中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR1900026731
最近更新日期： Date of Last Refreshed on：	2019-10-20 10:34:07
注册时间： Date of Registration：	2019-10-20 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	该研究尚未获得伦理委员会批准。请于批准后才开始纳入参试者，并与我们联系上传批件。对比静态导板和动态导航系统在无牙颌患者种植术中精度的前瞻性随机对照多中心临床试验研究
Public title：	A prospective randomized controlled multicenter clinical trial to compare the accuracy of static guide plate and dynamic navigation system in edentulous patients
注册题目简写：
English Acronym：
研究课题的正式科学名称：	对比静态导板和动态导航系统在无牙颌患者种植术中精度的前瞻性随机对照多中心临床试验研究
Scientific title：	A prospective randomized controlled multicenter clinical trial to compare the accuracy of static guide plate and dynamic navigation system in edentulous patients
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：	陶宝鑫	研究负责人：	吴轶群
Applicant：	Tao Baoxin	Study leader：	Wu Yiqun
申请注册联系人电话： Applicant telephone：	+86 15754307895	研究负责人电话： Study leader's telephone：	+86 13916892306
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：	taobx3314@outlook.com	研究负责人电子邮件： Study leader's E-mail：	yiqunwu@outlook.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：	上海市黄浦区制造局路639号	研究负责人通讯地址：	上海市黄浦区制造局路639号
Applicant address：	639 Zhizaoju Road, Huangpu District, Shanghai, China	Study leader's address：	639 Zhizaoju Road, Huangpu District, Shanghai, 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：	上海交通大学医学院附属第九人民医院
Applicant's institution：	The Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University
研究负责人所在单位：	上海交通大学医学院附属第九人民医院
Affiliation of the Leader：	The Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University

是否获伦理委员会批准：	否
Approved by ethic committee：	No
伦理委员会批件文号： Approved No. of ethic committee：		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：
伦理委员会批准日期： Date of approved by ethic committee：	2013-08-26 00:00:00
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：

上海交通大学医学院附属第九人民医院

Primary sponsor：

The Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University

研究实施负责（组长）单位地址：

上海市黄浦区制造局路639号

Primary sponsor's address：

639 Zhizaoju Road, Huangpu District, Shanghai, 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)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属第九人民医院	具体地址：	黄浦区制造局路639号
Institution hospital：	The Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University	Address：	639 Zhizaoju Road, Huangpu District

经费或物资来源：

2019年度申康临床科技创新项目

Source(s) of funding：

2019 Shenkang clinical science and technology innovation project

研究疾病：

牙种植体植入

Target disease：

dental implant placement

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：

探索性研究/预试验

Study phase：

0

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要研究目标：本研究着眼于对比静态导板和动态导航技术在严重牙列缺失即无牙颌患者中种植的精度，通过比较在不同引导技术下种植手术后种植体的偏差以及开展多中心临床试验，对比两种技术应用在无牙颌患者中的精度差异，为精确无牙颌种植提供临床试验依据。次要研究目标：本研究在对比静态导板和动态导航技术在无牙颌患者中应用的精度的同时，对比采用两种引导技术的手术时间、患者感受程度以及种植体存留率，研究在不同引导方式进行种植手术各方面的参数以及临床长期效果，为后期无牙颌患者种植修复时综合考虑各方面因素提供思路。

Objectives of Study：

Main research objectives: This study aims to compare the implant accuracy of static guide plate and dynamic navigation technology in patients with severe dentition loss, i.e. edentulous jaw. By comparing the deviation of implants after implant operation under different guidance technologies and carrying out multi center clinical trials, the accuracy differences between the two technologies in patients with edentulous jaw are compared. Secondary research objectives: in this study, when comparing the accuracy of static guide and dynamic navigation technology in patients with edentulous jaws, we compared the operation time, patient's feeling degree and implant retention rate of the two guiding technologies, and studied the parameters and clinical long-term effects of different guiding methods in all aspects of implant hand operation, so as to provide a comprehensive basis for the later edentulous patients in implant treatment.

