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CAD/CAM导板辅助下种植手术效果的多中心、前瞻性临床探究
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注册号:

Registration number:

ChiCTR1800014441 

最近更新日期:

Date of Last Refreshed on:

2018-01-13 

注册时间:

Date of Registration:

2018-01-13 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

CAD/CAM导板辅助下种植手术效果的多中心、前瞻性临床探究 

Public title:

A multicenter, prospective clinical study of evaluate the effect of dental implant surgery assist by CAD/CAM guiding templates 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

CAD/CAM导板辅助下种植手术效果的多中心、前瞻性临床探究 

Scientific title:

A multicenter, prospective clinical study of evaluate the effect of dental implant surgery assist by CAD/CAM guiding templates 

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:

胡琛 

研究负责人:

邵龙泉 

Applicant:

Hu Chen 

Study leader:

Shao Longquan 

申请注册联系人电话:

Applicant telephone:

+86 13631351523 

研究负责人电话:

Study leader's telephone:

+86 15989283921 

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:

280017409@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

shaolongquan@smu.edu.cn 

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:

广东省广州市广州大道北1838号南方医院口腔科 

研究负责人通讯地址:

广东省广州市广州大道北1838号南方医院口腔科 

Applicant address:

1838 Guangzhou Road North, Guangzhou, Guangdong, China 

Study leader's address:

1838 Guangzhou Road North, Guangzhou, Guangdong, 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:

南方医科大学南方医院 

Applicant's institution:

Nanfang Hospital, South Medical 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:

NFEC-2017-072 

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:

南方医科大学南方医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Nanfang Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

宿爱山 

Contact Name of the ethic committee:

Su Aishan 

伦理委员会联系地址:

广东省广州市广州大道北1838号南方医院 

Contact Address of the ethic committee:

1838 Guangzhou Road North, Guangzhou, Guangdong, 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:

南方医科大学南方医院 

Primary sponsor:

Nanfang Hospital,South Medical University 

研究实施负责(组长)单位地址:

广东省广州市广州大道北1838号南方医院 

Primary sponsor's address:

1838 Guangzhou Road North, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医院

具体地址:

广东省广州市广州大道北1838号南方医院

Institution
hospital:

Nanfang Hospital

Address:

1838 Guangzhou Road North, Guangzhou, Guangdong, China

经费或物资来源:

南方医科大学临床研究启动计划 

Source(s) of funding:

Clinial Research Program of Nanfang Hospital,South Medical University 

研究疾病:

牙列缺损和牙列缺失 

Target disease:

partial edentulous or edentulous jaw 

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:

I期临床试验 

Study phase:

I (Phase I study) 

研究目的:

1、评价不同制造方法的种植导板的手术精度。 2、全面系统分析影响手术精度和治疗效果的因素,并为临床设计及风险规避提供参考。? 

Objectives of Study:

1. To evaluate the accuracy of dental implant surgery assist by different guiding templates; 2. To analyze the causes of the accuracy and the effect in dental implant surgeries fully and systematically. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

1、患者知情同意;2、存在牙缺失且有种植需要,符合牙种植体修复术指征;3、能够按时复诊;4、能在术前术后接受放射学设备扫描 

Inclusion criteria

1. patients have signed informed consent; 2. dentition defect or missing which meet the indication of dental implants treatment; 3. can follow up the study on time; 4. can accept the radiology equipment before and after the operation. 

排除标准:

1、患者有全身系统性疾病,健康状况不允许承受外科手术;2、存在不良咬合习惯者;3、患者有酒精、药物滥用情况;4、种植部位存在病损,如:肿瘤;5、研究者认为不适宜参加此试验者。 

Exclusion criteria:

1. patients have systemic disease, their health condition are not allowed to accept surgery; 2. have poor bite habits; 3. alcohol or drug addiction; 4. implant areas exist lesion, such as tumor,etc; 5. any other condition which is considered as not suit for the study. 

研究实施时间:

Study execute time:

From2018-01-30To 2021-10-01 

干预措施:

Interventions:

组别:

数控切割组

样本量:

42

Group:

CAD/CAM

Sample size:

干预措施:

数控切割制造种植导板

干预措施代码:

Intervention:

CAD/CAM

Intervention code:

组别:

3D打印组

样本量:

42

Group:

3D Printing Group

Sample size:

干预措施:

3D打印种植导板

干预措施代码:

Intervention:

3D Printing

Intervention code:

组别:

传统方法制作组

样本量:

42

Group:

Traditional Production Group

Sample size:

干预措施:

传统方法制作种植导板

干预措施代码:

Intervention:

Traditional Production

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医院 

单位级别:

三级甲等 

Institution
hospital:

Nanfang Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

手术精度

指标类型:

主要指标 

Outcome:

accuracy of surgery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

制作精度

指标类型:

次要指标 

Outcome:

accracy of production

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后成功率

指标类型:

次要指标 

Outcome:

success rate of the surgery

Type:

Secondary 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:

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 18 years
最大 Max age 100 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):

本研究采用SAS软件以中心分层的分段随机化方法,产生受试者的随机分组码,根据患者的入选顺序给予相应编号的治疗方法。

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

The random numbers are generated with stratified blocked randomization way by SAS software. Patients are teated with the corresponding intervention code.

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:

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):

项目组根据研究进程择期选择具体方式公开原始数据

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

According to the progress of the research, raw research data should be made freely available to all researchers in specific ways

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:

数据记录在电子CRF系统,由专门的研究人员收集及管理数据。录入采用相应的数据库系统双人双机录入。

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

Data are recorded in CRF system. Date are collected and managed by one researcher. Input the data into corresponding database system by two special researchers with two computers respectively.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-01-13
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