ChiCTR2600125436 版本V1.0 版本创建时间2026/05/27 09:33:11 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：

 ChiCTR2600125436 

最近更新日期：

Date of Last Refreshed on：

 2026-05-27 09:32:59 

注册时间：

Date of Registration：

 2026-05-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

主动法和被动法自我菌斑控制比较研究

Public title：

A Comparative Study of Active and Passive Methods for Dental Plaque Self-Control

注册题目简写：

English Acronym：

研究课题的正式科学名称：

主动法和被动法自我菌斑控制比较研究

Scientific title：

A Comparative Study of Active and Passive Methods for Dental Plaque Self-Control

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：

王兆伟 

研究负责人：

王兆伟 

Applicant：

Wang Zhaowei 

Study leader：

Wang Zhaowei 

申请注册联系人电话：

Applicant telephone：

 +86 10 57992030

研究负责人电话：

Study leader's
telephone：

+86 10 57992030

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：

 970611592@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 970611592@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：

北京市丰台区樊家村路9号院

研究负责人通讯地址：

北京市丰台区樊家村路9号院

Applicant address：

No. 9, Fanjia Village Road, Fengtai District, Beijing

Study leader's address：

No. 9, Fanjia Village Road, Fengtai District, Beijing

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-2026-22

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：

 2026-04-13 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：

北京市丰台区樊家村路9号院

Contact Address of the ethic committee：

No. 9, Fanjia Village Road, Fengtai District, Beijing

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：

北京市丰台区樊家村路9号院

Primary sponsor's address：

No. 9, Fanjia Village Road, Fengtai District, Beijing

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

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：

北京市丰台区樊家村路9号院

Institution
hospital：

Beijing Stomatological Hospital , Capital Medical University

Address：

No. 9, Fanjia Village Road, Fengtai District, Beijing

经费或物资来源：

首都医科大学附属北京口腔医院创新基金孵化专项

Source(s) of funding：

Innovative Fund Incubation Project of Beijing Stomatological Hospital Affiliated to Capital Medical

研究疾病：

牙龈炎；牙周炎  

Target disease：

Gingivitis;periodontitis

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：

随机交叉对照 

Study design：

Cross-over 

研究目的：

探索评估患者菌斑控制效果的方法，比较主动法和被动法（每天晚上睡前刷牙至少3分钟运用所学到的正确刷牙方法科学有效刷牙，直至刷牙干净，同时录制刷牙视频发送给项目组成员以接受个性化指导，例如指出正确的刷牙方法、纠正错误的刷牙方法和刷牙时长等，通过医务人员根据视频对受试者进行被动评估和改进，即被动法。需要受试者2-3天/周在睡前刷牙前先用清水漱口，用菌斑指示剂将牙齿染色（用小棉球蘸取菌斑指示剂药液，涂于每个指数牙的牙面上，再次漱口后，牙面被染色的区域，即是附着的菌斑），并用学习到的方法科学有效刷牙，直至将牙面上所有指示剂清除干净，使受试者可以对菌斑控制实现自我评价和主动改进，即主动法。）干预措施对自我菌斑控制的效果，为改善患者自我菌斑控制效果提供依据方法。  

Objectives of Study：

To explore methods for evaluating the effectiveness of patients' plaque control, and to compare the active method and the passive method (brushing teeth for at least 3 minutes every night before going to bed, using the correct brushing method learned scientifically and effectively to brush teeth until they are clean. At the same time, record the brushing video and send it to the project team members for personalized guidance, such as pointing out the correct brushing method, correcting incorrect brushing methods, and the duration of brushing, etc. Through medical staff's passive assessment and improvement based on the video, the passive method is adopted. The subjects need to rinse their mouths with water 2-3 times a week before brushing teeth, stain the teeth with a plaque indicator (using a small cotton ball to dip the plaque indicator solution and apply it to the surface of each index tooth, rinse the mouth again, and the stained area on the tooth surface is the attached plaque), and brush teeth scientifically and effectively using the learned method until all the indicators on the tooth surface are removed, so that the subjects can self-evaluate and actively improve their plaque control, which is the active method). To evaluate the effect of the intervention measures on self-plaque control, and provide a basis for improving the self-plaque control effect of patients.