药物成份或治疗方案详述：

口腔颅颌面部种植手术往往空间狭窄、位点精确度要求高、术区可能毗邻重要器官、神经、血管等，手术需要十分精准以尽可能避免严重并发症。在复杂牙缺失即无牙颌患者种植手术中采用静态导板和动态导航技术有利于发现两种引导手术方法的优缺点及适应症，节省手术时间，提高手术效率，降低操作疲劳、视觉误差等引起的种植路径偏倚。这是一项前瞻性、随机、阳性对照、多中心的临床试验。在全口无牙颌的中国患者中，对比静态导板和动态导航技术的精确性是本研究的重点。本项目研究内容主要分为以下三大部分：（1）静态导板在复杂牙缺失患者种植手术中的应用及精度分析：口腔手术空间狭窄、术区毗邻重要器官、神经、血管等，例如：眼球、视神经、颞下窝、眶下神经血管束、下颌神经、上颌窦等，手术需要十分精准，才能避免手术的严重并发症。对于无牙颌患者，往往由于缺少牙齿提供位置、方向参数以及固位点，增加了种植位点周围解剖情况的复杂性同时也使导板的固位和稳定受到很大影响，需要研究的内容包括：通过完善的术前规划和评估设计导板，增加无牙颌手术中粘膜支持式导板的稳定性；通过静态导板引导、按照术前规划进行种植体植入术；评估术前规划位置和术后种植体位置的差异，从而分析静态导板在无牙颌种植手术中的精度。（2）动态导航技术在复杂牙缺失患者种植手术中的应用及精度分析：用高精度动态导航仪，将上述步骤处理后的多源医学图像重建的虚拟三维数据、以及手术规划软件生成的规划结果导入手术导航系统，进行空间配准，在2D/3D人机交互的环境下，按照预先设置的手术路径进行手术，确保手术的安全性与精确化研究内容包括：可靠性和实时性分析以及动态导航技术的精度。（3）对比分析静态导板和动态导航技术在无牙颌种植手术中的精度：在中国上海交通大学医学院附属第九人民医院、上海市第六人民医院、复旦大学附属中山医院3 家研究中心开展多中心临床试验，对无牙颌患者随机选用静态导板和动态导航技术植入种植体，将术前CBCT和术后CBCT进行融合，在规划软件上对比种植体和规划路径的入口偏差、尖端偏差以及角度偏差，综合评价静态导板和动态导航技术在无牙颌种植手术中的精度。（4）对比分析静态导板和动态导航技术在无牙颌种植手术中的效果：通过多中心临床试验，对比两种引导种植手术方式在手术时间、患者感受以及种植体存留率即种植的长期效果方面的差异，术后通过统计手术时间、制定考量标准询问患者感受以及在受试者在手术后第10（±4）天进行拆线访视，90（±7）天进行访视，180（±14）天放置愈合基台进行终修复，评估种植体的存留率，在多个方面综合评价采用不同引导方式进行无牙颌种植手术的效果。（5）本次临床试验的主要终点是比较采用静态导板和动态导航技术进行无牙颌种植手术的精度。来自3家研究中心的60名符合入选标准的患者将选入到本研究中，在试验采取任何相关步骤前，受试者需签署知情同意书。合格的受试者按照1:1的比例随机分配到实验组（动态导航组）或对照组（静态导板组），所有受试者种植修复方案需按照ITI第四册指南及结合患者具体情况植入种植体。在手术后拍摄CBCT，受试者在手术后第10（±4）天进行拆线访视，90（±7）天进行访视，180（±14）天放置愈合基台进行终修复，独立的中心实验室将对所有受试者的精度进行评估。

