ChiCTR2400094908 版本V1.0 版本创建时间2024/12/30 15:38:11 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：

 ChiCTR2400094908 

最近更新日期：

Date of Last Refreshed on：

 2024-12-30 15:37:43 

注册时间：

Date of Registration：

 2024-12-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

后生元对慢性牙周炎的辅助治疗效果的评价

Public title：

Evaluation of the Adjuvant Therapeutic Effect of Postbiotics on Chronic Periodontitis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

后生元对慢性牙周炎的辅助治疗效果的评价

Scientific title：

Evaluation of the Adjuvant Therapeutic Effect of Postbiotics on Chronic Periodontitis

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：

熊文杰 

研究负责人：

杨娟霞 

Applicant：

Xiong Wenjie 

Study leader：

Yang Juanxia 

申请注册联系人电话：

Applicant telephone：

 +86 18255720629

研究负责人电话：

Study leader's
telephone：

+86 15970497048

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：

 wenjiex333@163.com

研究负责人电子邮件：

Study leader's E-mail：

 417762412@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：

南昌大学转化医学研究院

研究负责人通讯地址：

中国江西省南昌市福州路49号

Applicant address：

Institute of Translational Medicine, Nanchang University

Study leader's address：

No.49, Fuzhou Road, Nanchang City, Jiangxi Province, 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：

南昌大学转化医学研究院

Applicant's institution：

Institute of Translational Medicine, Nanchang University

研究负责人所在单位：

南昌大学附属口腔医院

Affiliation of the Leader：

Affiliated Stomatological Hospital of Nanchang 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：

 口医伦审字2024第(033)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：

南昌大学附属口腔医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Stomatology Hospital Affiliated to Nanchang University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-12-10 00:00:00

伦理委员会联系人：

曾艺旋

Contact Name of the ethic committee：

Ceng Yixuan

伦理委员会联系地址：

中国江西省南昌市福州路49号

Contact Address of the ethic committee：

No.49, Fuzhou Road, Nanchang City, Jiangxi Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 791 86363326

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 719294644@qq.com

研究实施负责（组长）单位：

南昌大学附属口腔医院

Primary sponsor：

Affiliated Stomatological Hospital of Nanchang University

研究实施负责（组长）单位地址：

中国江西省南昌市福州路49号

Primary sponsor's address：

No.49, Fuzhou Road, Nanchang City, Jiangxi Province, 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)：

江西

市(区县)：

Country：

China

Province：

Jiangxi

City：

单位(医院)：

南昌大学附属口腔医院

具体地址：

中国江西省南昌市福州路49号

Institution
hospital：

Affiliated Stomatological Hospital of Nanchang University

Address：

No.49, Fuzhou Road, Nanchang City, Jiangxi Province, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

self-funded

研究疾病：

慢性牙周炎  

Target disease：

Chronic periodontitis (CP)

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：

本次研究通过在临床上探究后生元对CP的治疗作用。旨在阐明后生元对慢性牙周炎的辅助改善效果，从而减少慢性牙周炎复发，改善抗生素耐药现象，为患者提供更为更方便有效、副作用更小且成本更低的治疗方法提供一些新思路。  

Objectives of Study：

This study aims to investigate the therapeutic effect of extracellular vesicles on CP in clinical practice. The aim is to elucidate the auxiliary improvement effect of epigenetics on chronic periodontitis, thereby reducing the recurrence of chronic periodontitis, improving antibiotic resistance, and providing patients with more convenient, effective, less side effects, and lower cost treatment methods. This provides some new ideas.

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.符合慢性牙周炎诊断标准：PD≥4mm、CAL≥2mm、BOP阳性；
2.年龄18-60岁，男女不限；
3.口腔中存留牙≥20个；
4.近期未接受系统牙周治疗；
5.临床资料完整，无已知食物过敏或不耐受，体检合格；
6.认知功能正常，依从性较好，充分了解本试验，自愿签署知情同意书；

Inclusion criteria

1. Conforming to the Diagnostic Criteria for Chronic Periodontitis: A probing depth (PD) of >=4mm, clinical attachment loss (CAL) of >=2mm, and a positive result for bleeding on probing (BOP). 2. Individuals aged 18 to 60 years inclusive, of either sex. 3. With a minimum of twenty natural teeth retained in the oral cavity. 4. Having not undergone any recent comprehensive periodontal therapy; 5. The clinical records are comprehensive and intact, with no reported instances of food allergies or intolerances, and the individual has passed the medical examination with satisfactory results. 6. Exhibiting normal cognitive functioning, demonstrating robust adherence, possessing a comprehensive understanding of the trial, and voluntarily executing the informed consent form.

