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全流程Fotona双波长激光在难治性牙颈部非龋性病损治疗中的临床应用研究
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注册号：

Registration number：

 ChiCTR2400090176 

最近更新日期：

Date of Last Refreshed on：

 2024-09-25 15:18:30 

注册时间：

Date of Registration：

 2024-09-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

全流程Fotona双波长激光在难治性牙颈部非龋性病损治疗中的临床应用研究

Public title：

Research on the full-process clinical application of Fotona dual-wavelength laser in the treatment of complex non-caries cervical lesions in teeth

注册题目简写：

English Acronym：

研究课题的正式科学名称：

全流程Fotona双波长激光在难治性牙颈部非龋性病损治疗中的临床应用研究

Scientific title：

Research on the full-process clinical application of Fotona dual-wavelength laser in the treatment of complex non-caries cervical lesions in teeth

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：

黄鹂 

研究负责人：

黄鹂 

Applicant：

Huang li  

Study leader：

Huang li  

申请注册联系人电话：

Applicant telephone：

 +86 139 9196 0982

研究负责人电话：

Study leader's
telephone：

+86 139 9196 0982

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：

 474457130@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 474457130@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：

陕西省西安市新城区长乐西路145号

研究负责人通讯地址：

陕西省西安市新城区长乐西路145号

Applicant address：

No. 145, Changle West Road, Xincheng District, Xi'an City, Shaanxi Province

Study leader's address：

No. 145, Changle West Road, Xincheng District, Xi'an City, Shaanxi Province

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：

中国人民解放军空军军医大学(原第四军医大学)第三附属医院

Applicant's institution：

Third Affiliated Hospital of the People's Liberation Army of China Air Force Military Medical University (formerly the Fourth Military Medical University).

研究负责人所在单位：

中国人民解放军空军军医大学(原第四军医大学)第三附属医院

Affiliation of the Leader：

Third Affiliated Hospital of the People's Liberation Army of China Air Force Military Medical University (formerly the Fourth Military Medical 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：

 KQ-YJ-2024-213

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：

空军军医大学（原第四军医大学）第三附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Third Affiliated Hospital of the Air Force Military Medical University (formerly the Fourth Military Medical University)

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-09-19 00:00:00

伦理委员会联系人：

宋雅

Contact Name of the ethic committee：

Song ya

伦理委员会联系地址：

陕西省西安市新城区长乐西路145号

Contact Address of the ethic committee：

No. 145, Changle West Road, Xincheng District, Xi'an City, Shaanxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 29 8477 2512

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：

中国人民解放军空军军医大学(原第四军医大学)第三附属医院

Primary sponsor：

Third Affiliated Hospital of the People's Liberation Army of China Air Force Military Medical University (formerly the Fourth Military Medical University).

研究实施负责（组长）单位地址：

陕西省西安市新城区长乐西路145号

Primary sponsor's address：

No. 145, Changle West Road, Xincheng District, Xi'an City, Shaanxi Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

陕西

市(区县)：

Country：

China

Province：

Shaanxi

City：

单位(医院)：

中国人民解放军空军军医大学(原第四军医大学)第三附属医院

具体地址：

陕西省西安市新城区长乐西路145号

Institution
hospital：

Third Affiliated Hospital of the People's Liberation Army of China Air Force Military Medical University (formerly the Fourth Military Medical University)

Address：

No. 145, Changle West Road, Xincheng District, Xi'an City, Shaanxi Province

经费或物资来源：

国家口腔疾病临床医学研究中心专项课题

Source(s) of funding：

Special project of China National Clinical Research Center for Oral Diseases

研究疾病：

难治性牙颈部非龋性病损  

Target disease：

complex non-caries cervical lesions in teeth

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在通过前瞻性临床实验，评估全流程激光治疗技术用于解决临床常见病非龋性颈部缺损（noncarious cervical lesions，NCCL）粘接修复的临床疗效，评估该技术用于提高NCCL粘接成功率、降低患者敏感症状的可行性，为全流程激光治疗技术在NCCL粘接修复中的应用提供全面、科学的理论和实践依据。  

Objectives of Study：

The purpose of this study was to evaluate the clinical efficacy of full-process laser therapy technology in solving the clinical treatment of noncarious cervical lesions (NCCL) bonding and repair, which is a common clinical disease, and to evaluate the feasibility of this technology to improve the success rate of NCCL bonding and reduce patients' sensitive symptoms, so as to provide a comprehensive and scientific theoretical and practical basis for the application of full-process laser therapy technology in NCCL bonding and repair

