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：	ChiCTR2500107951
最近更新日期： Date of Last Refreshed on：	2025-08-21 14:43:39
注册时间： Date of Registration：	2025-08-21 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	颊侧槽形微创去骨拔除下颌低位埋伏阻生牙的临床研究
Public title：	How to reduce periodontal damage to the second molar for low-impacted third molars extracted from the mandibular: a randomized clinical trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	颊侧槽形微创去骨拔除下颌低位埋伏阻生牙的临床研究
Scientific title：	How to reduce periodontal damage to the second molar for low-impacted third molars extracted from the mandibular: a randomized clinical trial
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：	黄伟	研究负责人：	黄伟
Applicant：	Wei Huang	Study leader：	Wei Huang
申请注册联系人电话： Applicant telephone：	+86 13709689196	研究负责人电话： Study leader's telephone：	+86 13709689196
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：	shend2024@163.com	研究负责人电子邮件： Study leader's E-mail：	hwdentist@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：	广东省珠海市香洲区康宁路79号	研究负责人通讯地址：	广东省珠海市香洲区康宁路79号
Applicant address：	No. 79, Kangning Road, Xiangzhou District, Zhuhai City, Guangdong Province	Study leader's address：	No. 79, Kangning Road, Xiangzhou District, Zhuhai City, Guangdong 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：	珠海市人民医院
Applicant's institution：	Zhuhai People's Hospital
研究负责人所在单位：	珠海市人民医院
Affiliation of the Leader：	Zhuhai People's Hospital

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：	（2024）伦审【研】第（25）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：	珠海市人民医院伦理委员会
Name of the ethic committee：	Ethics Committee of Zhuhai People's Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024-04-24 00:00:00
伦理委员会联系人：	温宇云
Contact Name of the ethic committee：	Wen Yuyun
伦理委员会联系地址：	广东省珠海市香洲区康宁路79号
Contact Address of the ethic committee：	No. 79, Kangning Road, Xiangzhou District, Zhuhai City, Guangdong Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 756 2158211	伦理委员会联系人邮箱： Contact email of the ethic committee：	963179547@qq.com

研究实施负责（组长）单位：

珠海市人民医院

Primary sponsor：

Zhuhai People's Hospital

研究实施负责（组长）单位地址：

广东省珠海市香洲区康宁路79号

Primary sponsor's address：

No. 79, Kangning Road, Xiangzhou District, Zhuhai City, Guangdong 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)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	珠海市人民医院	具体地址：	广东省珠海市香洲区康宁路79号
Institution hospital：	Zhuhai People's Hospital	Address：	No. 79, Kangning Road, Xiangzhou District, Zhuhai City, Guangdong Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

None

研究疾病：

下颌低位埋伏第三磨牙

Target disease：

Impactde mandibular third mola

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

为避免大范围颊侧去骨给第二磨牙牙周带来较大损伤，本研究拟采用颊侧槽形去骨拔除下颌低位埋伏阻生牙，并设计一双向性研究，比较颊侧槽形去骨和传统常规去骨方式去拔除低位阻生牙的损伤及术后恢复情况，验证此方法的临床效果。为下颌低位埋伏阻生第三磨牙的拔除提供一些新的思路。

Objectives of Study：

In order to avoid the large-scale buccal debridement to bring large damage to the periodontium of the second molar, the present study proposed to use buccal groove debridement to extract the mandibular low ambulatory third molar, and designed a bidirectional study to compare the damage and postoperative recovery between the buccal groove debridement and the conventional debridement to extract the low ambulatory third molar, and to validate the clinical effect of this method. It provides some new ideas for the extraction of mandibular low ambulatory third molars.

