ChiCTR2600125747 版本V1.0 版本创建时间2026/05/30 17:39:14 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：

 ChiCTR2600125747 

最近更新日期：

Date of Last Refreshed on：

 2026-05-30 17:39:06 

注册时间：

Date of Registration：

 2026-05-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于行为科学的成人牙周病防治护理干预体系构建与效果评价

Public title：

Development and Effectiveness Evaluation of a Behavioral Science-Based Nursing Intervention System for Adult Periodontal Disease Prevention and Control

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于行为科学的成人牙周病防治护理干预体系构建与效果评价

Scientific title：

Development and Effectiveness Evaluation of a Behavioral Science-Based Nursing Intervention System for Adult Periodontal Disease Prevention and 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：

吉莎莎 

研究负责人：

吉莎莎 

Applicant：

JiShasha 

Study leader：

Jishasha 

申请注册联系人电话：

Applicant telephone：

 +86 511 8891 5903

研究负责人电话：

Study leader's
telephone：

+86 511 8891 5903

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：

 582500656@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 582500656@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：

江苏省镇江市电力路8号

研究负责人通讯地址：

江苏省镇江市电力路8号

Applicant address：

8 Dianli road, Zhenjiang, Jiangsu

Study leader's address：

8 Dianli road, Zhenjiang, Jiangsu

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：

镇江市第一人民医院

Applicant's institution：

Zhenjiang First People’s Hospital

研究负责人所在单位：

镇江市第一人民医院

Affiliation of the Leader：

Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu 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：

 [2026]KY064

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：

镇江市第一人民医院伦理委员会

Name of the ethic committee：

Ethics Committee of Affiliated People's Hospital of Jiangsu University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-04-30 00:00:00

伦理委员会联系人：

闻向梅

Contact Name of the ethic committee：

Wen XiangMei

伦理委员会联系地址：

江苏省镇江市电力路8号

Contact Address of the ethic committee：

8 Dianli road, Zhenjiang, Jiangsu

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 511 8891 7729

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 wenxiangmei@126.com

研究实施负责（组长）单位：

镇江市第一人民医院

Primary sponsor：

Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)

研究实施负责（组长）单位地址：

江苏省镇江市电力路8号

Primary sponsor's address：

8 Dianli road, Zhenjiang, Jiangsu

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

镇江市第一人民医院

具体地址：

江苏省镇江市电力路8号

Institution
hospital：

Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)

Address：

8 Dianli road, Zhenjiang, Jiangsu

经费或物资来源：

基于行为科学的成人牙周病防治护理干预体系构建与效果评价

Source(s) of funding：

Development and Effectiveness Evaluation of a Behavioral Science-Based Nursing Intervention System f

研究疾病：

本研究针对成人牙周病患者，主要为牙龈炎及牙周炎人群。临床表现可包括牙龈出血、牙龈红肿、口腔异味、菌斑及牙石堆积、牙周袋形成、牙龈退缩、附着丧失、牙齿松动及咀嚼不适等。  

Target disease：

This study targets adult patients with periodontal disease, mainly including those with gingivitis and periodontitis. Clinical manifestations may include gingival bleeding, gingival redness and swelling, oral malodor, plaque and calculus accumulation, periodontal pocket formation, gingival recession, attachment loss, tooth mobility, and discomfort during chewing.

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：

本研究旨在评价针对成人牙周病患者实施护理干预的临床应用效果，观察该干预措施在改善患者口腔健康行为、提高治疗依从性及促进牙周健康管理方面的作用，为构建规范、可操作的成人牙周病护理干预模式提供依据。 具体目的如下： 1.评价护理干预对成人牙周病患者口腔健康知识掌握情况及健康行为改变的影响。 2.评价护理干预对患者治疗配合度、复诊依从性及持续口腔卫生维护执行情况的影响。 3.观察护理干预对患者相关牙周临床结局指标改善情况的影响。 为成人牙周病患者护理干预措施的进一步规范化、标准化及临床推广提供参考依据。  