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.年龄在18-60岁，性别不限，具有一定的理解能力和生活自理能力，天然牙总数>=15颗； 2.经确诊为牙周组织炎症性疾病，并行全口龈上洁治术、龈上喷砂和抛光治疗，接受常规口腔卫生宣教的患者； 3.术后即刻通过菌斑指示剂检查清除牙石和菌斑情况并要求指数牙的菌斑指数为0（按照1959年Ramfjord 提出的方法，只检查指定的六颗牙，即16、21、24、36、41、44，称为Ramfjord指数牙。）；且指数牙位有天然牙的存在；指数牙牙齿颈部无龋坏、无修复体修复； 4.自我菌斑控制差且自愿学习口腔维护方法。

Inclusion criteria

1. Age range: 18 - 60 years old. Gender not restricted. Possess certain comprehension ability and self-care ability in daily life. Total number of natural teeth >= 15; 2. Patients diagnosed with periodontal tissue inflammatory diseases and who have undergone full-mouth supra-gingival scaling, supra-gingival brushing and polishing treatment, and have received routine oral hygiene education; 3. Immediately after the surgery, through plaque indicator examination, check the removal of tartar and plaque, and require the plaque index of index teeth to be 0 (According to the method proposed by Ramfjord in 1959, only the specified six teeth are checked, namely 16, 21, 24, 36, 41, 44, which are called Ramfjord index teeth.) ; And there are natural teeth present in the index teeth; the tooth necks of the index teeth are free from caries and have no restorations. 4. Poor self-protection against plaque and willing to learn oral maintenance methods.

排除标准：

1.沟通障碍； 2.精神及智力障碍； 3.患有严重全身性系统性疾病； 4.对菌斑指示剂过敏； 5.妊娠或哺乳期女性。

Exclusion criteria：

1. Communication barriers; 2. Mental and intellectual disabilities; 3. Suffering from severe systemic diseases; 4. Allergic to plaque indicators; 5. Pregnant or lactating women.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-27 00:00:00 至 To 2028-12-31 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 75

Group：

Group A

Sample size：

干预措施：

采用先在第二周“被动法”再第三周“主动法”控制菌斑，每周对受试者菌斑指数和牙龈指数进行采集和比较，观察期为三周

干预措施代码：

Intervention：

The plaque was controlled first using the "passive method" in the second week and then the "active method" in the third week. The plaque index and gingival index of the subjects were collected and compared every week, and the observation period was three weeks.

Intervention code：

组别：

B组

样本量：

 75

Group：

Group B

Sample size：

干预措施：

采用先在第二周“主动法”再第三周“被动法”控制菌斑，每周对受试者菌斑指数和牙龈指数进行采集和比较，观察期为三周

干预措施代码：

Intervention：

The plaque was controlled first by the "active method" in the second week and then by the "passive method" in the third week. The plaque index and gingival index of the subjects were collected and compared every week, and the observation period was three weeks.

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 

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：

菌斑指数

指标类型：

主要指标

Outcome：

Plaque index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

牙龈指数

指标类型：

主要指标

Outcome：

Gingival index

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：

无

组织：

Sample Name：

None

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 18 岁 years
最大 Max age 60 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）：

由王兆伟采用分层随机分组方法，根据性别（男/女）、牙周组织炎症性疾病的严重程度（牙龈炎/牙周炎）为分层因素，所以可以分为女性牙龈炎、女性牙周炎、男性牙龈炎、男性牙周炎四类受试者，每类受试者编号为奇数分入A组（先被动法干预刷牙再主动法干预刷牙），偶数分入B组（先主动法干预刷牙再被动法干预刷牙）。

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

Wang Zhaowei used the stratified random grouping method. Based on the factors of gender (male/female) and the severity of periodontal tissue inflammatory diseases (gingivitis/dental periodontitis), the subjects could be divided into four groups: female gingivitis, female periodontitis, male gingivitis, and male periodontitis. Each group was numbered with odd numbers and assigned to group A (first passive method intervention for brushing teeth followed by active method intervention for brushing teeth), and even numbers were assigned to group B (first active method intervention for brushing teeth followed by passive method intervention for brushing teeth).

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：

对评估者隐藏分组

Blinding：

Hide the groups from the evaluators

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）：

无

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：

CRF

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-05-27 09:32:59