ChiCTR2500113552 版本V1.0 版本创建时间2025/12/01 09:39:46 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500113552 

最近更新日期：

Date of Last Refreshed on：

 2025-12-01 09:39:40 

注册时间：

Date of Registration：

 2025-12-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

光动力在根管治疗中应用的研究

Public title：

Research on the Application of Photodynamic Therapy in Root Canal Treatment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

光动力在根管治疗中应用的研究

Scientific title：

Research on the Application of Photodynamic Therapy in Root Canal Treatment

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：

殷凌云 

研究负责人：

殷凌云 

Applicant：

Yin Lingyun 

Study leader：

Yin Lingyun 

申请注册联系人电话：

Applicant telephone：

 +86 871 6321 1142

研究负责人电话：

Study leader's
telephone：

+86 871 6321 1142

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：

 243858299@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 243858299@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：

云南省昆明市盘龙区人民东路245号

研究负责人通讯地址：

云南省昆明市盘龙区人民东路245号

Applicant address：

No. 245, Renmin East Road, Panlong District, Kunming City, Yunnan Province

Study leader's address：

No. 245, Renmin East Road, Panlong District, Kunming City, Yunnan 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：

昆明市延安医院

Applicant's institution：

Yan‘an Hospital of Kunming City

研究负责人所在单位：

昆明市延安医院

Affiliation of the Leader：

Yan'An hospital of Kunming City

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：

 2025-331-01

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：

昆明市延安医院医学伦理委员会

Name of the ethic committee：

Kunming Yan 'an Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-09-18 00:00:00

伦理委员会联系人：

李琳

Contact Name of the ethic committee：

Li Lin

伦理委员会联系地址：

云南省昆明市盘龙区人民东路245号

Contact Address of the ethic committee：

No. 245, Renmin East Road, Panlong District, Kunming City, Yunnan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 871 63111318

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 aileenali@163.com

研究实施负责（组长）单位：

昆明市延安医院

Primary sponsor：

Yan'An hospital of Kunming City

研究实施负责（组长）单位地址：

云南省昆明市盘龙区人民东路245号

Primary sponsor's address：

No. 245, Renmin East Road, Panlong District, Kunming City, Yunnan 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)：

云南省

市(区县)：

Country：

China

Province：

Yunnan

City：

单位(医院)：

昆明市延安医院

具体地址：

云南省昆明市盘龙区人民东路245号

Institution
hospital：

Yan'An hospital of Kunming City

Address：

No. 245, Renmin East Road, Panlong District, Kunming City, Yunnan Province

经费或物资来源：

昆明市卫生健康委员会卫生科研课题项目

Source(s) of funding：

Health Research Project of Kunming Municipal Health Commission

研究疾病：

牙体牙髓疾病及根尖周病变  

Target disease：

Endodontic Diseases and Periapical 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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

激光作为一种新的技术应用于多种牙体牙髓疾病的治疗中已展现出较好的疗效。根管治疗术是治疗牙髓和根尖周病的最根本和最有效的方法，其中有效的化学预备和适当的荡洗方式可以增强根管内感染的控制效果，有助于清除根管壁玷污层，开放牙本质小管口，确保获得根管系统的三维充填。光动力治疗配合冲洗液可有效去除根管壁玷污层，由于根管系统的复杂性，临床上很多根管并非规则的圆形或椭圆形，狭窄的交通支和侧支根管是机械预备无法清理的，通常需要配合有效的荡洗方式对这些区域进行化学预备。很少有学者探讨光动力和传统超声荡洗对根管峡部的清理效果。课题组通过对比Er：YAG激光的SWEEPS和PIPS两种荡洗模式及超声荡洗对牙本质小管的穿透深度和范围，评价其对根管峡部的清洁效果；比较三种荡洗方式在不同牙根长度上穿透深度的变化；探索不同的根管峡部长度和宽度对清洁效果的影响；同时比较三种荡洗方式对氢氧化钙根管消毒剂的清除效果，为临床提供针对复杂根管系统可靠的清洁方式。  

Objectives of Study：

As a novel technology, laser has demonstrated favorable therapeutic outcomes in the treatment of various dental and endodontic diseases. Root canal treatment is the most fundamental and effective method for managing pulp and periapical diseases. Effective chemical preparation and appropriate irrigation modalities can enhance the control of intraradicular infection, aid in removing the smear layer from the root canal walls, open dentinal tubule orifices, and ensure three-dimensional obturation of the root canal system.Photodynamic therapy (PDT), combined with irrigants, can effectively eliminate the root canal smear layer. Due to the complexity of the root canal system, many root canals are not regularly shaped (round or oval) clinically. Narrow isthmuses and lateral canals, which are inaccessible to mechanical instrumentation, typically require effective irrigation methods for their chemical debridement.Few studies have investigated the cleaning efficacy of photodynamic therapy and conventional ultrasonic irrigation on the root canal isthmus. This research team aims to: evaluate the cleaning efficacy on the root canal isthmus by comparing the penetration depth and extent into dentinal tubules achieved by Er:YAG laser using SWEEPS and PIPS irrigation modes versus ultrasonic irrigation; compare the variations in penetration depth at different root levels among the three irrigation methods; explore the influence of different isthmus lengths and widths on the cleaning outcome

