ChiCTR2600124346 版本V1.0 版本创建时间2026/05/11 11:54:22 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600124346 

最近更新日期：

Date of Last Refreshed on：

 2026-05-11 11:54:11 

注册时间：

Date of Registration：

 2026-05-11 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

同源重组蛋白RAD54B促进牙髓干细胞增殖及成牙 本质向分化参与牙髓损伤修复的机制研究

Public title：

The mechanism of homologous recombination protein RAD54B in regulating the proliferation and odontoblastic differentiation of dental pulp stem cells during dental pulp repair responses

注册题目简写：

English Acronym：

研究课题的正式科学名称：

同源重组蛋白RAD54B促进牙髓干细胞增殖及成牙本质向分化参与牙髓损伤修复的机制研究

Scientific title：

The mechanism of homologous recombination protein RAD54B in regulating the proliferation and odontoblastic differentiation of dental pulp stem cells during dental pulp repair responses

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：

黄佩 

研究负责人：

黄佩 

Applicant：

Huang Pei 

Study leader：

Huang Pei 

申请注册联系人电话：

Applicant telephone：

 +86 10 12345678

研究负责人电话：

Study leader's
telephone：

+86 15927543389

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：

 401571066@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 401571066@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：

中国北京市丰台区樊家村路9号

研究负责人通讯地址：

中国北京市丰台区樊家村路9号

Applicant address：

9 Fanjia Village Road, Fengtai District, Beijing, China

Study leader's address：

9 Fanjia Village Road, Fengtai 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：

首都医科大学附属北京口腔医院

Applicant's institution：

Beijing Stomatological Hospital, Capital Medical University

研究负责人所在单位：

首都医科大学附属北京口腔医院

Affiliation of the Leader：

Beijing Stomatological Hospital , Capital 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：

 CMUSH-IRB-KJ-PJ-2026-23

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：

首都医科大学附属北京口腔医院伦理委员会

Name of the ethic committee：

Institutional Review Board of Beijing Stomatological Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-17 00:00:00

伦理委员会联系人：

夏晓钰

Contact Name of the ethic committee：

Xia Xiaoyu

伦理委员会联系地址：

中国北京市丰台区樊家村路9号

Contact Address of the ethic committee：

9 Fanjia Village Road, Fengtai District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 57099307

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 18602615270@163.com

研究实施负责（组长）单位：

首都医科大学附属北京口腔医院

Primary sponsor：

Beijing Stomatological Hospital , Capital Medical University

研究实施负责（组长）单位地址：

中国北京市丰台区樊家村路9号

Primary sponsor's address：

9 Fanjia Village Road, Fengtai 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)：

首都医科大学附属北京口腔医院

具体地址：

中国北京市丰台区樊家村路9号

Institution
hospital：

Beijing Stomatological Hospital , Capital Medical University

Address：

9 Fanjia Village Road, Fengtai District, Beijing, China

经费或物资来源：

首都医科大学附属北京口腔医院青年科技创新人才培育计划（Ⅱ期）

Source(s) of funding：

Young Scientist Program of Beijing Stomatological Hospital, Capital Medical University

研究疾病：

龋病  

Target disease：

Dental caries

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：

队列研究 

Study design：

Cohort study 

研究目的：

1、收集口腔颌面外科门诊18-25岁患者健康、中龋及深龋第三磨牙离体牙样本，进行标准化处理，并检测不同牙髓状态组织样本中目的指标的表达水平及分布差异，为后续牙体牙髓DNA损伤修复相关基础研究提供可靠的人源样本及研究依据。 2、从收集获得的健康第三磨牙牙髓组织中分离培养原代牙髓干细胞，在体外对DNA损伤修复相关蛋白进行干预并实施诱导分化处理，检测并比较不同实验组细胞成牙向分化能力及目的指标表达水平、分布差异，为后续牙体牙髓相关基础研究和转化研究提供理论依据。  

