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益生菌作爲牙周病輔助治療
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注册号：

Registration number：

 ChiCTR-IOR-17010526 

最近更新日期：

Date of Last Refreshed on：

 2020-05-24 17:28:38 

注册时间：

Date of Registration：

 2017-01-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

益生菌作爲牙周病輔助治療

Public title：

Probiotics as adjunct to periodontal therapy.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

益生菌作爲牙周病輔助治療: 隨機、安慰劑平行對照試驗

Scientific title：

Effect of adjunctive probiotic therapy on periodontal pocket microbiomes: A randomized placebo controlled parallel arm study

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：

Georgios Pelekos 

研究负责人：

Georgios Pelekos 

Applicant：

Georgios Pelekos 

Study leader：

Georgios Pelekos 

申请注册联系人电话：

Applicant telephone：

 +852 2859 0343

研究负责人电话：

Study leader's
telephone：

+852 2859 0343

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

 +852-2517 0544

申请注册联系人电子邮件：

Applicant E-mail：

 george74@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 george74@hku.hk

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：

3 B 39, Prince Philip Dental Hospital, 34 Hospital Road, Sai Yin Pun, Hong Kong, China

研究负责人通讯地址：

3 B 39, Prince Philip Dental Hospital, 34 Hospital Road, Sai Yin Pun, Hong Kong, China

Applicant address：

3 B 39, Prince Philip Dental Hospital, 34 Hospital Road, Sai Yin Pun, Hong Kong, China

Study leader's address：

3 B 39, Prince Philip Dental Hospital, 34 Hospital Road, Sai Yin Pun

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：

香港大學牙醫學院

Applicant's institution：

Faculty of Dentistry, The University of Hong Kong

研究负责人所在单位：

香港大學牙醫學院

Affiliation of the Leader：

Faculty of Dentistry, The University of Hong Kong

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：

 UW-16043

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：

Institutional review Board of the University of Hong Kong Hospital Authority Hong Kong West Cluster (HKWC-HKU Cluster REC/IRB)

Name of the ethic committee：

Institutional review Board of the University of Hong Kong Hospital Authority Hong Kong West Cluster (HKWC-HKU Cluster REC/IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2016-03-22 00:00:00

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：

香港大學牙醫學院

Primary sponsor：

Faculty of Dentistry, The University of Hong Kong

研究实施负责（组长）单位地址：

Periodontology, The Prince Philip Dental Hospital, 34- Hospital Road, Hong Kong

Primary sponsor's address：

Periodontology, The Prince Philip Dental Hospital, 34- Hospital Road, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

香港大學

Source(s) of funding：

The University of Hong Kong

研究疾病：

牙周病  

Target disease：

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：

随机平行对照 

Study design：

Parallel 

研究目的：

To assess if a probiotic supplement containing Lactobacillus reuteri provided as adjunct to non-surgical periodontal therapy can improve clinical outcomes as compared to placebo. To assess subgingival and oral microbial community shifts induced by the probiotic supplement containing Lactobacillus reuteri as adjunct to non-surgical periodontal therapy.  

Objectives of Study：

To assess if a probiotic supplement containing Lactobacillus reuteri provided as adjunct to non-surgical periodontal therapy can improve clinical outcomes as compared to placebo. To assess subgingival and oral microbial community shifts induced by the probiotic supplement containing Lactobacillus reuteri as adjunct to non-surgical periodontal therapy.

药物成份或治疗方案详述：

Probiotic (lozenges containing a mixture of 200 million Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 Prodentis (Prodentis ?, Biogaia, Sweden)) or placebo lozenges as adjunct to standard non-surgical periodontal therapy (Scaling and root-surface debridement) 

Description for medicine or protocol of treatment in detail：

Probiotic (lozenges containing a mixture of 200 million Lactobacillus reuteri DSM 17938 and Lactobacillus reuteri ATCC PTA 5289 Prodentis (Prodentis ?, Biogaia, Sweden)) or placebo lozenges as adjunct to standard non-surgical periodontal therapy (Scaling and root-surface debridement) 

纳入标准：

Inclusion criteria

排除标准：

Pregnant or lactating females.
Subjects with antibiotic therapy, probiotics or anti-inflammatory drugs within past 6 months.
Radiation therapy in the head and neck area, HIV, Tuberculosis, hepatitis or other infectious diseases or uncontrolled diabetes, ischaemic heart disease, thyroid disorders or psychological problems.

