进行统计分析,P<0.05认为差异有统计学意义。

Blinding:

Blind method for evaluation.

原始数据公开时间:

The time of sharing IPD:

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):

发表文章

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

Publish research article

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:

所有数据由一名研究者汇总,及时、完整、正确、清晰地记录原始数据,并进行电子录入。原始数据和电子数据分别妥善保存。

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

All data will be collected and recorded timely and precisely by one researcher. The electronic record will also be completed. Raw data and electronic data will be saved properly.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-11-08
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