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龈下刮治根面平整联合表没食子儿茶素没食子酸酯 (EGCG)龈下冲洗对慢性牙周炎治疗效果的临床观察
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注册号:

Registration number:

ChiCTR2000029831 

最近更新日期:

Date of Last Refreshed on:

2020-02-15 

注册时间:

Date of Registration:

2020-02-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

龈下刮治根面平整联合表没食子儿茶素没食子酸酯 (EGCG)龈下冲洗对慢性牙周炎治疗效果的临床观察 

Public title:

The adjunctive use of (-)-epigallocatechin gallate (EGCG) subgingival irrigating solution with scaling and root planing in the management of chronic periodontitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

龈下刮治根面平整联合表没食子儿茶素没食子酸酯 (EGCG)龈下冲洗对慢性牙周炎治疗效果的临床观察 

Scientific title:

The adjunctive use of (-)-epigallocatechin gallate (EGCG) subgingival irrigating solution with scaling and root planing in the management of 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:

王延峰 

研究负责人:

栾庆先 

Applicant:

YANFENG WANG 

Study leader:

QINGXIAN LUAN 

申请注册联系人电话:

Applicant telephone:

+86 18001229690 

研究负责人电话:

Study leader's telephone:

+86 13651330496 

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:

kqnickwang@163.com 

研究负责人电子邮件:

Study leader's E-mail:

kqluanqx@126.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:

北京市海淀区中关村南大街22号 

研究负责人通讯地址:

北京市海淀区中关村南大街22号 

Applicant address:

22 Zhong-Guan-Cun Street South, Haidian District, Beijing, China 

Study leader's address:

22 Zhong-Guan-Cun Street South, Haidian District, Beijing, 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:

北京大学口腔医学院 

Applicant's institution:

School of Stomatology, Peking 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:

PKUSSIRB-201839128 

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:

北京大学口腔医院生物医学伦理委员会 

Name of the ethic committee:

IRB of Peking University Hospital of Stomatology 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-12 

伦理委员会联系人:

冯海兰 

Contact Name of the ethic committee:

HAILAN FENG 

伦理委员会联系地址:

北京市海淀区中关村南大街22号北京大学口腔医学院行政楼406 

Contact Address of the ethic committee:

406 Administrative Building, School of Stomatology, Peking University, 22 Zhong-Guan-Cun Street South, Haidian District, Beijing, China 

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:

北京大学口腔医学院 

Primary sponsor:

School of Stomatology, Peking University 

研究实施负责(组长)单位地址:

北京市海淀区中关村南大街22号 

Primary sponsor's address:

22 Zhong-Guan-Cun Street South, Haidian District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学口腔医学院

具体地址:

北京市海淀区中关村南大街22号

Institution
hospital:

School of Stomatology, Peking University

Address:

22 Zhong-Guan-Cun Street South, Haidian District

经费或物资来源:

北京大学口腔医学院 

Source(s) of funding:

School of Stomatology, Peking University 

研究疾病:

慢性牙周炎 

Target disease:

Chronic 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:

探索性研究/预试验 

Study phase:

研究目的:

采用分口、随机对照的研究方法,评价EGCG辅助龈下刮治根面平整治疗慢性牙周炎的效果并比较龈下刮治根面平整后 EGCG 溶液超声龈下冲洗及常规龈下冲洗对慢性牙周炎治疗的效果差异 

Objectives of Study:

A split-mouth, randomized controlled study was performed to evaluate the adjunctive use of (-)-epigallocatechin gallate (EGCG) aqueous solution with scaling and root planing in the management of chronic periodontitis and compare two irrigation methods of EGCG aqueous solution. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)慢性牙周炎; (2)每个后牙区段至少2颗牙PD为5-8mm; (3)上颌余留牙不少于10颗,除去智齿; 

Inclusion criteria

(1) Patients having chronic periodontitis; (2) At least two teeth having PD 5-8 mm each posterior segment; (3) More than 10 teeth in the maxillary dentition, except for wisdom teeth. 