Objectives of Study：

This study aims to evaluate the clinical application effect of nursing intervention for adult patients with periodontal disease, and to observe the role of this intervention in improving oral health behaviors, enhancing treatment adherence, and promoting periodontal health management, so as to provide a basis for constructing a standardized and operable nursing intervention model for adult periodontal disease.The specific objectives are as follows:To evaluate the effect of nursing intervention on oral health knowledge and health behavior change in adult patients with periodontal disease.To evaluate the effect of nursing intervention on patients’ treatment cooperation, follow-up adherence, and maintenance of continuous oral hygiene.To observe the effect of nursing intervention on the improvement of periodontal clinical outcome indicators in 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18～60周岁，男女不限。
2.在本院口腔科就诊，经临床检查诊断为牙周病患者。
3.牙周检查提示存在以下一项或多项表现： a）牙龈红肿、出血； b）探诊出血阳性； c）牙周袋形成； d）临床附着丧失； e）X线片提示牙槽骨吸收。
4.受试者目前拟接受或已进入规范牙周基础治疗阶段，适合纳入护理干预研究。
5.无明显认知、交流障碍，能够理解研究内容并配合完成健康教育、行为指导和随访观察。
6.自愿参加本研究，并签署知情同意书。

Inclusion criteria

1.Aged 18 to 60 years, with no restriction on sex.
2.Patients attending the Department of Stomatology of this hospital and clinically diagnosed with periodontal disease.
3.Periodontal examination indicates one or more of the following manifestations: a) gingival redness, swelling, and bleeding; b) positive bleeding on probing; c) periodontal pocket formation; d) clinical attachment loss; e) alveolar bone resorption shown on X-ray examination.
4.Participants are currently planned to receive or have already entered the stage of standardized basic periodontal treatment, and are suitable for inclusion in the nursing intervention study.
5.Participants have no obvious cognitive or communication impairment, are able to understand the study content, and can cooperate with health education, behavioral guidance, and follow-up observation.
6.Voluntarily agree to participate in this study and sign the informed consent form.

排除标准：

1.合并严重心、脑、肝、肾等重要脏器疾病，不能耐受本研究相关检查或干预者。
2.合并严重精神障碍、认知功能障碍或沟通障碍，无法配合完成研究者。
3.合并其他严重口腔疾病或需优先进行其他专科治疗，影响本研究观察结果者。
4.近3个月内接受过系统牙周治疗或参加过类似干预研究者。
5.妊娠期或哺乳期女性（如标书中未特殊纳入，可列入排除标准）。
6.研究者判断不适合参加本研究者。
7.不愿签署知情同意书或依从性较差，预计无法完成随访者。

Exclusion criteria：

1.Patients with severe diseases of major organs, such as the heart, brain, liver, or kidneys, who cannot tolerate the examinations or interventions related to this study.
2.Patients with severe mental disorders, cognitive impairment, or communication disorders who are unable to cooperate with the study procedures.
3.Patients with other serious oral diseases or those requiring priority specialist treatment, which may affect the observation results of this study.
4.Patients who have received systematic periodontal treatment or participated in similar interventional studies within the past 3 months.
5.Pregnant or lactating women (may be listed as an exclusion criterion if not specifically included in the study protocol).
6.Patients deemed unsuitable for participation in this study by the investigators.
7.Patients who are unwilling to sign the informed consent form or have poor compliance and are expected to be unable to complete follow-up.

研究实施时间：

Study execute time：

从 From 2026-05-02 00:00:00至 To 2029-05-02 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-06-01 00:00:00 至 To 2029-05-02 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 38

Group：

Control group

Sample size：

干预措施：

对照组：常规护理

干预措施代码：

Intervention：

Control group: routine care

Intervention code：

组别：

干预组

样本量：

 38

Group：

Intervention group

Sample size：

干预措施：

干预组：牙周病护理干预

干预措施代码：

Intervention：

Intervention group: periodontal nursing intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 镇江市第一人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Zhenjiang First People's Hospital (Affiliated People’s Hospital of Jiangsu University)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

牙龈出血率（BOP）变化

指标类型：

次要指标

Outcome：

Bleeding on Probing (BOP)

Type：

Secondary indicator

测量时间点：

干预前、干预结束后、必要时随访期

测量方法：

采用六点法记录全口探诊出血位点百分比

Measure time point of outcome：

Before the intervention, after the completion of the intervention, and during follow-up when necessa

Measure method：

Percentage of bleeding sites in the full mouth, recorded using a six-site-per-tooth probing method.

指标中文名：

口腔健康行为

指标类型：

主要指标

Outcome：

oral health behaviors

Type：

Primary indicator

测量时间点：

干预前、干预结束后、必要时随访期

测量方法：

通过问卷调查

Measure time point of outcome：

Before the intervention, after the completion of the intervention, and during follow-up when necessa

Measure method：

Through a questionnaire survey

指标中文名：

口腔健康素养

指标类型：

主要指标

Outcome：

Oral health literacy

Type：

Primary indicator

测量时间点：

干预前、干预结束后、必要时随访期

测量方法：

复诊及随访记录、口腔临床检查等方式，对患者口腔健康行为、治疗依从性、牙周健康知识及牙周临床指标进行测量和评价。

Measure time point of outcome：

Before the intervention, after the completion of the intervention, and during follow-up when necessa

Measure method：

Patients’ oral health behaviors, treatment adherence, periodontal health knowledge, and periodontal clinical indicators were measured and evaluated through follow-up visit and follow-up records, as well as oral clinical examinations.