Description for medicine or protocol of treatment in detail：

Oral craniomaxillofacial implant surgery often has narrow space, high accuracy of site requirements, and the operation area may be adjacent to important organs, nerves, blood vessels, etc. the operation needs to be very accurate to avoid serious complications as much as possible. Static guide plate and dynamic navigation technology can help to find the advantages, disadvantages and indications of the two methods, save the operation time, improve the operation efficiency, reduce the implant path bias caused by operation fatigue and visual error. This is a prospective, randomized, positive control, multicenter clinical trial. In Chinese patients with complete edentulous jaws, the focus of this study is to compare the accuracy of static guide plate and dynamic navigation technology. The research content of this project is mainly divided into the following three parts: (1) the application and accuracy analysis of static guide plate in implant surgery for patients with complex tooth loss: the operation space is narrow, the operation area is adjacent to important organs, nerves, blood vessels, etc., such as eyeball, optic nerve, infratemporal fossa, infraorbital nerve vascular bundle, mandibular nerve, maxillary sinus, etc. the operation needs to be very accurate to avoid serious complications of the operation. For patients with edentulous jaws, the lack of tooth location, direction parameters and fixation sites often increases the complexity of the anatomy around the implant site, and also greatly affects the fixation and stability of the guide plate. The research contents include: to increase the stability of the mucosal support guide plate in the edentulous jaw surgery through the perfect preoperative planning and evaluation of the design guide plate. In order to analyze the accuracy of the static guide plate in the edentulous jaw implant operation, the static guide plate was used to guide the implant operation according to the preoperative planning, and the difference between the preoperative planning position and the postoperative implant position was evaluated. (2) application and accuracy analysis of dynamic navigation technology in implant surgery for patients with complex tooth loss: use high-precision dynamic navigator to import the virtual 3D data of multi-source medical image reconstruction processed in the above steps and the planning results generated by the operation planning software into the operation navigation system for spatial registration. Under the environment of 2D / 3D human-computer interaction, follow the preset path. In order to ensure the safety and accuracy of the operation, the research contents include: reliability and real-time analysis as well as the accuracy of dynamic navigation technology. (3) comparative analysis of the accuracy of static guide and dynamic navigation technology in edentulous implant surgery: multi center clinical trials were carried out in the Ninth People's Hospital Affiliated to Shanghai Jiaotong University Medical College, the Sixth People's Hospital of Shanghai and Zhongshan Hospital Affiliated to Fudan University. Patients with edentulous jaws were randomly selected static guide and dynamic navigation technology to implant. In the planning software, the entrance deviation, tip deviation and angle deviation of implant and planning path were compared, and the accuracy of static guide plate and dynamic navigation technology in edentulous implant surgery was comprehensively evaluated. (4) comparative analysis of the effect of static guide plate and dynamic navigation technology in edentulous implant surgery: through the multicenter clinical trial, the differences between the two guided implant surgery methods in the operation time, patients' feelings and implant retention rate, namely, the long-term effect of the implant were compared. After the operation, the patients' feelings were inquired through the statistics of the operation time, the formulation of the consideration standard and the subjects' feelings during the operation. On the 10th (± 4) day after operation, the suture removal visit was conducted, on the 90th (± 7) day after operation, and on the 180th (± 14) day after operation, the healing abutment was placed for final repair. The survival rate of the implant was evaluated, and the effect of different guiding methods for edentulous implant operation was comprehensively evaluated in many aspects. (5) the main end point of this clinical trial is to compare the accuracy of edentulous implant surgery with static guide plate and dynamic navigation technology. 60 eligible patients from 3 centers will be selected for this study, and the subjects need to sign the informed consent before taking any relevant steps in the trial. Qualified subjects were randomly assigned to the experimental group (dynamic navigation group) or the control group (static guide group) according to the proportion of 1:1. All subjects were required to implant implants according to the guidelines of Volume IV of ITI and the specific situation of patients. After the operation, CBCT was taken. The subjects were followed up on the 10th (± 4) day, 90 (± 7) day and 180 (± 14) day after the operation. The independent central laboratory will evaluate the accuracy of all subjects.

纳入标准：

Inclusion criteria

排除标准：

1) 口腔粘膜病变(如扁平苔藓)
2) 口腔存在占位性病变(包括囊肿、肿瘤等)；
3) 影响骨愈合，伤口愈合和牙齿种植治疗的系统疾病(如未控制稳定的糖尿病，经药物控制空腹血糖仍≥8.8mmoL)；
4) 未控制稳定的严重高血压；
5) 常规种植手术和口腔手术，包括植骨手术的禁忌症；
6) 心脏疾病(Ⅱ级及以上心功能疾病)；
7) 肝肾功能不全或异常的患者；
8) 肥胖症患者，体重指数BMI>28kg/m；
9) 接受全剂量放疗，头部或颈部的局部放疗史；
10) 需要长期高剂量类固醇治疗的患者；
11) 正在或近3个月内曾接受可能影响或促进骨代谢的药物(如双磷酸盐)治疗的患者；
12) 在开始手术的前4周内，连续使用抗生素治疗或慢性抗炎治疗(每周≥3次)；
13) 酗酒或长期药物滥用；
14) 免疫功能不全的患者；
15) 每天吸烟烟草等价物/咀嚼烟草大于10根；
16) 身体或精神缺陷影响进行口腔卫生护理；
17) 对产品过敏的患者；
18) 怀孕或哺乳期的女性患者；
19) 研究者认为依从性不好不能参与试验的患者；
20) 在开始手术(研究第0天)的前30天内，患者参与了其他药物或器械的临床试验。

