今天是:2020-08-11 星期二

美学区GBR同期即刻修复的临床应用
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注册号:

Registration number:

ChiCTR2000034638 

最近更新日期:

Date of Last Refreshed on:

2020-07-13 

注册时间:

Date of Registration:

2020-07-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

美学区GBR同期即刻修复的临床应用 

Public title:

Study of guided bone regeneration with simultaneous immediate restoration in aesthetic region 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

比较唇侧骨板缺损存在和不存在情况下即刻种植即刻修复软硬组织变化情况的回顾性队列研究 

Scientific title:

Compare the changes of soft and hard tissues in immediate implant and immediate restoration with or without labial bone plate defect: a retrospective cohort 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:

苏镇亚 

研究负责人:

莫安春 

Applicant:

Su Chenya 

Study leader:

Mo Anchun 

申请注册联系人电话:

Applicant telephone:

+86 18674522631 

研究负责人电话:

Study leader's telephone:

+86 13808062689 

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:

859404662@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

moanchun@qq.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:

成都市武侯区人民南路三段14号 

研究负责人通讯地址:

成都市武侯区人民南路三段14号 

Applicant address:

14 Third Section, Renmin Road South, Chengdu, Sichuan, China 

Study leader's address:

14 Third Section, Renmin Road South, Chengdu, Sichuan, 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:

四川大学华西口腔医院 

Applicant's institution:

West China Hospital of Stomatology, Sichuan 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:

WCHSIRB-OT-2020-146 

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:

四川大学华西口腔医院医学伦理委员会 

Name of the ethic committee:

West China Hospital of Stomatology Institutional Review Board  

伦理委员会批准日期:

Date of approved by ethic committee:

2020-05-13 

伦理委员会联系人:

张晓辉 

Contact Name of the ethic committee:

Zhang Xiaohui 

伦理委员会联系地址:

成都市武侯区人民南路三段14号 

Contact Address of the ethic committee:

14 Third Section, Renmin Road South, Chengdu, Sichuan, 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:

四川大学华西口腔医院 

Primary sponsor:

West China Hospital of Stomatology 

研究实施负责(组长)单位地址:

成都市武侯区人民南路三段14号 

Primary sponsor's address:

14 Third Section, Renmin Road South, Chengdu, Sichuan, 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

四川大学华西口腔医院

具体地址:

人民南路三段14号

Institution
hospital:

West China Hospital of Stomatology

Address:

14 Third Section of Renmin Road South

经费或物资来源:

无经费来源 

Source(s) of funding:

No source of funding 

研究疾病:

牙列缺损 

Target disease:

Dentition defect 

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:

其它 

Study phase:

N/A 

研究目的:

通过回顾性队列研究,评价唇侧骨板缺损有无,对于即刻种植即刻修复的差异性。 

Objectives of Study:

Through retrospective cohort study, to evaluate the difference between labial bone plate defect and intact in the case of immediate implant and immediate restoration. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

1) 成年人(18岁以上),性别不限; 2) 前牙区(13-23)要求种植修复,知情同意参加此临床研究; 3) 唇侧骨板高度缺损(<4mm); 4) 拔牙窝底可用骨量充足以提供初期稳定性(>35Ncm); 5)咬合关系稳定、良好的口腔卫生和身心健康。 

Inclusion criteria

1) Adults >= 18 years old; 2) Implant restoration was required in the anterior area (13-23); 3) The height defect of labial bone plate (< 4mm); 4) The available bone at the base of extraction socket was sufficient to provide initial stability (> 35Ncm); 5) Good occlusion and good oral health. 

