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含纳米碳酸羟基磷灰石牙膏治疗牙周炎患者根面牙本质敏感的随机对照试验
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注册号:

Registration number:

ChiCTR-IPR-17011678 

最近更新日期:

Date of Last Refreshed on:

2017-06-16 

注册时间:

Date of Registration:

2017-06-16 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

含纳米碳酸羟基磷灰石牙膏治疗牙周炎患者根面牙本质敏感的随机对照试验 

Public title:

Effectiveness of nano carbonate apatite toothpaste on root dentine hypersensitivity in periodontitis patients: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

含纳米碳酸羟基磷灰石牙膏治疗牙周炎患者根面牙本质敏感的随机对照试验 

Scientific title:

Effectiveness of nano carbonate apatite toothpaste on root dentine hypersensitivity in periodontitis patients: a randomized controlled 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:

戴安娜 

研究负责人:

丁佩惠 

Applicant:

Dai Anna 

Study leader:

Ding Peihui 

申请注册联系人电话:

Applicant telephone:

+86 18868111996 

研究负责人电话:

Study leader's telephone:

+86 18957108518 

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:

daianna@zju.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

phding@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:

浙江省杭州市江干区浙江大学华家池校区学生公寓5舍 

研究负责人通讯地址:

浙江省杭州市解放路88号 

Applicant address:

Zhejaing University, Huajiachi Campus, Hangzhou, Zhejiang, China 

Study leader's address:

88 Jiefang Road, Hangzhou, Zhejiang, 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第二医院 

Applicant's institution:

The Second Affiliated Hospital of Zhejiang University School of Medcine 

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:

2017037 

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第二医院人体研究伦理委员会 

Name of the ethic committee:

Human Research Ethics Committee of the Second Affiliated Hospital of Zhejiang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-06-06 

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:

浙江大学医学院附属第二医院 

Primary sponsor:

The Second Affiliated Hospital of Zhejiang University School of Medcine 

研究实施负责(组长)单位地址:

浙江省杭州市解放路88号 

Primary sponsor's address:

88 Jiefang Road, Hangzhou, Zhejiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江大学医学院附属第二医院

具体地址:

浙江省杭州市解放路88号

Institution
hospital:

The Second Affiliated Hospital of Zhejiang University School of Medcine

Address:

88 Jiefang Road, Hangzhou, Zhejiang

经费或物资来源:

自筹 

Source(s) of funding:

Self-raised 

研究疾病:

牙周炎 

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:

上市后药物 

Study phase:

研究目的:

评价对于中重度牙周炎患者在牙周基础治疗后存在牙本质敏感的现象,采用含有纳米羟基磷灰石的牙膏进行干预后,和对照组使用不含有纳米羟基磷灰石市售牙膏相比,其牙本质敏感程度是否有明显变化。 

Objectives of Study:

The aim of this randomized controlled clinical study is to evaluate the effectiveness of a specific toothpaste containing nano carbonate apatite on the improvement of dentine hypersensitivity immediately after scaling and root planing and its sustained relief over a 6-week period compared with control group which uses toothpaste free of nano carbonate apatite. 

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)年龄18-60岁;(2)身体健康,无全身系统性疾病;(3)中重度牙周炎患者,需一个疗程的非手术治疗(牙周刮治和根面平整术);(4)所有牙齿充填体完善、无龋齿;(5)至少有两颗牙齿在一个疗程的非手术治疗完成后有牙本质敏感症状。(VAS评分为3.0~8.0之间),且通过视诊或探诊可明确诊断患牙存在牙本质暴露情况;(6)近6个月内没有治疗过牙本质敏感症。 

Inclusion criteria

1. aged 18 to 70 years; 2. no systemic disease; 3. with a diagnosis of moderate to severe periodontitis who need to be treated with non-surgical periodontal treatment (scaling and root planing) in one session; 4. satisfactory dental restorations and no caries in all of the teeth; 5. pre-existing dentine hypersensitivity in at least two teeth(VAS between 3.0 to 8.0)and can be diagnosed by visual or probing inspection; 6. not using agents to treat hypersensitivity in the past 6 months 

