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罹患重度牙周炎上颌磨牙拔除前、后行侧壁开窗上颌窦底提升术效果的临床观察
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注册号:

Registration number:

ChiCTR1900020648 

最近更新日期:

Date of Last Refreshed on:

2019-01-11 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

罹患重度牙周炎上颌磨牙拔除前、后行侧壁开窗上颌窦底提升术效果的临床观察 

Public title:

Histological, radiological and clinical outcomes of sinus floor elevation using lateral aproach before/after the extraction of the severe periodontally compromised maxillary molars: a split-mouth randomized clinical trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

罹患重度牙周炎上颌磨牙拔除前、后行侧壁开窗上颌窦底提升术效果的临床观察 

Scientific title:

Histological, radiological and clinical outcomes of sinus floor elevation using lateral aproach before/after the extraction of the severe periodontally compromised maxillary molars: a split-mouth 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:

岳兆国 

研究负责人:

侯建霞 

Applicant:

Zhaoguo Yue 

Study leader:

Jianxia Hou 

申请注册联系人电话:

Applicant telephone:

+86 13381237263 

研究负责人电话:

Study leader's telephone:

+86 010-82195367 

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:

2595100029@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

jxhou@163.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 Zhongguancun Street South, Haidian District, Beijing, China 

Study leader's address:

22 Zhongguancun 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:

北京大学口腔医院 

Applicant's institution:

Peking University School Of Stomatology 

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-201840191 

伦理委员会批件附件:

Approved file of Ethical Committee:

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办公室 

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:

 

伦理委员会联系人:

贾效伟 

Contact Name of the ethic committee:

Xiaowei Jia 

伦理委员会联系地址:

北京市海淀区中关村南大街22号 

Contact Address of the ethic committee:

Peking University School Of Stomatology, 22 Zhongguancun 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:

北京大学口腔医院 

Primary sponsor:

Peking University School Of Stomatology 

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 Zhongguancun 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):

北京大学口腔医院

具体地址:

北京市海淀区中关村南大街22号

Institution
hospital:

Peking University School Of Stomatology

Address:

22 Zhongguancun Street South, Haidian District, Beijing, China

经费或物资来源:

研究生课题 

Source(s) of funding:

postgraduate research 

研究疾病:

口腔种植 

Target disease:

dental impants 

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:

III期临床试验 

Study phase:

研究目的:

本研究的目的是通过分口对照以及前瞻性临床研究分析比较拔牙后侧壁开窗上颌窦底提升术与不拔牙侧壁开窗上颌窦底提升术术中术后患者的主观感受,以及成骨期间患者对口腔功能的满意度;同时通过影像学及组织学方法分析比较两种方式的植骨效果。 

Objectives of Study:

The aim of this study is to compare the outcomes of Sinus elevation using Lateral approach without tooth extraction with the ones of the standard approachincluding the comparison of the patients satisfaction and the comparison of the outcomes of bone grafting both Histologically and radiologically. 

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:

双侧上颌第一和/或第二磨牙因重度牙周炎需要拔除后种植修复的患者 剩余牙槽骨高度(CBCT显示牙槽嵴顶至上颌窦底的距离)在1-4mm之间 年龄大于18周岁 口腔卫生及依从性良好 上颌窦健康者,CBCT显示上颌窦显影清亮者 不吸烟的患者 无明显系统性疾病患者:无严重心、肺、脑等系统性疾病、肝肾功能正常、凝血功能正常者 获得知情同意的患者 

Inclusion criteria

1. Patents with bilateral first/second molars which need to be extracted due to severe periodontal disease and need to be replaced by implants; 2. Residual alveolar bone height of these teeth is between 1-4mm; 3. Patients aged 18 years old; 4. Patients with optimal oral hygiene and good compliance; 5. Patients with healthy maxillary sinuses; 6. The general of patient are suitable for implant placement and sinus floor elevation; 7. The patient who is willing to sign the informed consent and to follow the experimental follow-up rules. 

排除标准:

剩余牙槽骨高度(CBCT牙槽嵴顶至上颌窦底的距离)小于1mm或大于4mm 患者年龄小于等于18周岁 口腔卫生差/余牙有未控制的牙周炎患者 上颌窦急慢性炎症、上颌窦囊肿等上颌窦疾病 吸烟患者 伴有全身性疾病的患者:未控制的糖尿病、心血管疾病、免疫系统疾病、凝血障碍性疾病等血液病、严重骨质疏松患者 不同意参与试验,未签署知情同意书 

Exclusion criteria:

1. Residual alveolar bone height of these teeth is more than 4mm or less than 1mm; 2. Patients with poor oral hygiene and/or active periodontitis; 3. Patients who is suffering rhinitis, sinusitis; or rather large cyst is found in the maxillary sinus; 4. Smokers; 5. Patients who is suffering Uncontrolled systemic diseases as diabetes, cardiovascular diseases, immune system diseases, severe osteoporosis and so on; 6. Patients who is NOT willing to sign the informed consent and refuse to follow the experimental follow-up rules. 

研究实施时间:

Study execute time:

From2019-02-01To 2021-02-01 

干预措施:

Interventions:

组别:

实验组

样本量:

10

Group:

Group 1

Sample size:

干预措施:

拔牙前侧壁开窗上颌窦底提升

干预措施代码:

Intervention:

Sinus floor elevation before the extraction

Intervention code:

组别:

对照组

样本量:

10

Group:

Group 2

Sample size:

干预措施:

拔牙后侧壁开窗上颌窦底提升

干预措施代码:

Intervention:

Sinus floor elevation after the extraction

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:

Peking University School Of Stomatology  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

术后不适(疼痛)

指标类型:

主要指标 

Outcome:

Post operative discomfort (pain)

Type:

Primary indicator 

测量时间点:

测量方法:

视觉模拟评分法评估

Measure time point of outcome:

Measure method:

Visual analog scales

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

牙槽骨

组织:

Sample Name:

Alveolar bone

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction 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 years
最大 Max age 100 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):

本研究将纳入的双侧上颌第一和/或第二磨牙因重度牙周炎需要拔除后种植修复的患者分口对照,研究者利用随机数生成器(Randomizer for Clinical Trials, Institute for Medical Informatics, Statistics and Documentation, Medical Univ. Graz)将需种植修复的两侧随机分为实验组和对照组。

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

In current study, investigators will devide two sides of the patients' maxilla, which need to be placed with implants after the extraction of the teeth, into two groups, using a split-mouth design. Preoperative randomizing will be performed to determine test and control site in each case.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

临床试验公共管理平台 http://www.medresman.org

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

Resman research manager http://www.medresman.org

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:

试验设计者设计基本信息登记表、病例报告表、影像学记录表,并在不同随访时间记录,研究者根据受试者检查情况,将数据完整、正确、清晰地记录在病例报告表和影像学记录表中。并将此作为依据,将受试者信息录入到电子数据采集和管理系统(Resman research manager)。所有研究对象的病例资料和专项检查表均按编号的顺序归档保存,以备查考。电子数据文件分类保存,并有多个备份保存于磁盘以及网络上,妥善保存,防止损坏。所有原始档案应按相应规定内的期限保存。

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

The investigators designs the registration form of the Basic Information, Case Report Form and Imaging Record Form, and recorded the data at different follow-up time. The researcher should record the data completely, correctly and clearly.Based on this, the subject information was entered into the Electronic Fata Capture(Resman research manager).All study subjects' case data and special examination forms were archived in order of number for reference.Electronic data files are classified and saved, and there are multiple backups saved on disk and network, properly saved to prevent damage.All original files shall be kept within the period specified accordingly.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-11
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