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：	ChiCTR2400081737
最近更新日期： Date of Last Refreshed on：	2024-03-11 11:09:13
注册时间： Date of Registration：	2024-03-11 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	全程数字化技术在可摘局部义齿修复中的应用
Public title：	The application of full digital technology on removable partial dentures
注册题目简写：
English Acronym：
研究课题的正式科学名称：	全程数字化技术在可摘局部义齿领域的临床应用研究
Scientific title：	The research on clinical application of full digital technology on removable partial dentures
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：	于海	研究负责人：	吴江
Applicant：	Yu Hai	Study leader：	Wu Jiang
申请注册联系人电话： Applicant telephone：	+86 29 8477 6121	研究负责人电话： Study leader's telephone：	+86 135 7181 9839
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：	82066117@qq.com	研究负责人电子邮件： Study leader's E-mail：	82066117@qq.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：	陕西省西安市新城区长乐西路145号	研究负责人通讯地址：	陕西省西安市新城区长乐西路145号
Applicant address：	No.145 Changlexi ST, Xi'an, Shaanxi	Study leader's address：	No.145 Changlexi ST, Xi'an, Shaanxi
申请注册联系人邮政编码： Applicant postcode：	710032	研究负责人邮政编码： Study leader's postcode：	710032
申请人所在单位：	第四军医大学口腔医院
Applicant's institution：	School of Stomatology, Fourth Military Medical University
研究负责人所在单位：	第四军医大学口腔医院
Affiliation of the Leader：	School of Stomatology, Fourth Military 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：	IRB-REV-2020055	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：	中国人民解放军第四军医大学口腔医院医学伦理委员会
Name of the ethic committee：	Institutional Review Board of School of Stomatology, Fourth Military Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2020-07-29 00:00:00
伦理委员会联系人：	成黎霏
Contact Name of the ethic committee：	Cheng Lifei
伦理委员会联系地址：	陕西省西安市新城区长乐西路145号
Contact Address of the ethic committee：	No.145 Changlexi ST, Xi'an, Shaanxi
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 135 7207 3096	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：

第四军医大学口腔医院

Primary sponsor：

School of Stomatology, Fourth Military Medical University

研究实施负责（组长）单位地址：

陕西省西安市新城区长乐西路145号

Primary sponsor's address：

No.145 Changlexi ST, Xi'an, Shaanxi

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	陕西	市(区县)：	西安
Country：	China	Province：	Shaanxi	City：	Xi'an
单位(医院)：	第四军医大学口腔医院	具体地址：	陕西省西安市新城区长乐西路145号
Institution hospital：	School of Stomatology, Fourth Military Medical University	Address：	No.145 Changlexi ST, Xi'an, Shaanxi

经费或物资来源：

国家口腔疾病临床医学研究中心

Source(s) of funding：

National Clinical Research Center for Oral Diseases

研究疾病：

牙列缺损

Target disease：

Dentition Defect

研究疾病代码：

Target disease code：

研究类型：

治疗研究

Study type：

Treatment study

研究所处阶段：

治疗新技术临床试验

Study phase：

New Treatment Measure Clinical Study

研究设计：

病例研究

Study design：

Case study

研究目的：

应用口扫、CAD和3D打印技术，制备新型功能性印模托盘，以此为基础快速获取游离端/非游离端牙列缺损的数字化印模，并对其精度进行客观评价。在上述数字化印模基础上，应用CAD设计具有特殊结构的可摘局部义齿支架与人工牙部分结构，结合3D打印和CAM技术，快速完成制作。打印为主要技术手段，进行可摘局部义齿支架的快速制作，并对其精确度进行客观评价及优化；同时结合特殊连接方式结合，形成新型可摘局部义齿的制作。整合上述技术手段，形成“临床接诊—义齿制作”的全数字化制作方法，并初步应用于临床，对适合性进行全面评价，最终提出该方法制作可摘局部义齿的技术规范。推动数字化及3D 打印技术的应用和普及，促进口腔修复学技术进步，造福广大缺牙患者。