排除标准:

(1)吸烟(2)严重的口腔粘膜病变慢性疾病、非常严重的牙周疾病,12个月内有牙周治疗史;(3)过敏牙齿的松动度大于Ⅰ°;(4)≥2/3牙齿缺失和/或有缺陷的充填体、冠修复,疑似牙龈炎、龋齿或隐裂牙;(5)患者戴有活动性矫治器,例如可摘局部义齿或正畸保持器;(6)患者在纳入研究之前的1个月内曾服用抗癫痫药、抗组胺药、抗抑郁药、镇静剂、镇定剂、抗炎药或者日常镇痛药,或患者在该研究期间服用以上药物;(7)怀孕或哺乳期妇女;(8)患者正参与其他任何临床研究或曾参与过脱敏牙膏研究,或最近3个月内曾使用脱敏牙膏,或在项目筛选日期前的2周内曾接受口腔预防治疗;(9)有受试产品过敏史的患者,或对口腔护理产品或其成分过敏的患者。 

Exclusion criteria:

1. smoking; 2. subjects with gross oral pathology, chronic disease, extremely advanced periodontal disease, periodontal treatment within the last 12 months; 3. hypersensitive teeth with mobility greater than one; 4. teeth with extensive (implicating equal or more than 2/3 of the crown) and/or defective restorations, suspected pulpitis, caries or cracked enamel; 5. subjects with removable appliances, such as removable partial dentures or orthodontic retainers; 6. subjects taking anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory drugs or daily analgesics within 1 month prior to enrollment to the study or if they started taking them during the course of the study; 7. pregnant or lactating women; 8. subjects who are participating in any other clinical study or who have participated in a desensitizing toothpaste study or who used a desensitizing toothpaste within the last 3 months, or had a dental prophylaxis within 2-weeks prior to the projected date of the screening visit; 9. subjects with a history of allergy to the test products, or allergies to oral care/personal care consumer products or their ingredients. 

研究实施时间:

Study execute time:

From2017-07-01To 2018-06-30 

征募观察对象时间:

Recruiting time:

From2017-07-01To 2017-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

24

Group:

control

Sample size:

干预措施:

不含纳米羟基磷灰石的市售牙膏

干预措施代码:

Intervention:

nano carbonate apatite free toothpaste

Intervention code:

组别:

试验组

样本量:

24

Group:

test group

Sample size:

干预措施:

含羟基磷灰石的牙膏

干预措施代码:

Intervention:

nano carbonate apatite toothpaste

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属第二医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Zhejiang University School of Medcine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

视觉模拟量表

指标类型:

主要指标 

Outcome:

Visual Analogue Scale

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Schiff冷刺激敏感指标

指标类型:

次要指标 

Outcome:

Schiff Cold Air Sensitivity

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:

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 60 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):

在受试者纳入前,由研究助手通过Excel 2013软件产生随机分配序列,并使试验组和对照组的比例为1:1。专门负责纳入患者的人员根据患者的招募顺序进行编号,根据这样的方法将患者分配到试验组或对照组中。

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

The random allocation sequence will be generated by secretary before subject recruitment using Excel 2013. Numbers will be assigned to patients according to recruitment date. Only one person is responsible for enrolling patients. The subjects will be randomly enrolled to groups using a single allocation ratio (1:1)

盲法:

Blinding:

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):

在试验结束后6个月内采用临床试验公共管理平台ResMan(www.medresman.org)公开原始记录的数据(包括元数据和病例记录表)和研究计划书,并向公众开放查询。

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

The individual participant data (including metadata and CRF) and research protocol will be published to the public using the China Clinical Trial Management Public Platform(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:

使用中国临床试验公共管理平台ResMan(www.medresman.org)保存和共享原始数据。

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

Metadata will be managed and shared by China Clinical Trial Management Public Platform(www.medresman.org).

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-06-16
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