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1）患牙有牙髓炎症状； 2）患牙6月内接受过专业脱敏治疗； 3）患牙有颈部缺损，却无任何敏感不适症状； 4）患者主观不愿接受激光治疗； 5）患者3月内接受过牙周治疗； 6）患者有严重的全身性疾病，无法耐受操作； 7）患者处于妊娠期、哺乳期； 8）患者同期正在参与其他临床试验，对现有临床试验结果有影响者。

Exclusion criteria：

1) The tooth has symptoms of pulpitis; 2) The affected tooth has received professional desensitization treatment within 6 months; 3) The affected tooth has a neck defect, but there is no sensitive and uncomfortable symptoms; 4) the patient's subjective unwillingness to undergo laser treatment; 5) The patient has received periodontal treatment within 3 months; 6) The patient has a severe systemic disease and is unable to tolerate the operation; 7) The patient is pregnant or lactating; 8) Patients who are participating in other clinical trials during the same period and have an impact on the results of existing clinical trials.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2027-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-10-01 00:00:00 至 To 2026-04-01 00:00:00

干预措施：

Interventions：

组别：

激光牙本质预备组

样本量：

 35

Group：

Laser dentin preparation group

Sample size：

干预措施：

患牙区域使用橡皮障隔离唾液，使用Fotona双波长激光治疗仪中Er：YAG激光（R14光纤，20mJ，20Hz，0.4w，MSP，光斑直径3mm，8%水，4%气，照射距离5mm，照射时间6s）进行牙本质预备，37%磷酸酸蚀牙本质15s，冲洗30s，窝洞内涂布自酸蚀粘接剂（3M Single Bond Universal，美国），气枪轻吹5s，光固化灯照射15s，纳米树脂（3M?Filtek Z350 XT，美国）分层充填堆积，第一层不超过1mm，余下每层不超过2mm，每层树脂光固化灯照射30s。涡轮机去除多余树脂材料，树脂表面高度抛光。

干预措施代码：

Intervention：

The affected tooth area was isolated by rubber dam, Er:YAG laser (R14 fiber, 20mJ, 20Hz, 0.4w, MSP, spot diameter 3mm, 8% water, 4% gas, irradiation distance 5mm, irradiation time 6s) in the Fotona dual-wavelength laser treatment instrument was used for dentin preparation, 37% phosphoric acid etching dentin for 15s, irrigation for 30s, and self-etching adhesive in the cavity (3M Single Bond Universal, United States), The air gun blows lightly for 5s, the light curing lamp irradiates for 15s, and the nano resin (3M Filtek Z350 XT, United States) is filled and stacked in layers, the first layer does not exceed 1mm, the remaining layers do not exceed 2mm, and each layer of resin curing lamp illuminates for 30s. The turbine removes excess resin material, and the resin surface is highly polished.

Intervention code：

组别：

激光酸蚀组

样本量：

 35

Group：

Laser etching group

Sample size：

干预措施：

患牙区域使用橡皮障隔离唾液，使用涡轮机制备牙本质统一洞形，使用Fotona双波长激光治疗仪中Er：YAG激光（R02光纤，120mJ，10Hz，1.2w，MSP，光斑直径3mm，8%水，4%气，照射距离5mm，照射时间6s）对牙本质表面进行非接触式扫描照射酸蚀，光源与被照射牙面垂直，激光以“叠瓦式”从窝洞的一端移动到另一端。窝洞内涂布自酸蚀粘接剂（3M Single Bond Universal，美国），气枪轻吹5s，光固化灯照射15s，纳米树脂（3M?Filtek Z350 XT，美国）分层充填堆积，第一层不超过1m，余下每层不超过2mm，每层树脂光固化灯照射30s。涡轮机去除多余树脂材料，树脂表面高度抛光。

干预措施代码：

Intervention：

The affected tooth area was isolated by a rubber dam, the dentin was prepared by a turbine mechanism to unify the cavity, and the Er:YAG laser (R02 optical fiber, 120mJ, 10Hz, 1.2w, MSP, spot diameter 3mm, 8% water, 4% gas, irradiation distance 5mm, irradiation time 6s) in the Fotona dual-wavelength laser treatment instrument was used to irradiate the dentin surface for non-contact scanning and acid etching, the light source was perpendicular to the irradiated tooth surface, and the laser moved from one end of the cavity to the other end in a "shingled type". The cavity is coated with self-etching adhesive (3M Single Bond Universal, United States), air gun blows lightly for 5s, light curing lamp irradiation for 15s, nano resin (3M Filtek Z350 XT, United States) layer filling and stacking, the first layer does not exceed 1m, the remaining layer does not exceed 2mm, and each layer of resin curing lamp irradiates 30s. The turbine removes excess resin material, and the resin surface is highly polished.