指标中文名：

菌斑指数（PI）

指标类型：

次要指标

Outcome：

Plaque Index (PI)

Type：

Secondary indicator

测量时间点：

干预前、干预结束后、必要时随访期

测量方法：

评价口腔菌斑控制水平

Measure time point of outcome：

Before the intervention, after the completion of the intervention, and during follow-up when necessa

Measure method：

To assess the level of dental plaque control

指标中文名：

COM-B行为简表得分

指标类型：

次要指标

Outcome：

COM-B questionnaire score

Type：

Secondary indicator

测量时间点：

干预前、干预结束后、必要时随访期

测量方法：

评价能力、机会和动机变化

Measure time point of outcome：

Before the intervention, after the completion of the intervention, and during follow-up when necessa

Measure method：

To assess changes in capability, opportunity, and motivation

指标中文名：

复诊依从性

指标类型：

次要指标

Outcome：

Follow-up adherence

Type：

Secondary indicator

测量时间点：

干预前、干预结束后、必要时随访期

测量方法：

评价研究对象按计划复诊情况

Measure time point of outcome：

Before the intervention, after the completion of the intervention, and during follow-up when necessa

Measure method：

To assess whether participants returned for follow-up visits as scheduled

指标中文名：

OHIP-14量表得分

指标类型：

次要指标

Outcome：

Score on the Oral Health Impact Profile-14 (OHIP-14)

Type：

Secondary indicator

测量时间点：

干预前、干预结束后、必要时随访期

测量方法：

评价口腔健康相关生活质量变化

Measure time point of outcome：

Before the intervention, after the completion of the intervention, and during follow-up when necessa

Measure method：

To assess changes in oral health-related quality of life

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：

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）：

随机数列由独立研究人员采用简单随机方法生成，并通过不透明密封信封法实施分配。

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

The random allocation sequence was generated by an independent researcher using a simple randomization method and implemented through opaque sealed envelopes.

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）：

公开原始数据日期：相关论文正式发表后6个月 公开原始数据方式：在确保受试者隐私保护和数据安全的前提下，对去标识化后的部分原始数据实行有限共享。申请者需提出合理学术用途说明，经研究负责人审核批准后，通过电子方式定向提供。

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

Date of raw data disclosure: 6 months after the formal publication of the related paper.Method of raw data disclosure: Under the premise of ensuring participant privacy protection and data security, partially de-identified raw data will be made available through limited sharing. Applicants are required to provide a reasonable academic purpose statement, and the data will be provided in a targeted electronic form upon review and approval by the principal investigator.

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：

病例记录表（CRF）： 本研究采用统一设计的病例记录表收集研究数据，内容包括受试者一般资料、牙周临床检查结果、问卷调查资料、干预实施情况、治疗及复诊记录、随访资料等。病例记录表由经过统一培训的研究人员填写，完成后由专人审核并统一编号保存。 电子采集和管理系统： 病例记录表审核无误后，由授权研究人员录入电子数据采集和管理系统，并进行复核。电子系统采用账号和密码登录方式，设置分级访问权限，仅限授权人员使用。研究数据采用去标识化管理，定期备份，并进行数据核查和质量控制，以确保数据真实、准确、完整和可追溯，同时严格保护受试者隐私。

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

Case Report Form (CRF):A uniformly designed Case Report Form (CRF) will be used in this study to collect research data. The contents include participants’ general information, periodontal clinical examination results, questionnaire survey data, intervention implementation records, treatment and follow-up visit records, and follow-up data. The CRFs will be completed by uniformly trained research personnel, reviewed by designated staff after completion, and stored with unified numbering.Electronic Data Capture and Management System:After the CRFs are reviewed and confirmed to be accurate, authorized research personnel will enter the data into the electronic data capture and management system and conduct verification. The electronic system will use account-and-password login with hierarchical access control, and only authorized personnel will be allowed to use it. Research data will be managed in a de-identified manner, regularly backed up, and subject to data verification and quality control to ensure authenticity, accuracy, completeness, and traceability, while strictly protecting participants’ privacy.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-05-30 17:39:06