Objectives of Study：

A new type of functional impression tray is prepared by applying oral scanning, CAD and 3D printing technologies, based on which digital impressions of free-end/non-free-end dental defects are quickly obtained and their accuracy is objectively evaluated. On the basis of the above digital impression, CAD is applied to design removable partial denture bracket with special structure and artificial tooth partial structure, and combined with 3D printing and CAM technology, the fabrication is completed quickly. Printing is the main technical means for the rapid fabrication of removable partial denture brackets and objective evaluation and optimization of their accuracy; at the same time, the fabrication of a new type of removable partial denture is formed by combining with a special connection method. By integrating the above technical means, a fully digitalized production method of "clinical consultation - denture production" will be formed, and initially applied to the clinic, with a comprehensive evaluation of its suitability, and ultimately put forward the technical specifications for the production of removable partial dentures by this method. This will promote the application and popularization of digital and 3D printing technology, promote the progress of prosthodontics technology, and benefit the majority of patients with missing teeth.

药物成份或治疗方案详述：

1.牙列缺损患者数字化印模的快速制取、重建和精度分析 1.1非游离端牙列缺损数字化印模的快速制取、重建和精度分析采用传统印模技术取模，翻制石膏模型使用台式扫描仪扫描石膏模型进行数字化模型构建，并作为标准对照；分别使用3种不同口扫设备口内直接扫描采集患者牙列缺损模型的光学印模，应用逆向工程软件进行三维模型重建（重建参数保持一致），对上述不同的口扫重建模型进行精度分析。 1.2 游离端牙列缺损数字化印模的快速制取、重建和精度分析采用标准修正印模技术对游离端牙列缺损进行印模制取（单/双游离端），翻制石膏模型使用台式扫描仪扫描石膏模型进行数字化模型构建，并作为标准对照；分别使用3种不同口扫设备口内直接扫描采集患者牙列缺损模型的光学印模，应用逆向工程软件进行三维模型重建（重建参数保持一致），对上述不同的口扫重建模型进行精度分析。 1.3新型数字化修正印模技术制取游离端牙列缺损数字化印模及精度分析在1.2的基础上，通过CAD设计具有开窗功能的新型个别托盘并使用3D打印技术进行制作，口内试戴后采用一步法直接制取压力性印模，对印模/模型进行数据扫描。将获得的数据与初印模数据的牙列数据进行拟合与重建，直接完成数字化修正印模的构建，并与传统修正印模技术进行印模精度比较和分析。 2. 可摘局部义齿钛金属支架的CAD设计和3D打印精度对比分析 2.1使用CAD软件设计可摘局部义齿支架，并在支架的缺牙区优化，制备出具有特殊结构的连接体，为可摘义齿的人工牙提供数字化修复基础。进一步根据该部分连接体，设计数字化人工牙或基托。 2.2 使用3D打印（SLM技术）直接制作可摘局部义齿支架。制备后的支架经过临床标准处理后，再次扫描重建，与原始支架数据进行精度对比分析。根据相关结果，在加工软件设计中需要合理补偿收缩，合理设计支撑，保证制作精度与适合性。与传统包埋铸造技术进行对比，统计分析。 3. 全程数字化与传统工艺制作可摘局部义齿的临床应用对比研究按照Kenndy分类，选择I-IV类不同患者分别进行数字化印模的制取、CAD设计和可摘局部义齿的数字化加工和传统制作加工。患者分别佩戴传统和数字化技术制作义齿，佩戴后分别在佩戴当日、1周、1个月、6个月、12个月进行适合性分析，采用问卷调查方式，对结果进行统计汇总，评价不同方法制作义齿的疗效，为临床提供参考。