Intervention code：

组别：

激光脱敏组

样本量：

 35

Group：

Laser desensitization group

Sample size：

干预措施：

患牙区域使用橡皮障隔离唾液，使用涡轮机制备牙本质统一洞形，37%磷酸酸蚀牙本质15s，冲洗30s，使用Fotona双波长激光治疗仪中Nd:YAG激光（3000um光纤，10Hz，1.0w，SP）对牙本质表面进行非接触式扫描照射脱敏，照射距离5mm，照射时间6s，光源与被照射牙面垂直，激光以“叠瓦式”从窝洞的一端移动到另一端。窝洞内涂布自酸蚀粘接剂（3M Single Bond Universal，美国），气枪轻吹5s，光固化灯照射15s，纳米树脂（3M?Filtek Z350 XT，美国）分层充填堆积，第一层不超过1mm，余下每层不超过2mm，每层树脂光固化灯照射30s。涡轮机去除多余树脂材料，树脂表面高度抛光。

干预措施代码：

Intervention：

The affected tooth area was isolated by a rubber dam, the dentin was prepared by a turbine mechanism to unify the hole shape, 37% phosphoric acid etched dentin for 15s, rinsed for 30s, and the Nd:YAG laser (3000um optical fiber, 10Hz, 1.0w, SP) in the Fotona dual-wavelength laser treatment instrument was used to carry out non-contact scanning and desensitization of the dentin surface, the irradiation distance was 5mm, the irradiation time was 6s, the light source was perpendicular to the irradiated tooth surface, and the laser moved from one end of the cavity to the other end in a "shingled style". The cavity is coated with self-etching adhesive (3M Single Bond Universal, United States), air gun blows lightly for 5s, light curing lamp irradiates 15s, nano resin (3M Filtek Z350 XT, United States) is filled and stacked in layers, the first layer does not exceed 1mm, the remaining layer does not exceed 2mm, and each layer of resin curing lamp irradiates 30s. The turbine removes excess resin material, and the resin surface is highly polished.

Intervention code：

组别：

全流程激光组

样本量：

 35

Group：

Full-process laser group

Sample size：

干预措施：

患牙区域使用橡皮障隔离唾液，使用Fotona双波长激光治疗仪中Er：YAG激光（R14光纤，20mJ，20Hz，0.4w，MSP，光斑直径3mm，8%水，4%气，照射距离5mm，照射时间6s）进行牙本质预备，接着使用Er：YAG激光（R02光纤，120mJ，10Hz，1.2w，MSP，光斑直径3mm，8%水，4%气，照射距离5mm，照射时间6s）对牙本质表面进行非接触式扫描照射酸蚀，再用Nd:YAG激光（3000um光纤，10Hz，1.0w，SP，照射距离5mm，照射时间6s）对牙本质表面进行非接触式扫描照射脱敏，所有激光操作时，光源要与被照射牙面垂直，激光以“叠瓦式”从窝洞的一端移动到另一端。之后在窝洞内涂布自酸蚀粘接剂（3M Single Bond Universal，美国），气枪轻吹5s，光固化灯照射15s，纳米树脂（3M?Filtek Z350 XT，美国）分层充填堆积，第一层不超过1mm，余下每层不超过2mm，每层树脂光固化灯照射30s。涡轮机去除多余树脂材料，树脂表面高度抛光。