Exclusion criteria：

Pregnant or lactating females.
Subjects with antibiotic therapy, probiotics or anti-inflammatory drugs within past 6 months.
Radiation therapy in the head and neck area, HIV, Tuberculosis, hepatitis or other infectious diseases or uncontrolled diabetes, ischaemic heart disease, thyroid disorders or psychological problems.

研究实施时间：

Study execute time：

从 From 2017-02-15 00:00:00至 To 2018-08-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-02-01 00:00:00 至 To 2017-10-01 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 28

Group：

2

Sample size：

干预措施：

Non surgical periodontal therapy and active probiotic

干预措施代码：

Intervention：

Non surgical periodontal therapy and placebo probiotic

Intervention code：

组别：

2

样本量：

 28

Group：

2

Sample size：

干预措施：

Non surgical periodontal therapy and placebo probiotic

干预措施代码：

Intervention：

Non surgical periodontal therapy and placebo probiotic

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

 Hong Kong 

Country：

China

Province：

SAR Hong Kong

City：

Hong Kong

单位(医院)：

 Prince Philip Dental Hospital 

单位级别：

 Prince Philip Dental Hospital 

Institution
hospital：

Faculty of Dentistry, The University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Changes in Periodontal Probing Depth

指标类型：

主要指标

Outcome：

Changes in Periodontal Probing Depth

Type：

Primary indicator

测量时间点：

3 month, 6 month

测量方法：

Clinical Examination

Measure time point of outcome：

3 month, 6 month

Measure method：

Clinical Examination

指标中文名：

Changes in Clinical Attachment Level

指标类型：

主要指标

Outcome：

Changes in Clinical Attachment Level

Type：

Primary indicator

测量时间点：

3 month, 6 month

测量方法：

Clinical Examination

Measure time point of outcome：

3 month, 6 month

Measure method：

Clinical Examination

指标中文名：

Changes in Percentage of Sites with Bleeding on Probing

指标类型：

次要指标

Outcome：

Changes in Percentage of Sites with Bleeding on Probing

Type：

Secondary indicator

测量时间点：

3 month, 6 month

测量方法：

Clinical Examination

Measure time point of outcome：

3 month, 6 month

Measure method：

Clinical Examination

指标中文名：

changes in the percentage of sites with visible plaque

指标类型：

次要指标

Outcome：

changes in the percentage of sites with visible plaque

Type：

Secondary indicator

测量时间点：

3 month, 6 month

测量方法：

Clinical Examination

Measure time point of outcome：

3 month, 6 month

Measure method：

Clinical Examination

指标中文名：

changes in microbial profile

指标类型：

附加指标

Outcome：

changes in microbial profile

Type：

Additional indicator

测量时间点：

Baseline, 1 week, 1 month, 3 month, 6 month

测量方法：

Laboratory analysis

Measure time point of outcome：

Baseline, 1 week, 1 month, 3 month, 6 month

Measure method：

Laboratory analysis

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

Preserved for 1 year

标本中文名：

组织：

Sample Name：

Dental Plaque

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

1 year

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 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）：

Aneesha Acharya (AA) will generate computerized random number sequence using R programming packages.

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

Aneesha Acharya (AA) will generate computerized random number sequence using R programming packages.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Trial participants and assessor will be blinded to treatment allocation group.

Blinding：

Trial participants and assessor will be blinded to treatment allocation group.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

Anonymised electronic dataset form will be prepared (also containing supplementary protocol, blank CRFs, dataset specifications). Data requests will be reviewed by Principal Investigator.

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

Anonymised electronic dataset form will be prepared (also containing supplementary protocol, blank CRFs, dataset specifications). Data requests will be reviewed by 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：

Raw data would be digitally formatted and stored (input into SPSS/Excel spread sheets) followed by cross checking for anomalies. PI and his team will be responsible for safekeeping the data. Any written materials will be locked up. All information will be destroyed six months after all relevant research reports have been published.

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

Raw data would be digitally formatted and stored (input into SPSS/Excel spread sheets) followed by cross checking for anomalies. PI and his team will be responsible for safekeeping the data. Any written materials will be locked up. All information will be destroyed six months after all relevant research reports have been published.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2017-01-26 12:47:24
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