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Research on time series CBCT image fusion for patients with temporomandibular joint osteoarthropathy
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注册号:

Registration number:

ChiCTR2200060049 

最近更新日期:

Date of Last Refreshed on:

2022-05-16 

注册时间:

Date of Registration:

2022-05-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

面向颞下颌关节骨关节病患者时间序列CBCT图像融合研究 

Public title:

Research on time series CBCT image fusion for patients with temporomandibular joint osteoarthropathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

面向颞下颌关节骨关节病患者时间序列CBCT图像融合研究 

Scientific title:

Research on time series CBCT image fusion for patients with temporomandibular joint osteoarthropathy 

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:

冯继玲 

研究负责人:

李刚 

Applicant:

Feng Jiling 

Study leader:

Li Gang 

申请注册联系人电话:

Applicant telephone:

19801115663 

研究负责人电话:

Study leader's telephone:

15120060267 

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:

2661296379@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

kqgang@bjmu.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:

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:

No.22,Zhongguancun Nandajie,Haidian District,Beijing,China 

Study leader's address:

No.22,Zhongguancun Nandajie,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:

北京大学口腔医学院 

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- 201944056 

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:

Institutional Review Board of Peking University School and Hospital of Stomatology 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

贾效伦 

Contact Name of the ethic committee:

 

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:

No.22,Zhongguancun Nandajie,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:

北京大学口腔医学院 

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:

No.22,Zhongguancun Nandajie,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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学口腔医院

具体地址:

北京市海淀区中关村南大街22号

Institution
hospital:

Peking University School and Hospital of Stomatology

Address:

No.22,Zhongguancun Nandajie,Haidian District,Beijing,China

经费或物资来源:

北京大学百度基金(No. 2020BD037),国家自然科学基金 (No. 81671034)。 

Source(s) of funding:

PKU Baidu Fund (No. 2020BD037) and the National Natural Science Foundation of China (No. 81671034). 

研究疾病:

颞下颌关节骨关节病 

Target disease:

Tempromandibular joint osteoarthritis 

研究疾病代码:

 

Target disease code:

 

研究类型:

诊断试验 

Study type:

Diagnostic test 

研究所处阶段:

诊断试验新技术临床试验 

Study phase:

Diagnostic New Technique Clincal Study 

研究目的:

通过使用时间序列CBCT图像融合技术诊断颞下颌关节骨关节病患者在随访或治疗期间疾病的进展及转归情况,并与目前临床上使用的直接对比观察的方式进行比较,以期提高对颞下颌关节骨关节病患者的诊疗水平。 

Objectives of Study:

Through the use of time series CBCT image fusion technology to diagnose the disease progress and prognosis of patients with temporomandibular joint osteoarthropathy during follow-up or treatment, and compare it with the direct comparative observation method currently used in clinic, in order to improve the diagnosis and treatment level of patients with temporomandibular joint osteoarthropathy. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

诊断试验诊断准确性 

Study design:

Diagnostic test for accuracy 

纳入标准:

1.综合病史、临床及影像学检查诊断为颞下颌关节骨关节病的患者 2.CBCT图像包括完整的颞下颌关节并无运动伪影 3.两个时间点拍摄的CBCT图像间隔至少3个月 4.患者年龄大于18岁 

Inclusion criteria

(1) by overviewing clinical symptoms, medical history and imaging examination, the patient was diagnosed as TMJ osteoarthritis according to Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) ; (2) the acquired image data included the full TMJ structures and there was no motion artifact; (3) the interval between two CBCT examinations was more than or equal to 3 months; (4) the age of patient was beyond 18 years old 

排除标准:

1.没有明确的颞下颌关节骨关节病诊断者 2.CBCT图像质量较差,影响髁突骨质观察者 3.患者年龄低于18岁者 

Exclusion criteria:

(1) the patient had no definite diagnosis of TMJ osteoarthritis; (2) The quality of CBCT image was poor and affected the observation of condylar bone changes; (3) the age of patient was under 18 years old.  

研究实施时间:

Study execute time:

From2022-05-01To 2024-06-01 

征募观察对象时间:

Recruiting time:

From2022-05-01To 2022-08-01 

诊断措施:

Diagnostic measures:

金标准或参考标准(即可准确诊断某疾病的单项方法或多项联合方法,在本研究中用于诊断是否有该病的临床参考标准):

由 1 名具有 25 年以上工作经验的口腔颌面医学影像科专家和 2 名具有 30 年以上工作经验的颞下颌关节病及口面痛治疗中心的专家组成专家组。专家组根据病史、临床检查和所有影像学检查图像(两个时间点的CBCT图像以及融合后断层图像以及3D图像),判断第二个时间点的髁突是否发生了骨质吸收,经过商议达成共识。将专家 组的诊断结果作为参考标准。

Gold Standard or Reference Standard (The clinical reference standards required to establish the presence or absence of the target condition in the tested population in present study):

One specialist with an experience of over 25 years in oral and maxillofacial radiology and two certified specialists with an experience of over 30 years in oral and maxillofacial surgery (mainly for diagnosis and conservative treatment of TMJ disease) acted as expert panel. The specialists individually determined&#

指标试验(即本研究的待评估诊断试验,无论为方法、生物标志物或设备,均请列出名称):

融合两个时间点的CBCT图像获得的断层图像和3D图像

Index test:

fused sectional images and fused 3D images based on two time points of CBCT datda

目标人群(可以是某种疾病患者或正常人群,详细描述其疾病特征,注意应纳入符合分布特点的全序列病例,具有良好的代表性)

患颞下颌关节骨关节病患者中,在至少三个月的随访或治疗后髁突骨质发生了吸收的患者

例数:

Sample size:

23

Target condition (The target condition is a particular disease or disease stage that the index test will be intended to identify. Please specify the characteristics in detail; the population should has a complete spectrum and good representative):

In patients with temporomandibular joint osteoarthropathy, condylar bone resorption occurred after at least three months of follow-up or treatment

容易混淆的疾病人群(即与目标疾病不易区分的一种或多种不同疾病,应避免采用正常人群对照的病例-对照设计):

颞下颌关节骨关节病患者中,在至少三个月的随访或治疗后髁突骨质没有发生变化

例数:

Sample size:

8

Population with condition difficult to distinguish from the target condition, the normal population in a case-control study design should be avoid:

In patients with temporomandibular joint osteoarthropathy, there was no change in condylar bone after at least three months of follow-up or treatment

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

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:

third-grade class-A 

测量指标:

Outcomes:

指标中文名:

吸收

指标类型:

主要指标 

Outcome:

resorption

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:

CBCT影像数据

组织:

Sample Name:

CBCT data

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

本实验的研究者采用随机数表的方法,对符合纳入条件的样本进行随机选取。首先对所有符合纳入标准的样本进行自然数列编码,然后使用SPSS软件产生随机数列,选择研究样本。

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

The researchers of this experiment used the method of random number table to randomly select the samples that meet the inclusion conditions. Firstly, all samples that meet the inclusion criteria are coded by natural sequence, and then the random sequence is generated by SPSS software to select the research&

盲法:

Blinding:

是否共享原始数据:

IPD sharing

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):

NO

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:

NO

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2022-05-16
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