Exclusion criteria：

1) oral mucosal lesions (such as lichen planus);
2) the oral cavity has space occupying lesions (including cyst, tumor, etc.);
3) systemic diseases that affect bone healing, wound healing and dental implant therapy (such as uncontrolled and stable diabetes, the fasting blood glucose was still >= 8.8 mmol);
4) uncontrolled and stable severe hypertension;
5) contraindications of conventional implant and oral surgery, including bone grafting;
6) heart disease (grade II or above heart function disease);
7) patients with liver and kidney dysfunction or abnormality;
8) obesity patients, BMI > 28KG / M;
9) received full dose radiotherapy, local radiotherapy history of head or neck;
10) patients requiring long-term high-dose steroid treatment;
11) patients have been treated with drugs (such as bisphosphate) that may affect or promote bone metabolism in the past 3 months;
12) in the first 4 weeks of operation, antibiotic treatment or chronic anti-inflammatory treatment (at least 3 times a week) was used continuously;
13) alcoholism or long-term drug abuse;
14) patients with incomplete immune function;
15) smoking tobacco equivalent / chewing tobacco more than 10 cigarettes per day;
16) physical or mental defects affect oral health care;
17) patients who are allergic to the product;
18) pregnant or lactating female patients;
19) patients with poor compliance who could not participate in the trial, according to the researchers; 20) within the first 30 days of the operation (day 0), the patient participated in clinical trials of other drugs or devices.

研究实施时间：

Study execute time：

从 From 2019-11-30 00:00:00至 To 2022-11-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-04-01 00:00:00 至 To 2021-04-01 00:00:00

干预措施：

Interventions：

组别：	动态导航组	样本量：	30
Group：	dynamic guided group	Sample size：	30
干预措施：	实时动态导航辅助种植体植入	干预措施代码：
Intervention：	dynamic guided implant placement	Intervention code：

组别：	静态导板组	样本量：	30
Group：	static guided group	Sample size：	30
干预措施：	静态导板辅助种植体植入	干预措施代码：
Intervention：	static guided implant placement	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属第九人民医院	单位级别：	三级甲等
Institution hospital：	Ninth People's Hospital, College of Stomatology, Shanghai Jiaotong University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海第六人民医院	单位级别：	三级甲等
Institution hospital：	Shanghai Sixth People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属中山医院	单位级别：	三级甲等
Institution hospital：	Zhongshan Hospital Affiliated to Fudan University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	种植体入口偏差	指标类型：	主要指标
Outcome：	entry deviation of implant	Type：	Primary indicator
测量时间点：		测量方法：	术前术后CBCT融合
Measure time point of outcome：		Measure method：	CBCT fusion

指标中文名：	种植体出口偏差	指标类型：	主要指标
Outcome：	apical deviation of implant	Type：	Primary indicator
测量时间点：		测量方法：	术前术后CBCT融合
Measure time point of outcome：		Measure method：	CBCT fusion

指标中文名：	种植体角度偏差	指标类型：	主要指标
Outcome：	angle deviation of implant	Type：	Primary indicator
测量时间点：		测量方法：	术前术后CBCT融合
Measure time point of outcome：		Measure method：	CBCT fusion

指标中文名：	手术时间	指标类型：	次要指标
Outcome：	operation time	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	患者满意程度	指标类型：	次要指标
Outcome：	Patient satisfaction	Type：	Secondary indicator
测量时间点：		测量方法：	填写问卷
Measure time point of outcome：		Measure method：	sign questionnaire