排除标准：

1.合并恶性肿瘤、自身免疫性疾病、血液系统疾病及肝肾功能不全； 2.患高血压、心脏病、糖尿病等全身性疾病； 3.1个月内接受抗生素治疗或在研究期间需要服用抗生素，在过去30天内参加过任何临床研究； 4.妊娠和哺乳期妇女； 5.咬合关系不良或有咬合创伤；

Exclusion criteria：

1.Coexisting with malignant neoplasms, autoimmune disorders, hematological conditions, and compromised hepatic and renal functionalities.
2.Afflicted with systemic conditions including hypertension, cardiovascular disease, and diabetes mellitus, among others.
3.Having undergone antibiotic therapy within the preceding month or with a necessity for antibiotic administration during the course of the study, and having participated in any clinical trials within the last 30 days.
4.Female individuals who are in the stages of gestation and lactation;
5.Presenting with malocclusion or suffering from occlusal trauma.

研究实施时间：

Study execute time：

从 From 2024-12-01 00:00:00至 To 2027-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-01-01 00:00:00 至 To 2027-12-01 00:00:00

干预措施：

Interventions：

组别：

牙周基础治疗+安慰剂组

样本量：

 50

Group：

Periodontal Basic Therapy Augmented with a Placebo Control Group

Sample size：

干预措施：

早晚刷牙后使用安慰剂漱口

干预措施代码：

Intervention：

After brushing teeth in the morning and evening, rinse the mouth with a placebo solution.

Intervention code：

组别：

牙周基础治疗+益生菌漱口水组

样本量：

 50

Group：

Periodontal Basic Therapy Coupled with Probiotic Mouthwash Group

Sample size：

干预措施：

早晚刷牙后使用含后生元漱口水漱口

干预措施代码：

Intervention：

After completing dental cleansing in the morning and evening, utilize a postbiotic-infused oral rinsing solution for mouthwash.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江西 

市(区县)：

  

Country：

China

Province：

Jiangxi

City：

单位(医院)：

 南昌大学附属口腔医院 

单位级别：

 三级甲等 

Institution
hospital：

Affiliated Stomatological Hospital of Nanchang University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

探诊深度

指标类型：

主要指标

Outcome：

Probing Depth(PD)

Type：

Primary indicator

测量时间点：

牙周基础治疗前以及治疗一月后

测量方法：

通过使用探针测量边缘牙龈到上皮附着区的距离来评估探诊袋深度，这取决于所观察到的龈沟的变化

Measure time point of outcome：

Prior to Initiation of Basic Periodontal Therapy and One Month Following Treatment

Measure method：

The probing pocket depth is assessed by measuring the distance from the marginal gingiva to the epithelial attachment zone using a probe, which is contingent upon the observed changes in the gingival sulcus.

指标中文名：

牙龈指数

指标类型：

次要指标

Outcome：

Gingival Index

Type：

Secondary indicator

测量时间点：

牙周基础治疗前以及治疗一月后

测量方法：

在近端、远端、颊侧和舌侧部位进行评价，每个部位被分配0-3分：0 =健康牙龈; 1 =牙龈炎伴轻微颜色变化和轻微肿胀，但无轻度刺激出血; 2 =牙龈炎伴轻度刺激发红、肿胀和出血; 3 =晚期炎症，伴有明显红肿，可能出现溃疡和自然出血。用每个牙面的平均值计算每个受试者的总PI评分

Measure time point of outcome：

Prior to Initiation of Basic Periodontal Therapy and One Month Following Treatment

Measure method：

Evaluations were conducted at the proximal, distal, buccal, and lingual sites, with each site being assigned a score of 0-3: 0 = healthy gingiva; 1 = gingivitis with mild color change and swelling but no bleeding upon mild stimulation; 2 = gingivitis with mild stimulation-induced redness, swelling, and bleeding; 3 = advanced inflammation with pronounced redness and swelling, potentially accompanied by ulceration and spontaneous bleeding. The total Plaque Index (PI) score for each subject was cal

