nrc全国计算机考试时间,ChiCTR-TNRC-11001236 版本V1.0 版本创建时间2015/7/6 19:52:44 中国临床试验注册中心...

研究实施负责(组长)单位：

中山大学光华口腔医学院·附属口腔医院

Primary sponsor：

Guanghua College of Stomatology, Hospital of Stomatology, Sun Yat-sen University

研究实施负责(组长)单位地址：

广东省广州市陵园西路56号中山大学光华口腔医学院?附属口腔医院

Primary sponsor's address：

Guanghua College of Stomatology, Hospital of Stomatology, Sun Yat-sen University, Lingyuan Xi Road 56#, Guangzhou, 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)：

Beyond Technology Corp

具体地址：

北京市金桐西路10号 远洋光华国际 AB座6层

Institution

hospital：

Beyond Technology Corp

Address：

The Office Park, Tower AB, 6th Floor, 10 Jintongxi Road, Chaoyang District, Beijing

经费或物资来源：

Beyond Technology Corp.

Source(s) of funding：

Beyond Technology Corp.

研究疾病：

牙齿变色

Target disease：

Colored tooth

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：

4

研究目的：

比较联合漂白技术与深层漂白技术的漂白效果、牙齿复色及牙齿敏感，为临床医生更好地选择牙齿漂白治疗方案提供依据

Objectives of Study：

To evaluate the degree of color change of teeth, the tooth sensitivity and the rebound effect (6-month follow-up) associated with the use of combined bleaching technique and deep bleaching technique.

研究设计：

非随机对照试验

Study design：

Non randomized control

纳入标准：

1. 6个上前牙均为活髓牙;

2. 6个上前牙唇面完整，无充填体;

3. 愿意签署知情同意书;

4. 年龄18岁至30岁之间;

5. 能配合定期复查;

6. 实验期间不吸食烟草及其制品;

7. 所有前牙颜色电脑比色仪测得深度为A2或深于A2

Inclusion criteria

1. Have all six maxillary anterior teeth with vital pulp;

2. Have no maxillary anterior teeth with more than 1/6 of their labial surface covered with a restoration;

3. Be willing to sign a consent form;

4. Be at least 18 years of age;

5. Be able to return for periodic follow-ups;

6. Be willing to refrain from the use of tobacco products during the study period;

7. Have 6 maxillary anterior teeth that are A2 or darker shade on the Vita Classic Shade Guide, and remeasured by a spectrophotometer.

排除标准：

1. 有影响试验的系统性疾病或者需要特殊照顾者;

2. 对过氧化氢过敏者;

3. 正在使用或曾使用过专业的家庭或诊室漂白产品者;

4. 口腔内有病变者(龋齿除外);

5. Loe and Silness牙龈指数超过1;

6. 妊娠及哺乳期妇女;

7. 四环素牙和氟斑牙患者;

8. 正在使用上下前牙矫治器者

Exclusion criteria：

1. Have a history of any medical disease that may interfere with the study or require special considerations;

2. Have a history of allergy to hydrogen peroxide;

3. Have current or previous use of professionally applied or prescribed “in-office” or “at-home” whitening agents;

4. Have a gross pathology in the oral cavity (excluding caries);

5. Loe and Silness Gingival score greater than 1;

6. Pregnant or lactating women;

7. Tetracycline-stained teeth and dental fluorosis;

8. Presence or use of an orthodontic appliance on six maxillary anterior teeth.

研究实施时间：

Study execute time：

从From2010-07-01至To 2011-06-30