基于左下颌磨牙CBCT影像的年龄推断研究

注册号:

Registration number:

ChiCTR2600125689 

最近更新日期:

Date of Last Refreshed on:

2026-05-29 14:14:59 

注册时间:

Date of Registration:

2026-05-29 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

基于左下颌磨牙CBCT影像的年龄推断研究

Public title:

A Study on Age Estimation Based on CBCT Images of Left Mandibular Molars

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于左下颌磨牙CBCT影像的年龄推断研究

Scientific title:

A Study on Age Estimation Based on CBCT Images of Left Mandibular Molars

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:

张雅云 

研究负责人:

曾东林 

Applicant:

Zhang Yaying 

Study leader:

Zeng Donglin 

申请注册联系人电话:

Applicant telephone:

+86 20 83870411

研究负责人电话:

Study leader's
telephone:

+86 20 83870411

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:

806152256@qq.com

研究负责人电子邮件:

Study leader's E-mail:

zengdonglin@163.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:

中国广东省广州市越秀区陵园西路56号

研究负责人通讯地址:

中国广东省广州市越秀区陵园西路56号

Applicant address:

56 Lingyuan West Road, Yuexiu District, Guangzhou, Guangdong, China

Study leader's address:

56 Lingyuan West Road, Yuexiu District, 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:

中山大学附属口腔医院

Applicant's institution:

Hospital of Stomatology, SunYat-sen University

研究负责人所在单位:

中山大学附属口腔医院

Affiliation of the Leader:

Hospital of Stomatology, SunYat-sen 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:

KQEC-2025-198-01

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:

中山大学附属口腔医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Hospital of Stomatology, Sun Yat-sen University

伦理委员会批准日期:

Date of approved by ethic committee:

2026-01-21 00:00:00

伦理委员会联系人:

向媛媛

Contact Name of the ethic committee:

Xiang Yuanyuan

伦理委员会联系地址:

中国广东省广州市越秀区陵园西路56号

Contact Address of the ethic committee:

56 Lingyuan West Road, Yuexiu District, Guangzhou, Guangdong, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 83844247

伦理委员会联系人邮箱:

Contact email of the ethic committee:

463563264@qq.com

研究实施负责(组长)单位:

中山大学附属口腔医院

Primary sponsor:

Hospital of Stomatology, SunYat-sen University

研究实施负责(组长)单位地址:

中国广东省广州市越秀区陵园西路56号

Primary sponsor's address:

56 Lingyuan West Road, Yuexiu District, 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):

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属口腔医院

具体地址:

中国广东省广州市越秀区陵园西路56号

Institution
hospital:

Hospital of Stomatology, SunYat-sen University

Address:

56 Lingyuan West Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

自筹

Source(s) of funding:

Self-funded

研究疾病:

第一磨牙、第二磨牙及第三磨牙的发育特征  

Target disease:

Developmental characteristics of the first, second and third molars

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:

横断面 

Study design:

Cross-sectional 

研究目的:

依据10-18岁年龄段人群的CBCT影像,基于左下颌第一、第二及第三磨牙的发育特征建立年龄推断模型,为法医学的真实年龄判断提供一种客观依据与有效手段。通过分析不同年龄阶段的第一磨牙、第二磨牙及第三磨牙特征,进一步阐明第一磨牙、第二磨牙及第三磨牙的发育状况与实际年龄之间的关系。  

Objectives of Study:

Based on CBCT images of individuals aged 10 to 18 years, an age estimation model is established based on the developmental characteristics of the left mandibular first, second, and third molars. This model provides an objective basis and effective method for forensic age determination. By analyzing the characteristics of the first, second, and third molars at different age stages, the relationship between the developmental status of these molars and actual age is further clarified.

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:

1. 左下颌第一磨牙、第二磨牙及第三磨牙的CBCT影像显示不够清晰; 2. 正在接受正畸治疗; 3. 左下颌第一磨牙、第二磨牙及第三磨牙有龋齿、外伤史、根管治疗史及存在修复体; 4. 左下颌磨牙区域颌骨有囊肿、肿瘤及瘤样病变; 5. 影响牙齿发育的全身疾病史。

Exclusion criteria:

1. The CBCT images of the left mandibular first molar, second molar, and third molar are not clear enough; 2. Currently undergoing orthodontic treatment; 3. The left mandibular first molar, second molar, and third molar exhibit caries, a history of trauma, a history of root canal treatment, and the presence of dental restorations; 4. Cysts, tumors, and tumor-like lesions are present in the left mandibular molar region; 5. History of systemic diseases affecting dental development.

研究实施时间:

Study execute time:

From 2026-07-06 00:00:00 To 2027-07-06 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-07-15 00:00:00 To 2027-03-15 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

300

Group:

Observation 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):

广东 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学附属口腔医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital of Stomatology, SunYat-sen University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

根据左下颌磨牙的CBCT影像推断年龄的准确性

指标类型:

主要指标

Outcome:

Accuracy of age estimation based on CBCT images of left mandibular molars

Type:

Primary indicator

测量时间点:

测量方法:

使用准确率、精确率、曲线下面积、平均绝对误差等来评价年龄推断模型的性能。

Measure time point of outcome:

None

Measure method:

Evaluate the performance of the age estimation model using metrics such as accuracy, precision, area under the curve, and mean absolute error.

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 10 years
最大 Max age 18 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:

使用Excel电子表格进行数据采集及管理

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

Using Excel spreadsheets for data collection and management

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2026-05-29 14:14:53