排除标准:

1) 心脏疾病(即II级和II级以上心功能疾病);肝、肾功能异常(ALT、AST >正常值1.5倍;糖尿病患者,血糖水平控制不佳者(经控制空腹血糖仍≥8.0 mmol/L); 2) 未控制的口腔疾病患者,如进行性牙周病、严重根尖周感染、严重习惯性磨牙症患者; 3) 未得到控制的新陈代谢疾病,如糖尿病、软骨病、甲状腺疾病、严重肝肾功能障碍; 4) 骨质疏松症、骨软化症及骨硬化症等骨疾病患者; 5) 恶性肿瘤、活动性感染性病变、代谢性骨病活动期产生的各种骨缺损; 6) 全身感染或手术部位局部急性感染者; 7) 再生障碍性贫血等血液性疾病,近3个月服用抗凝药物或凝血检查不在正常范围内者; 8) 使用可能影响软硬组织愈合的药物,如长期使用镇静催眠药(连续使用3个月以上)、长期使用非甾体类消炎药或肾上腺皮质激素(连续使用3个月以上)、正在或近3个月内曾接受可能影响或促进骨代谢的药物治疗的患者; 9) 在过去6个月内以及骨愈合期间,吸烟严重的患者(吸烟超过20支/日); 10) 自身免疫性疾病; 11) 正在进行放射治疗; 12) 精神疾病、药物滥用、酗酒; 13) 已知对产品所用材料过敏者; 14) 妊娠期及哺乳期妇女。 

Exclusion criteria:

1) Heart disease (heart function disease of grade II and above); Abnormal liver and kidney function (ALT and AST > 1.5 times the upper limit of normal value; patients with diabetes, poor control of blood glucose level (fasting blood glucose is still >= 8.0mmol /L after control); 2) Patients with uncontrolled oral diseases, such as progressive periodontal disease, severe periapical infection, and severe habitual molar disease; 3) Uncontrolled metabolic diseases such as diabetes, rickets, thyroid disease, and severe liver and kidney dysfunction. 4) Patients with osteoporosis, osteomalacia and osteosclerosis; 5) Malignant tumors, active infectious lesions, and bone defects in the active phase of metabolic bone disease; 6) Systemic infection or local acute infection of the surgical site; 7) Aplastic anemia and other blood diseases, taking anticoagulant drugs or coagulation tests for 3 months is not within the normal range; 8) The use of drugs that may affect the healing of hard and soft tissues, such as long-term use of sedative hypnotics (continuous use for more than 3 months), long-term use of non-steroidal anti-inflammatory drugs or adrenal corticosteroids (continuous use for more than 3 months), and the treatment of patients who have received drugs in the current or recent 3 months that may affect or promote bone metabolism; 9) Patients with severe smoking (smoking more than 20 cigarettes/day) in the past 6 months and during bone healing; 10) Autoimmune diseases; 11) Radiation therapy is under way; 12) Mental illness, drug abuse and alcohol abuse; 13) Known allergic to the materials used in the product; 14) Women in pregnancy or lactation.  

研究实施时间:

Study execute time:

From2020-07-31To 2022-07-31 

征募观察对象时间:

Recruiting time:

From2020-07-31To 2022-07-31 

干预措施:

Interventions:

组别:

试验组

样本量:

14

Group:

Experimental group

Sample size:

干预措施:

骨板无缺损

干预措施代码:

Intervention:

Labial bone plate intact

Intervention code:

组别:

对照组

样本量:

14

Group:

Control group

Sample size:

干预措施:

骨板缺损

干预措施代码:

Intervention:

Labial bone plate defect

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川省 

市(区县):

成都市 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

四川大学华西口腔医院 

单位级别:

三甲医院 

Institution
hospital:

West China Hospital of Stomatology  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

骨厚度

指标类型:

主要指标 

Outcome:

Bone thickness

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

软组织轮廓

指标类型:

主要指标 

Outcome:

Soft tissue contour

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

红色美学评分

指标类型:

次要指标 

Outcome:

Pink esthetic score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

牙龈乳头指数评分

指标类型:

次要指标 

Outcome:

Papilla index score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

伤口愈合情况

指标类型:

次要指标 

Outcome:

Wound healing

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

种植体存活率

指标类型:

次要指标 

Outcome:

Implant survival rate

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:

CBCT

组织:

Sample Name:

CBCT

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

原始数据上传至发表学术刊物指定数据库。

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

Upload the original data to database of the scientific publication.

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:

整个试验过程严格执行临床试验质量管理规范,所有纸质CRF记录完整、真实、清晰、客观后将试验数据输入计算机,锁定数据后储存。

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

The entire trial process strictly implements the clinical trial quality management specifications. All paper CRF records are complete, true, clear, and objective. After the trial data is entered into the computer, the data is locked and stored.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-07-12
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