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The effects of the antimicrobial peptide Nal-P-113 on oral bacteria and the periodontal index
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注册号:

Registration number:

ChiCTR-OIC-16010250 

最近更新日期:

Date of Last Refreshed on:

2016-12-25 

注册时间:

Date of Registration:

2016-12-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

抗菌肽Nal-P-113对口腔细菌和牙周指标的影响 

Public title:

The effects of the antimicrobial peptide Nal-P-113 on oral bacteria and the periodontal index 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

抗菌肽在牙周炎防治中的应用初探 

Scientific title:

Application of antibacterial peptide in prevention and treatment of periodontitis 

研究课题代号(代码):

Study subject ID:

沈阳市科技计划项目(F13-318-28) 

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:

林莉 

研究负责人:

林莉 

Applicant:

Lin Li 

Study leader:

Lin Li 

申请注册联系人电话:

Applicant telephone:

+86 18040221902 

研究负责人电话:

Study leader's telephone:

+86 18040221902 

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:

linli_74k@yahoo.com 

研究负责人电子邮件:

Study leader's E-mail:

linli_74k@yahoo.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:

辽宁省沈阳市南京北街117号 

研究负责人通讯地址:

辽宁省沈阳市南京北街117号 

Applicant address:

117 Nanjing Street, Heping District, Shenyang 

Study leader's address:

117 Nanjing Street, Heping District, Shenyang 

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:

中国医科大学附属口腔医院 

Applicant's institution:

School of Stomatology, China 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:

2014-9 

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:

中国医科大学伦理委员会 

Name of the ethic committee:

medical ethics committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-01-19 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

中国医科大学附属口腔医院 

Primary sponsor:

School of Stomatology, China Medical University 

研究实施负责(组长)单位地址:

辽宁省沈阳市南京北街117号 

Primary sponsor's address:

117 Nanjing Street, Heping District, Shenyang, 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):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属口腔医院

具体地址:

辽宁省沈阳市南京北街117号

Institution
hospital:

School of Stomatology, China Medical University

Address:

117 Nanjing Street, Heping District, Shenyang

经费或物资来源:

沈阳市科技计划项目(F13-318-28) 

Source(s) of funding:

Science and Technology Plan Project in Shenyang 

研究疾病:

慢性牙周病 

Target disease:

Periodontal disease 

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:

III期临床试验 

Study phase:

研究目的:

1. 探讨抗菌肽对牙菌斑形成的抑制作用及对牙周致病菌的抗菌作用 2. 探讨抗菌肽Nal-P-113对牙周临床指标的改善 

Objectives of Study:

1. In this study, we evaluated the effect of Nal-P-113 on oral bacteria and periodontal index; 2. detect the inhibitory effect of antimicrobial peptide Nal-P-113 to dental biofilm and the bactericidal action to periodontal pathogen. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1.牙周健康:牙龈色粉红,探诊无出血,龈沟深度 < 3 mm 2. 年龄20-35岁 3.知情同意 

Inclusion criteria

1. periodontal health: gingiva pink, without bleeding, periodontal depth < 3 mm; 2. aged between 20-35 years; 3. informed consent. 

排除标准:

1. 3个月内使用过抗生素 2. 口腔内有修复体或者佩戴正畸矫治器 3. 吸烟、饮酒的个体 4. 患有全身性疾病的个体 5. 妇女妊娠或哺乳期 

Exclusion criteria:

1. participants received antibiotics, mouthrinse, or antibiotic dentifrice or participated in other clinical study in the past three months; 2. with crowns or a fixed bridge or wear orthodontic treatments; 3. subjects smoke or drink; 4. participants have a history of systemic disease; 5. participants are pregnant or lactating. 

研究实施时间:

Study execute time:

From2012-10-01To 2014-08-20 

干预措施:

Interventions:

组别:

2组:实验组和对照组

样本量:

60

Group:

two group: experimental group and control group

Sample size:

干预措施:

抗菌肽Nal-P-113漱口水的应用

干预措施代码:

Intervention:

take Nal-P-113 mouthwash

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

辽宁 

市(区县):

沈阳 

Country:

China 

Province:

Liaoning 

City:

Shenyang 

单位(医院):

中国医科大学附属口腔医院 

单位级别:

三甲医院 

Institution
hospital:

School of Stomatology, China Medical University  

Level of the institution:

Tertiary A hospital 

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:

菌斑面积

指标类型:

主要指标 

Outcome:

plaque area

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

牙周袋深度

指标类型:

主要指标 

Outcome:

periodontal depth

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床附着丧失

指标类型:

主要指标 

Outcome:

clinical attachment loss

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

出血指数

指标类型:

主要指标 

Outcome:

blood 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:

菌斑内细菌种类含量

指标类型:

主要指标 

Outcome:

bacterial content of plaque

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:

牙菌斑

组织:

牙周袋内细菌

Sample Name:

plaque

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 35 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):

由第三方(即非实验人员和数据统计人员)

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

the third party (not experimenter or data statistics)

盲法:

Blinding:

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

通过ResMan提供原始数据查询

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

IPD will be public accessable via ResMan

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:

中国医科大学附属口腔医院

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

School of stomatology, China Medical University

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-12-25
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