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）影像学检查提示下颌第三磨牙区有囊肿或其他牙源性病变；（2）局部组织近期疼痛或感染发作；（3）合并免疫抑制疾病，妊娠或哺乳期妇女，合并系统性疾病包括心血管疾病，糖尿病，高血压，甲亢，肝肾系统疾病或有其他拔牙禁忌；（4）张口度过小影响手术操作；（5）第三磨牙倒置阻生或位置过于偏向舌侧、近中、远中，过于低位等导致手术难度过大。

Exclusion criteria：

1. Imaging examinations suggesting cysts or other odontogenic lesions in the mandibular third molar region. 2.Recent pain or inflammation in local tissues. 3.Combination of immunosuppressive diseases, pregnant or breastfeeding women, combination of systemic diseases including cardiovascular disease, diabetes mellitus, hypertension, hyperthyroidism, hepatic and renal system diseases, or other contraindications to tooth extraction. 4.Excessive mouth opening to interfere with surgical operation. 5.Third molar Inverted and blocked or positioned too far to the lingual side, proximal centre, distal centre, too low, etc., which makes the operation too difficult.

研究实施时间：

Study execute time：

从 From 2021-11-01 00:00:00至 To 2025-06-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-04-27 00:00:00 至 To 2025-06-01 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	40
Group：	Control group	Sample size：	40
干预措施：	传统常规去骨方式去拔除低位阻生牙	干预措施代码：
Intervention：	Traditional conventional bone removal method to remove low impacted teeth	Intervention code：

组别：	试验组	样本量：	40
Group：	Experimental group	Sample size：	40
干预措施：	颊侧槽形去骨方式去拔除低位阻生牙	干预措施代码：
Intervention：	Buccal grooved bone removal method to remove the low impacted tooth	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	广东省	市(区县)：
Country：	China	Province：	Guangdong	City：
单位(医院)：	珠海市人民医院	单位级别：	三级甲等
Institution hospital：	Zhuhai People's Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	手术时间	指标类型：	次要指标
Outcome：	Operation time	Type：	Secondary indicator
测量时间点：	手术当天	测量方法：	记录从手术开始到手术结束的时间
Measure time point of outcome：	Surgical day	Measure method：	Record the time from the start of the procedure to the end of the procedure

指标中文名：	第二磨牙牙周探诊深度	指标类型：	主要指标
Outcome：	Periodontal condition of the second molar	Type：	Primary indicator
测量时间点：	术前、术后3个月、术后6个月	测量方法：	术前、术后 3 个月和 6 个月时，使用带刻度的钝尖牙周探针在远中颊角（DB）、远中舌角（DL）和远中轴中心点进行牙周探查，记录第二磨牙牙周探诊深度。
Measure time point of outcome：	Preoperative period and at three and six months postoperatively.	Measure method：	The depth of the second adjacent mandibular molar was recorded by periodontal probing at the distal mesiobuccal angle (DB), distal mesiolingual (DL), and distal mesiocentric points using a blunt-tipped periodontal probe with a graduated scale during the preoperative period and at three and six months postoperatively.

指标中文名：	疼痛	指标类型：	次要指标
Outcome：	Pain	Type：	Secondary indicator
测量时间点：	手术当天、术后第3天、术后第6天	测量方法：	术后疼痛采用视觉模拟量表（VAS）（Scott 和 Huskinsson，1976 年）进行评估，从无痛（0 分）到可想象的最剧烈疼痛（100 分）不等。从术后第 0 天到术后第 6 天（缝线拆除），患者每天在家中自行完成该量表。
Measure time point of outcome：	Surgical day and postoperative day 3 and day 6	Measure method：	Postoperative pain was assessed using the Visual Analogue Scale (VAS) (Scott and Huskinsson, 1976), ranging from no pain (0 points) to the most severe pain imaginable (100 points). The scale was completed daily at home by the patients themselves from postoperative day 0 to postoperative day 6, at which point the sutures were removed.

指标中文名：	张口度	指标类型：	次要指标
Outcome：	Changes in postoperative mouth opening	Type：	Secondary indicator
测量时间点：	术前、术后第3天、术后第6天	测量方法：	术前、术后第 3 天和第 6 天检查口腔张开是否受限。为排除患者之间每日最大张口大小的影响，使用直尺测量患者术前、术后第 3 天和术后第 6 天之间上下中切牙之间的最大张口距离，然后相减，得出患者第 3 天和第 6 天最大张口距离的缩小值作为评价指标。
Measure time point of outcome：	Preoperative periods and postoperative day 3 and postoperative day 6	Measure method：	Patients were instructed to return to the clinic on postoperative day 3 and postoperative day 6 to check for restrictions in the mouth opening. To exclude the influence of the maximum daily opening size between patients, the maximum opening distances between the upper and lower mesial incisors were measured using a ruler between the patient's preoperative day, postoperative day 3, and postoperative day 6, and subtracted to obtain the value of the reduction of the maximum opening distance of day

