各种埋伏牙的精准诊断治疗体系的构建的研究

注册号:

Registration number:

ChiCTR2600120063 

最近更新日期:

Date of Last Refreshed on:

2026-03-09 11:09:37 

注册时间:

Date of Registration:

2026-03-09 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

各种埋伏牙的精准诊断治疗体系的构建的研究

Public title:

Research on the Construction of a Precise Diagnosis and Treatment System for Impacted Teeth

注册题目简写:

English Acronym:

研究课题的正式科学名称:

各种埋伏牙的精准诊断治疗体系的构建的研究

Scientific title:

Research on the Construction of a Precise Diagnosis and Treatment System for Impacted Teeth

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:

胡荣党 

研究负责人:

胡荣党 

Applicant:

Rongdang Hu 

Study leader:

Rongdang Hu 

申请注册联系人电话:

Applicant telephone:

+86 577 88063012

研究负责人电话:

Study leader's
telephone:

+86 577 8806 6005

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:

hurongdang@hotmail.com

研究负责人电子邮件:

Study leader's E-mail:

353978071@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:

浙江省温州市学院西路113号

研究负责人通讯地址:

浙江省温州市学院西路113号

Applicant address:

No. 113, Xueyuan West Road, Wenzhou City, Zhejiang Province

Study leader's address:

No. 113, Xueyuan West Road, Wenzhou City, Zhejiang Province

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:

温州医科大学附属口腔医院

Applicant's institution:

School and Hospital of Stomatology, Wenzhou Medical University

研究负责人所在单位:

温州医科大学附属口腔医院

Affiliation of the Leader:

School and Hospital of Stomatology, Wenzhou Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

温医大口腔医学伦审2026研第010号

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:

温州医科大学附属口腔医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Hospital of Stomatology, Wenzhou Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-02-04 00:00:00

伦理委员会联系人:

王奕

Contact Name of the ethic committee:

Wang Yi

伦理委员会联系地址:

浙江省温州市学院西路113号

Contact Address of the ethic committee:

No. 113, Xueyuan West Road, Wenzhou City, Zhejiang Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 577 88066005

伦理委员会联系人邮箱:

Contact email of the ethic committee:

y.wang@wmu.edu.cn

研究实施负责(组长)单位:

温州医科大学附属口腔医院

Primary sponsor:

School and Hospital of Stomatology, Wenzhou Medical University

研究实施负责(组长)单位地址:

浙江省温州市学院西路113号

Primary sponsor's address:

No. 113, Xueyuan West Road, Wenzhou City, Zhejiang Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江省

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医科大学附属口腔医院

具体地址:

浙江省温州市学院西路113号

Institution
hospital:

School and Hospital of Stomatology, Wenzhou Medical University

Address:

No. 113, Xueyuan West Road, Wenzhou City, Zhejiang Province

经费或物资来源:

临床研究专项经费

Source(s) of funding:

Clinical Research Special Fund

研究疾病:

埋伏牙  

Target disease:

Impacted teeth

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

连续入组 

Study design:

Sequential 

研究目的:

本次研究希望通过分析500多例大样本的上下颌骨埋伏牙病例治疗过程中的CBCT等影像学资料,明确各种埋伏牙的三维空间位置,制定各种埋伏牙科学合理的分类标准。同时测量分析各种埋伏牙的三维空间位置和形态特征,埋伏牙周围骨组织的三维位置形态,研究埋伏牙的可视化牵引路径和有限元生物力学,为临床医生构建各种埋伏牙的精准诊断治疗体系提供借鉴。  

Objectives of Study:

This study aims to analyze over 500 large-sample imaging datasets, including CBCT, from the treatment process of impacted teeth in the maxilla and mandible. The objective is to clarify the three-dimensional spatial positioning of various impacted teeth and establish a scientifically robust classification standard. Additionally, the study seeks to measure and analyze the three-dimensional spatial positioning and morphological characteristics of different impacted teeth, as well as the three-dimensional positioning and morphology of the surrounding bone tissue. By investigating the visualized traction paths and finite element biomechanics of impacted teeth, this research aspires to provide a reference for clinicians in constructing a precise diagnostic and therapeutic system for diverse types of impacted teeth.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

Exclusion criteria:

None

研究实施时间:

Study execute time:

From 2025-07-01 00:00:00 To 2028-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-03-12 00:00:00 To 2028-06-30 00:00:00

干预措施:

Interventions:

组别:

埋伏牙组

样本量:

500

Group:

Impacted tooth group

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

浙江省 

市(区县):

 

Country:

China

Province:

Zhejiang

City:

单位(医院):

温州医科大学附属口腔医院 

单位级别:

三级甲等 

Institution
hospital:

School and Hospital of Stomatology, Wenzhou Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

埋伏牙和牙槽骨的位置形态参数及牵引路径

指标类型:

主要指标

Outcome:

Positional and morphological parameters of impacted teeth and alveolar bone, and traction paths

Type:

Primary indicator

测量时间点:

埋伏牙治疗前;埋伏牙治疗后

测量方法:

CBCT测量

Measure time point of outcome:

Before treatment for impacted teeth; after treatment for impacted teeth

Measure method:

Cone-beam computed tomography (CBCT) measurement

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

NA

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:

尚未开始

Not yet 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):

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:

None

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):

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

None

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:

电子采集和管理系统(EDC)

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

management system include a CRF and an electronic data capture

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-03-09 11:09:28