干预措施代码：

Intervention：

The affected tooth area was isolated from saliva by rubber dam, and Er:YAG laser (R14 fiber, 20mJ, 20Hz, 0.4w, MSP, spot diameter 3mm, 8% water, 4% gas, irradiation distance 5mm, irradiation time 6s) was used in the Fotona dual-wavelength laser treatment instrument for dentin preparation, followed by Er:YAG laser (R02 fiber, 120mJ, 10Hz, 1.2w, MSP, spot diameter 3mm, 8% water, 4% gas, irradiation distance 5mm). , irradiation time 6s) to carry out non-contact scanning irradiation acid etching on the dentin surface, and then use Nd:YAG laser (3000um optical fiber, 10Hz, 1.0w, SP, irradiation distance 5mm, irradiation time 6s) to carry out non-contact scanning irradiation desensitization on the dentin surface, all laser operations, the light source should be perpendicular to the irradiated tooth surface, and the laser moves from one end of the pit to the other end in a "shingling type". After that, the self-etching adhesive (3M Single Bond Universal, United States) was coated in the cavity, the air gun was lightly blown for 5s, the curing lamp irradiated for 15s, and the nano resin (3M Filtek Z350 XT, United States) was filled and stacked in layers, the first layer did not exceed 1mm, the remaining layers did not exceed 2mm, and each layer of resin curing lamp irradiated for 30s. The turbine removes excess resin material, and the resin surface is highly polished.

Intervention code：

组别：

对照组

样本量：

 35

Group：

Control group

Sample size：

干预措施：

患牙区域使用橡皮障隔离唾液，使用涡轮机制备牙本质统一洞形，37%磷酸酸蚀牙本质15s，冲洗30s，窝洞内涂布自酸蚀粘接剂（3M Single Bond Universal，美国），气枪轻吹5s，光固化灯照射15s，纳米树脂（3M Filtek Z350 XT，美国）分层充填堆积，第一层不超过1mm，余下每层不超过2mm，每层树脂光固化灯照射30s。涡轮机去除多余树脂材料，树脂表面高度抛光。

干预措施代码：

Intervention：

The affected tooth area is isolated by rubber dam, the dentin is prepared by a turbine mechanism to unify the hole shape, 37% phosphoric acid etching dentin for 15s, rinsing for 30s, the cavity is coated with self-etching adhesive (3M Single Bond Universal, United States), air gun blowing for 5s, curing lamp irradiation for 15s, nano resin (3M Filtek Z350 XT, United States) layered filling and stacking, the first layer does not exceed 1mm, and the remaining layers do not exceed 2mm, Each layer of resin curing lamp irradiates for 30s. The turbine removes excess resin material, and the resin surface is highly polished.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 陕西 

市(区县)：

  

Country：

China

Province：

Shaanxi

City：

单位(医院)：

 中国人民解放军空军军医大学(原第四军医大学)第三附属医院 

单位级别：

 三甲 

Institution
hospital：

Third Affiliated Hospital of the People's Liberation Army of China Air Force Military Medical University (formerly the Fourth Military Medical University).

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

冷诊刺激+VAS疼痛评分法评价

指标类型：

主要指标

Outcome：

Cold diagnosis stimulus + VAS pain score evaluation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

气流刺激+VAS疼痛评分法评价

指标类型：

次要指标

Outcome：

Airflow stimulation + VAS pain score evaluation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Yeaple电压力测试探针+VAS疼痛评分法评价

指标类型：

次要指标

Outcome：

Yeaple Electrostress Test Probe + VAS Pain Score Evaluation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

牙髓电活力测试

指标类型：

次要指标

Outcome：

Pulp electrical viability test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

影像学检查

指标类型：

次要指标

Outcome：

Imaging tests

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

充填物密合性检查

指标类型：

次要指标

Outcome：

Fill tightness check

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

充填物边缘染色检查

指标类型：

次要指标

Outcome：

Staining of the edges of the filling

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

充填物固位情况检查

指标类型：

次要指标

Outcome：

Check the retention of the filling

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：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 岁 years
最大 Max age 60 岁 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）：

采用区组随机化法，由SAS9.4软件生成区组随机数字表，通过基于网络的随机化系统进行随机分组（http://www.epiedc.com/kf. php）

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

The block randomization method was used to generate the block random number table by SAS9.4 software, and the randomization was carried out by the network-based randomization system (http://www.epiedc.com/kf. php)

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本研究采用盲法评价，所有治疗操作由高年资医师按规范统一实施，治疗前后的随访观察评价由独立的研究医生实施，治疗与评价分别在两个独立的房间进行，患者不可告知研究医师接受的具体治疗，独立的研究医生在盲态下对患者进行观察评价。

Blinding：

In this study, blinded evaluation was adopted, all treatment operations were uniformly implemented by senior physicians according to the norms, and the follow-up observation and evaluation before and after treatment were carried out by independent research doctors, and the treatment and evaluation were carried out in two separate rooms.

是否共享原始数据：

IPD sharing

否No

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）：

无

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

none

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：

病例记录表(Case Record Form, CRF）

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

Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-09-25 15:18:23
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