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新型生物陶瓷根充糊剂临床疗效研究
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注册号:

Registration number:

ChiCTR2100053831 

最近更新日期:

Date of Last Refreshed on:

2021-11-30 

注册时间:

Date of Registration:

2021-11-30 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型生物陶瓷根充糊剂临床疗效研究 

Public title:

Outcome of root canal treatment using bioceramic and resin-based sealers in a 2-year follow-up: a randomized clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型生物陶瓷根充糊剂临床疗效研究--随机对照试验2年跟踪回访 

Scientific title:

Outcome of root canal treatment using bioceramic and resin-based sealers in a 2-year follow-up: a randomized clinical trial 

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:

胡静浩 

研究负责人:

胡静浩 

Applicant:

Jinghao Hu 

Study leader:

Jinghao Hu 

申请注册联系人电话:

Applicant telephone:

13486188522 

研究负责人电话:

Study leader's telephone:

13486188522 

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:

hujinghao@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

hujinghao@zju.edu.cn 

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:

浙江省杭州市秋涛北路166号 

研究负责人通讯地址:

浙江省杭州市秋涛北路166号 

Applicant address:

No.166 Qiutao North Road, Hangzhou, China 

Study leader's address:

No.166 Qiutao North Road, Hangzhou, 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:

浙江大学医学院附属口腔医院 

Applicant's institution:

The Affiliated Stomatology Hospital, Zhejiang University School of Medicine 

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:

2018011 

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:

浙江大学医学院附属口腔医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the Affiliated Stomatology Hospital Zhejiang University School of Medicine  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

王慧明 

Contact Name of the ethic committee:

Huiming Wang 

伦理委员会联系地址:

浙江省杭州市秋涛北路166号 

Contact Address of the ethic committee:

No.166 Qiutao North Road, Hangzhou, 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:

浙江大学医学院附属口腔医院 

Primary sponsor:

The Affiliated Stomatology Hospital, Zhejiang University School of Medicine 

研究实施负责(组长)单位地址:

浙江省杭州市秋涛北路166号 

Primary sponsor's address:

No.166 Qiutao North Road, Hangzhou, 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):

杭州

市(区县):

Country:

China

Province:

Hangzhou

City:

单位(医院):

浙江大学医学院附属口腔医院

具体地址:

浙江省杭州市秋涛北路166号

Institution
hospital:

The Affiliated Stomatology Hospital, Zhejiang University School of Medicine

Address:

No.166 Qiutao North Road, Hangzhou, China

经费或物资来源:

浙江省教育厅一般科研项目 

Source(s) of funding:

Educational Department of Zhejiang Province 

研究疾病:

牙髓病和根尖周病 

Target disease:

pulpitis and apical periodontitis 

研究疾病代码:

 

Target disease code:

 

研究类型:

治疗研究 

Study type:

Treatment study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

生物陶瓷材料(iRoot SP)和树脂类根充糊剂(AH Plus)在根管治疗中临床疗效的研究 

Objectives of Study:

To compare the effect of a bioceramic sealer (iRoot SP) or a resin-based sealer (AH Plus) on the clinical and radiographic outcomes of root canal treatment in a 2-year follow-up. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

1.初次的根管治疗; 2.有修复价值的牙齿; 3.对于参与研究知情同意。 

Inclusion criteria

1. primary endodontic treatment 2. restorable teeth 3. consent to participate in the study.  

排除标准:

1.患有系统性疾病、免疫缺陷或服用药物的患者; 2.年龄低于18周岁; 3.无发育完全的牙根,出现根尖孔开放或者牙根吸收; 4.有牙周疾病的牙齿(牙周探诊深度大于4mm) 

Exclusion criteria:

1. patients with immunosuppressive or systemic diseases or on medications, 2. age under 18-years-old, 3. immature teeth with open apices or root resorption, 4. teeth with periodontal diseases (probing depth >4 mm).  

研究实施时间:

Study execute time:

From2018-03-01To 2021-10-31 

征募观察对象时间:

Recruiting time:

From2018-03-01To 2018-12-31 

干预措施:

Interventions:

组别:

iRoot SP糊剂组

样本量:

43

Group:

iRoot SP

Sample size:

干预措施:

使用热牙胶+iRoot SP糊剂充填根管

干预措施代码:

Intervention:

root canals were obturated by warm vertical condensation of gutta-percha with iRoot SP

Intervention code:

组别:

AH Plus糊剂组