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	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：

结束

/Completed

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	35	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）：

研究者将符合纳入排除标准的既往资料编号，使用随机号码随机选取40名作为对照组。

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

Researchers assigned numbers to previously collected data that met the inclusion/exclusion criteria, and randomly selected 40 subjects as the control group using random numbers.

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：	开放标签，对评估者隐藏分组
Blinding：	Open-label study with blinded-evaluators

是否共享原始数据： IPD sharing	是Yes
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）：	ResMan,论文发表后一年内， 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)：	ResMan, within one year of publication, 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：	本研究所有数据均来源于HIS系统原始资料、口腔科CBCT影响学原始资料，且不涉及采集人体样本。所有记录中的数据均来源于HIS系统原始资料、口腔科CBCT影响学原始资料。本研究采用Microsoft Office办公软件进行数据录入，数据将保存在专用的电脑中记录保存。数据记录--手术时间、牙周情况，术后反应；影像学检查—CBCT、全景片等数据将按照国际通用的数据管理规范进行整理和清洗，保证数据的完整性、准确性和可重复性。数据将按照匿名化原则进行处理，保护患者的隐私和权益。数据将仅供本项目组成员使用。数据管理人员架构：黄伟、黄芋、黄山、张天姝、李绮岚质控机制：所有的临床研究人员均为参加过GCP培训并取得GCP证书人员。临床研究人员确保遵照程序保护受试者私密性。由项目管理者对数据进行内部审核确保质量。数据和文件储存于医院专用电脑，硬件支持有医院信息科提供。除非法律需要，受试者的个人信息将不会被泄露。研究中获得的关于受试者的个人身份信息将被加以编码匿名化处理，储存于医院专用载体并被严格保密，且仅用于本研究。研究组将采取措施保护受试者的个人信息，不会将能显示受试者身份信息的内容出现在任何研究文件、报告、发表的文章中。研究结束后受试者的数据不会被保留，研究结果包括实验室检查和其他结果将在不泄露受试者的身份信息的前提下因科学目的而发表。我们将在法律允许的范围内，尽一切努力保护受试者个人医疗资料的隐私
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	All data in this study were obtained from HIS system raw data, dental CBCT impactology raw data, and did not involve the collection of human samples. All the data in the records were obtained from HIS system raw data, CBCT impactology raw data in dentistry. Microsoft Office office software was used for data entry in this study and the data will be kept in a dedicated computer for record keeping. Data recording - surgery time, periodontal condition, postoperative response; imaging - CBCT, panoramic film, etc. Data will be collated and cleaned in accordance with internationally accepted data management norms to ensure completeness, accuracy and reproducibility. The data will be processed in accordance with the principle of anonymisation to protect patients' privacy and rights. The data will be used only by members of this project team. Data management staff structure: Wei Huang, Taro Huang, Shan Huang, Tianshu Zhang, Elaine Li Quality control mechanism: All clinical researchers are GCP trained and certified. Clinical researchers ensure that procedures are followed to protect subject privacy. Internal audits of the data were conducted by the project manager to ensure quality. Data and documents were stored on a dedicated hospital computer with hardware support provided by the hospital's information department. Subjects' personal information will not be disclosed unless required by law. Personally identifiable information about subjects obtained during the study will be coded and anonymised, stored on a dedicated hospital carrier and kept strictly confidential, and used only for this study. The research team will take steps to protect the subject's personal information and will not include any information that reveals the subject's identity in any research document, report, or published article. Subject data will not be retained after the completion of the study, and the results of the study, including laboratory tests and other results, will be published for scientific purposes without disclosing identifying information about the subjects. Every effort will be made to protect the privacy of the subject's personal medical information to the extent permitted by law.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-08-21 14:43:16