排除标准:

(1)吸烟; (2)女性处于怀孕或哺乳期; (3)有严重的全身系统性疾病(如高血压,糖尿病,心血管疾病,肝炎、结合等传 染性疾病,抗凝药物、抗抑郁药物使用者等); (4)口腔有除牙周炎以外的其他严重感染、肿瘤或黏膜疾病需要进行治疗的; (5)在近6个月内使用过局部或全身抗生素; (6)在近6个月内进行过牙周治疗。 

Exclusion criteria:

(1) Smokers; (2) Pregnant or lactating mothers; (3) Patients having systemic diseases; (4) Patients having oral diseases like severe infections, tumors and mucosal disease; (5) Patients who have received any topical or systemic antimicrobial treatment in the past 6 months; (6) Patients who had periodontal treatment in the past 6 months. 

研究实施时间:

Study execute time:

From2018-12-01To 2019-12-01 

征募观察对象时间:

Recruiting time:

From2018-01-01To 2019-06-01 

干预措施:

Interventions:

组别:

EGCG龈上给药试验侧

样本量:

20

Group:

Supragingival medication group

Sample size:

干预措施:

EGCG水溶液+传统超声刮治尖刮治及根面平整

干预措施代码:

Intervention:

Ultrasonic scaling and root planing with EGCG aqueous solution and traditional scaling tips

Intervention code:

组别:

EGCG龈上给药对照侧

样本量:

20

Group:

Supragingival control group

Sample size:

干预措施:

蒸馏水+传统超声刮治尖刮治及根面平整

干预措施代码:

Intervention:

Ultrasonic scaling and root planing with distilled water and traditional scaling tips

Intervention code:

组别:

EGCG龈下给药试验侧

样本量:

20

Group:

Subgingival medication group

Sample size:

干预措施:

EGCG水溶液+尖端开口超声刮治尖刮治及根面平整

干预措施代码:

Intervention:

Ultrasonic scaling and root planing with EGCG aqueous solution and new-type scaling tips

Intervention code:

组别:

EGCG龈下给药对照侧

样本量:

20

Group:

Subgingival control group

Sample size:

干预措施:

蒸馏水+尖端开口超声刮治尖刮治及根面平整

干预措施代码:

Intervention:

Ultrasonic scaling and root planing with distilled water and new-type scaling tips

Intervention code:

组别:

EGCG超声冲洗组

样本量:

20

Group:

Ultrasonic irrigation group

Sample size:

干预措施:

常规刮治及根面平整后,EGCG水溶液+超声冲洗

干预措施代码:

Intervention:

After scaling and root planing, ultrasonic irrigating with EGCG aqueous solution

Intervention code:

组别:

EGCG常规冲洗组

样本量:

20

Group:

Normal irrigation group

Sample size:

干预措施:

常规刮治及根面平整后,EGCG水溶液+冲洗器

干预措施代码:

Intervention:

After scaling and root planing, normal irrigating with EGCG aqueous solution

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(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京大学口腔医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital of Stomatology, Peking University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

牙周袋探诊深度

指标类型:

主要指标 

Outcome:

Pocket probing depth, PPD

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 level, CAL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

牙龈出血指数

指标类型:

次要指标 

Outcome:

Bleeding index, BI

Type:

Secondary 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:

次要指标 

Outcome:

Gingival index, GI

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

菌斑指数

指标类型:

次要指标 

Outcome:

Plaque index, PLI

Type:

Secondary 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:

龈沟液

组织:

牙龈

Sample Name:

Gingival cervical fluid, GCF

Tissue:

Gingiva

人体标本去向

使用后保存 

说明

-80℃保存

Fate of sample:

Preservation after use 

Note:

Preservation under -80℃

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 28 years
最大 Max age 57 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):

由研究者用抛硬币的方法决定一组随机顺序记录,决定受试者哪侧为治疗侧。

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

Before the first patient was included, one of researchers obtained a sequence record by coin tossing.

盲法:

Open label

Blinding:

Open label

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):

预计试验完成后6个月内,论文发表后即公开原始数据。试验的原始数据上传至中国临床试验注册中心的ResMan原始数据共享平台(IPD共享平台),http://www.medresman.org.cn.

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

Within six months after the trail is complete or once the paper is published, the original data will be made public by the ResMan, http://www.medresman.org.cn.

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 & EDC(ResMan)

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

CRF & EDC (ResMan)

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-02-15
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