指标中文名：	种植体存留率	指标类型：	次要指标
Outcome：	implant survival rate	Type：	Secondary indicator
测量时间点：	术后10、90、180天	测量方法：
Measure time point of outcome：	Postoperative 10, 90, 180 days	Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	blood	Tissue：
人体标本去向	使用后销毁	说明	术前检查
Fate of sample：	Destruction after use	Note：	preoperative examination

标本中文名：	尿液	组织：
Sample Name：	urine	Tissue：
人体标本去向	使用后销毁	说明	术前检查
Fate of sample：	Destruction after use	Note：	preoperative examination

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		岁 years
最大 Max age		岁 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）：

随机：本研究将采用交互式网络响应系统（interactive web response system，IWRS），在系统中，负责随时化的统计师在后台事先设计好随机化参数，由系统生成随机分配表。研究者通过电话或网络访问服务器，输入入组患者的信息后，由系统根据机分配表给出相应的编号及相应组别，避免了研究者和受试者有意选择组别。此外，在由于考虑将分中心作为一个分层因素的研究中，通过中央随机系统来统一控整个试验随机方案的分配，各分中心可竞争随机入组，不仅可以有效地避免因各分中心试进度不一导致的延期，缩短临床试验周期，同时也能保障整个试验中组间的均衡，申办者也可以实时掌握各分中心受试者入组进度并进行调整优化。

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

Random: This study will use interactive Web response system (IWRS). In the system, the statistician in charge of the randomization will design the random parameters in advance in the background, and the system will generate the random allocation table. Researchers access the server by telephone or network, inpu

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	盲法：对负责影像评估人员设盲，禁止其获知受试者分组组别，避免主观因素影响试验指标的评价而出现偏倚。
Blinding：	Blind method: blind the person in charge of image evaluation, forbid them to know the group of subjects, and avoid bias caused by subjective factors affecting the evaluation of test indexes.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
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）：	2023年2月文章发表
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	2023.2 Article publication
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：	本研究采用电子数据收集系统(EDC)。由指定的研究中心工作人员按照研究方案的要求将数据录入到电子病历报告表(CRF)中。研究者所在研究中心的工作人员只有在接受了培训之后方可进入EDC系统。主研究者(PI)负责确保录入到eCRF中的数据是完整和准确的,并且是及时录入和更新的数据。研究者通过在受试者的eCRF上进行电子签名确认审阅并批准此记录。申办者/CRO将对研究中心工作人员录入到CRF中数据的完整性与准确性进行审核。将创建说明问题性质并且要求进行澄清的电子数据询问表,对偏差、缺失值进行询问,随后将通过EDC系统发送至研究中心。要求由研究者指定的研究中心工作人员对询问表立即进行回答,并对数据作出任何必要的变更。在数据审核并确认建立的数据库正确后,由数据管理人员、主要研究者、统计分析人员、实施者和监查管理人员共同对数据进行审核,并完成分析人群的最后定义及判断,之后对数据进行锁定。锁定后的数据或文件不再做改动。数据锁定之后发现的问题,经确认后在统计分析程序中进行修正。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Electronic data collection system (EDC) was used in this study. The designated research center staff will input the data into the electronic medical record report form (CRF) according to the requirements of the research plan. The staff of the researcher's research center can only enter the EDC system after receiving the training. The primary investigator (PI) is responsible for ensuring that the data entered into the ECRF is complete and accurate, and is timely entered and updated. The researchers confirmed the review and approval of the record by electronic signature on the subject's ECRF. The sponsor / cro will review the integrity and accuracy of the data entered into CRF by the staff of the research center. An electronic data inquiry form will be created to explain the nature of the problem and ask for clarification, asking for deviation and missing value, and then sent to the research center through EDC system. The staff of the research center designated by the researcher is required to answer the inquiry form immediately and make any necessary changes to the data. After the data is reviewed and the established database is confirmed to be correct, data management personnel, main researchers, statistical analysts, implementers and audit management personnel jointly review the data, complete the final definition and judgment of the analysis population, and then lock the data. The locked data or file will not be changed. Problems found after data locking shall be corrected in the statistical analysis program after confirmation.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2019-10-20 10:32:11