指标中文名：

临床附着水平

指标类型：

主要指标

Outcome：

Clinical Attachment Level (CAL)

Type：

Primary indicator

测量时间点：

牙周基础治疗前以及治疗一月后

测量方法：

袋底至釉牙骨质界的距离，临床也称附着水平。探针测量PD退出时，确定釉-牙骨质位并获取釉-牙骨质界至龈缘的间距，PD减去此间距即CAL值

Measure time point of outcome：

Prior to Initiation of Basic Periodontal Therapy and One Month Following Treatment

Measure method：

The distance from the pocket bottom to the cemento-enamel junction (CEJ), clinically referred to as the Clinical Attachment Level (CAL), is measured. Upon withdrawal of the probe used for measuring the probing depth (PD), the cemento-enamel position is identified, and the distance from the CEJ to the gingival margin is obtained. The CAL value is calculated by subtracting this distance from the PD.

指标中文名：

探诊出血

指标类型：

次要指标

Outcome：

Bleeding on Probing (BOP)

Type：

Secondary indicator

测量时间点：

牙周基础治疗前以及治疗一月后

测量方法：

用于GI评价的标准应用于牙齿和牙齿表面以评估BOP。龈沟底部出血的存在表示为(+)，而其不存在表示为(-)。计算出血发生率（%BOP）

Measure time point of outcome：

Prior to Initiation of Basic Periodontal Therapy and One Month Following Treatment

Measure method：

The criteria utilized for gastrointestinal (GI) evaluation are applied to teeth and tooth surfaces to assess Bleeding on Probing (BOP). The presence of bleeding at the base of the gingival sulcus is denoted as (+), while its absence is denoted as (-). The incidence of bleeding (%BOP) is calculated.

指标中文名：

菌斑指数

指标类型：

次要指标

Outcome：

Plaque Index

Type：

Secondary indicator

测量时间点：

牙周基础治疗前以及治疗一月后

测量方法：

使用Loe和Silness PI技术，用红色着色剂对每个牙齿表面进行着色，并将牙齿表面分为两部分（咬合面和牙龈面），以测量牙菌斑积聚和牙龈缘厚度。评价标准为：0=牙面无菌斑；1=牙颈部龈缘处有散在的点状菌斑；2=牙颈部连续窄带状菌斑宽度不超过 1mm；3=牙颈部菌斑覆盖面积超过 1mm，但少于牙面 1/3；4=菌斑覆盖面积至少占牙面 1/3，但不超过 2/3；5=菌斑覆盖面积占牙面 2/3 或以上

Measure time point of outcome：

Prior to Initiation of Basic Periodontal Therapy and One Month Following Treatment

Measure method：

Utilizing the Loe and Silness Plaque Index (PI) technique, each tooth surface was stained with a red dye and divided into two parts (occlusal and gingival surfaces) to measure plaque accumulation and gingival margin thickness. The evaluation criteria were as follows: 0 = no plaque on the tooth surface; 1 = scattered spotty plaque at the gingival margin of the cervical region; 2 = a continuous narrow band of plaque not exceeding 1mm in width at the cervical region; 3 = plaque covering more than 1

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

唾液

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

龈沟液

组织：

Sample Name：

Gingival Crevicular Fluid (GCF)

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation 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 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）：

按预先计算好的样本含量（100例），由专人（不参与纳入受试者）在随机数字表中选第三行、第三列的数字，从此数开始按从左往右间隔一个数的规则取数，上一行结束直接转到间隔一行的数，依次取数；对于不在01-100的数或者已经被抽取的数舍去，直到取出100个数；取出的前50个数所对应的编号组成第一组（A组），后50个数组成第二组（B组）

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

Based on the pre-calculated sample size (100 cases), a dedicated individual (who is not involved in participant recruitment) selected a number from the third row and third column of a random number table. From this number onwards, numbers were selected following the rule of skipping one number from left to right. Upon reaching the end of a row, the selection continued directly to the number in the row that is one interval above the current position, proceeding sequentially in this manner. Numbers outside the range of 01-100 or those already drawn were discarded until a total of 100 numbers were obtained. The first 50 numbers drawn constituted Group A (the first group), while the subsequent 50 numbers formed Group B (the second group).

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：

双盲，对受试者和临床医师实施盲法。

Blinding：

Double blinding, implementing blinding for both subjects and clinical physicians.

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 share

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：

未说明

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-12-30 15:37:43