Objectives of Study：

1. To extract third molar samples (healthy, intermediate caries, and deep caries) were collected from patients aged 18–25 years in the department of oral and maxillofacial surgery clinic and subject them to standardized processing. The expression levels and distribution differences of target factors in pulp tissue samples with different pulp states are detected, thereby providing reliable human-derived samples and a research basis for subsequent basic studies on DNA damage repair in dental hard tissues and pulp tissues. 2. Primary dental pulp stem cells are isolated and cultured from the pulp tissues of healthy third molars. DNA damage repair-related proteins were modulated and differentiation was induced. The odontogenic differentiation capacity, as well as the expression levels and distribution differences of target proteins, were detected and compared among different experimental groups, thus providing a theoretical basis for subsequent basic and translational research related to dental pulp and tooth structures.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄 18-25 岁，性别不限； 2.于我院口腔颌面外科门诊就诊，拟接受阻生智齿拔除术； 3.拟收集牙齿根据病史、口腔检查、影像学检查及牙髓活力测试明确分为健康组、中龋组或深龋组，牙髓组织的临床诊断与分组标准依据美国牙髓病学会（AAE）诊断标准（2009）严格评估（健康组：无临床症状，牙髓活力测试反应正常，根尖片显示根尖周组织无异常；中龋组：龋损达牙本质浅层，影像学显示病变扩展至牙本质外1/3，无自发痛史；深龋组：龋损近髓，影像学显示病变扩展至牙本质中1/3至内1/3，无露髓或剧烈疼痛史）； 4.无既往牙髓治疗史（盖髓术、牙髓切断术等）及根尖周病变；

Inclusion criteria

1.Aged 18–25 years old with no restriction on gender; 2.Outpatients presenting to the Department of Oral and Maxillofacial Surgery Clinic of our hospital and scheduled for impacted third molar extraction; 3.The enrolled teeth were strictly divided into the healthy group, intermediate caries group, and deep caries group based on medical history, oral examination, imaging examination, and pulp vitality test. The clinical diagnosis and grouping criteria of dental pulp tissues were evaluated in accordance with the 2009 diagnostic guidelines of the American Association of Endodontists (AAE). Health group: No clinical symptoms, normal response to pulp vitality test, and no periapical abnormalities observed on periapical radiographs; Intermediate caries group: Caries lesions involving the superficial layer of dentin, radiographic lesions extending to the outer one-third of the dentin, and no history of spontaneous pain; Deep caries group: Caries lesions close to the dental pulp, radiographic lesions extending to the middle and inner one-third of the dentin, with no history of pulp exposure or severe pain; 4.No previous history of endodontic treatment (e.g., pulp capping, pulpotomy) and no periapical lesions.

排除标准：

1.合并可能影响牙髓状态判断或组织状态的全身性疾病，如糖尿病、免疫系统疾病等； 2.长期服用可能影响牙髓状态的药物,如非甾体抗炎药、免疫抑制剂等； 3.存在牙周病变； 4.处于妊娠期或哺乳期等特殊生理状态； 5.存在精神或智力障碍等情况；

Exclusion criteria：

1.Patients complicated with systemic diseases that may interfere with the evaluation of pulp status and tissue conditions, such as diabetes, immune system diseases, and other related disorders; 2.Long-term administration of medications that may affect pulp status, including non-steroidal anti-inflammatory drugs, immunosuppressants, etc. 3.Presence of periodontal lesions; 4.Special physiological status such as pregnancy or lactation; 5.Presence of mental or intellectual disorders;

研究实施时间：

Study execute time：

从 From 2025-01-25 00:00:00至 To 2027-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-11 00:00:00 至 To 2027-07-31 00:00:00