Description for medicine or protocol of treatment in detail：

1. Reconstruction and accuracy analysis of digital impressions for patients with dental defects 1.1 Reconstruction and accuracy analysis of digital impression of non-free end dentition defect The traditional impression technology is used to take the mold, turn the plaster model, and the desktop scanner is used to scan the plaster model for digital model construction, and as a standard reference; The optical impressions of the patients' dental defect models were collected by direct intraoral scanning of three different oral scanning devices, and the 3D model was reconstructed by reverse engineering software (reconstruction parameters were consistent). The accuracy of the above different oral scan reconstruction models was analyzed. 1.2 Rapid production, reconstruction and accuracy analysis of digital impression of free end dentition defect Standard modified impression technology was used to make impression (single/double free end) of the free end dentition defect, and the plaster model was turned over. The digital model was constructed by scanning the plaster model with bench scanner, and was used as a standard reference. The optical impressions of the patients' dental defect models were collected by direct intraoral scanning of three different oral scanning devices, and the 3D model was reconstructed by reverse engineering software (reconstruction parameters were consistent). The accuracy of the above different oral scan reconstruction models was analyzed. 1.3 New digital correction impression technology to produce free end dentition defect digital impression and accuracy analysis On the basis of 1.2, a new type of individual tray with window opening function was designed by CAD and made using 3D printing technology. After oral trial, pressure impression was directly made by one-step method, and data scanning was performed on impression/model. The obtained data is fitted and reconstructed with the dentition data of the initial impression data, and the digital correction impression is constructed directly, and the accuracy of the impression is compared and analyzed with the traditional correction impression technology. 2. Comparative analysis of CAD design and 3D printing accuracy of removable partial denture titanium framework 2.1 CAD software was used to design the removable partial denture support, and the missing tooth area of the support was optimized to prepare a connection with a special structure, which provided the digital restoration basis for the removable artificial teeth. According to the partial connectome, the digital artificial tooth or base is designed. 2.2 Use 3D printing (SLM technology) to directly produce removable partial denture supports. After clinical standard treatment, the prepared stent was scanned and reconstructed again, and the accuracy was compared with the original stent data. According to the relevant results, it is necessary to reasonably compensate the shrinkage and design the support in the design of machining software to ensure the production accuracy and suitability. Compared with traditional embedding casting technology, statistical analysis was made. 3. Comparative study on the clinical application of full-process digital and traditional manufacturing of removable partial dentures According to Kenndy classification, different patients in class I-IV were selected for digital impression preparation, CAD design, digital processing of removable partial denture and traditional processing. Patients wore dentures made by traditional and digital technologies respectively. Suitability analysis was conducted on the day of wearing, 1 week, 1 month, 6 months and 12 months after wearing, and the results were statistically summarized by means of questionnaire survey, so as to evaluate the efficacy of dentures made by different methods and provide clinical reference.

纳入标准：

Inclusion criteria

排除标准：

精神、身体等因素无法完成可摘义齿修复；或不接受可摘局部义齿修复的患者。

Exclusion criteria：

Patients who are mentally or physically unable to complete removable denture restorations; or who do not accept removable partial denture.

研究实施时间：

Study execute time：

从 From 2020-07-01 00:00:00至 To 2024-05-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2020-08-05 00:00:00 至 To 2024-05-31 00:00:00

干预措施：

Interventions：

组别：	传统修复方式	样本量：	50
Group：	Traditional porcess	Sample size：	50
干预措施：	使用传统方法取模并制作可摘局部义齿。	干预措施代码：
Intervention：	Impression and RPD fabrication with traditional method	Intervention code：

组别：	全程数字化修复	样本量：	50
Group：	Full digital process	Sample size：	50
干预措施：	使用数字化方法取模并制作可摘局部义齿	干预措施代码：
Intervention：	Impression and RPD fabrication with digital method	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	陕西	市(区县)：	西安
Country：	China	Province：	Shaanxi	City：	Xi'an
单位(医院)：	第四军医大学口腔医院	单位级别：	三甲
Institution hospital：	School of Stomatology, Fourth Military Medical University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京口腔医院	单位级别：	三甲
Institution hospital：	Beijing Stomatological Hospital of Capital Medical University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	重庆	市(区县)：
Country：	China	Province：	Chongqing	City：
单位(医院)：	重庆医科大学附属口腔医院	单位级别：	三甲
Institution hospital：	Stomatological Hospital of Chongqing Medical University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	重庆	市(区县)：
Country：	China	Province：	Chongqing	City：
单位(医院)：	陆军军医大学第一附属医院	单位级别：	三甲
Institution hospital：	First Affiliated Hospital of Army Military Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	义齿适合性	指标类型：	主要指标
Outcome：	Fitness	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	问卷调查	指标类型：	次要指标
Outcome：	questionnaire	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：

标本中文名：	无	组织：
Sample Name：	N/A	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	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	20	岁 years
最大 Max age	75	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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：
Blinding：

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）：	http://www.medresman.org.cn/login.aspx
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	http://www.medresman.org.cn/login.aspx
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：	病例记录表
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
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：	2024-03-11 11:09:09