干预措施：

Interventions：

组别：

中龋组

样本量：

 24

Group：

Intermediate caries

Sample size：

干预措施：

无

干预措施代码：

Intervention：

No intervention

Intervention code：

组别：

健康组

样本量：

 24

Group：

Healthy group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

No intervention

Intervention code：

组别：

深龋组

样本量：

 24

Group：

Deep caries group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

No intervention

Intervention code：

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)：

 首都医科大学附属北京口腔医院 

单位级别：

 三级甲等 

Institution
hospital：

Beijing Stomatological Hospital , Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

同源重组蛋白RAD54B及DNA损伤修复相关因子、成牙/骨相关因子及下游因子的表达

指标类型：

主要指标

Outcome：

Expression of homologous recombination protein RAD54B, DNA damage repair-related factors, odonto/osteogenic-related factors, and downstream factors

Type：

Primary indicator

测量时间点：

样本收集及处理后即刻

测量方法：

组织学（HE染色、Masson染色、TUNEL染色）和分子标志物（DSPP、DMP1、RAD54B、 a-SMA、Nestin等指标的免疫组化及荧光染色检测；流式细胞术、分子生物学手段（Western blot、RT-qPCR等），以及免疫荧光染色、碱性磷酸酶及茜素红染色等

Measure time point of outcome：

Immediately after pulp/cell sample collection and processing

Measure method：

Histological examinations including hematoxylin-eosin (HE) staining, Masson staining, and TUNEL staining; detection of molecular markers such as DSPP, DMP1, RAD54B, α-SMA, and Nestin via immunohistochemistry and immunofluorescence staining; flow cytometry; molecular biological techniques including Western blot and RT-qPCR; as well as immunofluorescence staining, alkaline phosphatase (ALP) staining, and Alizarin Red S staining.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

人牙髓组织

组织：

Sample Name：

Human dental pulp tissues

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction 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 岁 years
最大 Max age 25 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：

无

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）：

不共享

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

Not shared

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：

本研究设置病例报告表及样本登记表，表格内容与本研究方案保持一致，主要用于记录受试者基本信息、病史资料、口腔检查结果、影像学资料、牙髓活力测试结果、分组信息、离体牙样本采集信息、样本处理过程及后续组织学、细胞学和分子检测结果。临床采集数据和实验数据均及时、真实、准确、完整地记录于原始记录和病例报告表中，不得随意涂改、伪造或遗漏；如确需更改，应保留修改痕迹并注明修改日期、原因及修改人。本研究同时建立电子数据文件，用于录入和整理受试者筛选资料、样本编号信息及实验检测结果。电子数据由授权研究人员录入并定期备份，采用研究编号和样本编号进行管理，不直接使用受试者姓名等身份识别信息。电子数据存放于计算机中并限制访问权限，仅限项目负责人及经授权的研究人员查阅和使用。研究期间样本、资料和数据实行去标识化管理；研究结束后，相关资料和数据按医院及实验室管理制度保存，在规定保存期满后按要求处理。

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

Case report forms (CRFs) and sample registration forms were established in this study, with contents consistent with the research protocol. These forms were mainly used to record participants’ basic information, medical history, oral examination results, imaging data, pulp vitality test outcomes, grouping information, information of extracted tooth sample collection, sample processing procedures, and subsequent histological, cytological and molecular detection results. All clinically collected and experimental data were recorded timely, authentically, accurately and completely in the original records and CRFs. Random alteration, forgery or omission of data was not permitted. If modifications were absolutely necessary, the revision traces should be retained, along with clear annotation of the revision date, reason and operator. Electronic data files were simultaneously established for entry and sorting of participant screening information, sample coding data and experimental detection results. Electronic data were entered by authorized researchers and backed up regularly. All data were managed using research numbers and sample numbers without directly adopting identifiable personal information such as participants’ full names. Electronic data were stored in designated computers with restricted access permissions, and only the project principal and authorized researchers were allowed to review and use the data. During the research period, all samples, documents and data were managed in a de-identified manner. Upon study completion, relevant documents and data were preserved in accordance with the administrative regulations of the hospital and laboratory, and disposed of as required after the expiration of the specified retention period.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-05-11 11:54:11