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

昆明市延安医院口腔科近 2 年内于我院因正畸治疗拔除的离体上颌前磨牙，摄 CBCT 观察确定为双根管，且根管间有明显峡部，峡部宽度在 1mm 以内，长度在 1-5mm 内的离体牙，根尖孔单一，牙冠基本完整，根尖发育完全，牙体长大于 18mm。

Inclusion criteria

The detached maxillary premolars extracted for orthodontic treatment in the Department of Stomatology of Yan 'an Hospital in Kunming City within the past two years were identified by CBCT observation as having double root canals, with a distinct isthmus between the root canals. The isthmus width is within 1mm and the length is within 1-5mm. The apical foramen is single, the tooth crown is basically intact, and the apical development is complete. The tooth length is greater than 18mm.

排除标准：

单根牙，2-2 型根管，牙根发育不全，根尖孔未闭合或直径大于 35 号 K 锉，弯曲度大于 15 度，根折，残根，残冠、畸形牙。

Exclusion criteria：

Single tooth, type 2-2 root canal, underdeveloped root, unopened apical foramen or diameter greater than 35 K file, curvature greater than 15 degrees, root fracture, residual root, residual crown, deformed tooth.

研究实施时间：

Study execute time：

从 From 2025-05-01 00:00:00至 To 2027-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-01 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：

牙本质小管渗透组

样本量：

 40

Group：

Dentin tubule infiltration group

Sample size：

干预措施：

将 40 颗离体牙分为 A、B、C、D 四组 ，每组 10 颗。 A 组：在超声工作仪 P5（赛特力, 法国）上安置尖端直径为 15#的荡洗工作尖深入根管内荡洗 30s，工作强度为 8（0-20），避免接触根管壁，根管内持续注入 3%次氯酸钠溶液，然后使用生理盐水荡洗 30S，吸干。 B 组：PIPS 组，根管内持续注入 3%次氯酸钠溶液，将 Er：YAG 激光（0.3W，15Hz，20mJ）光纤尖放人液体中荡洗 90s，然后使用生理盐水荡洗 30S，吸干。 C 组：SWEEPS 组，根管内持续注入 3%次氯酸钠溶液，在 Auto SWEEPS 模式下（Fotona,斯洛文尼亚）使用 SWEEPS600 光纤尖放人液体中荡洗 90s，然后使用生理盐水荡洗 30s，吸干。 D 组：对照组，不做荡洗，仅用 3%次氯酸钠冲洗液冲洗根管，然后使用生理盐水冲洗 30s，吸干。

干预措施代码：

Intervention：

Forty detached teeth were divided into four groups, namely A, B, C and D, with 10 teeth in each group. Group A: A 15# diameter swing washing tip was placed on the ultrasonic working instrument P5 (Seterey, France) and swept deep into the root canal for 30 seconds at a working intensity of 8 (0-20), avoiding contact with the root canal wall. 3% sodium hypochlorite solution was continuously injected into the root canal, followed by 30 seconds of swing washing with normal saline and suction drying. Group B: PIPS group, 3% sodium hypochlorite solution was continuously injected into the root canal. The tip of the Er: YAG laser (0.3W, 15Hz, 20mJ) fiber was placed in the liquid and rinsed for 90 seconds, then rinsed with normal saline for 30 seconds and dried. Group C: SWEEPS group, 3% sodium hypochlorite solution was continuously injected into the root canal. In Auto SWEEPS mode (Fotona, Slovenia), the SWEEPS600 fiber tip was placed in the liquid and rinsed for 90 seconds, then rinsed with normal saline for 30 seconds and aspirated. Group D: Control group. No rinsing was performed. Only 3% sodium hypochlorite rinsing solution was used to rinse the root canals, followed by rinsing with normal saline for 30 seconds and suction dry.

Intervention code：

组别：

氢氧化钙清除组

样本量：

 40

Group：

Calcium hydroxide removal group

Sample size：

干预措施：

将 40 颗离体牙分为 A、B、C、D 四组 ，每组 10 颗。 A 组：在超声工作仪 P5（赛特力, 法国）上安置尖端直径为 15#的荡洗工作尖深入根管内荡洗 30s，工作强度为 8（0-20），避免接触根管壁，根管内持续注入3%次氯酸钠溶液，然后使用生理盐水荡洗 30S，吸干。 B 组：PIPS 组，根管内持续注入 3%次氯酸钠溶液，将 Er：YAG 激光（0.3W，15Hz，20mJ）光纤尖放人液体中荡洗 90s，然后使用生理盐水荡洗 30S，吸干。 C 组：SWEEPS 组，根管内持续注入 3%次氯酸钠溶液，在 Auto SWEEPS 模式下（Fotona,斯洛文尼亚）使用 SWEEPS600 光纤尖放人液体中荡洗 90s，然后使用生理盐水荡洗 30s，吸干。 D 组：对照组，不做荡洗，仅用 3%次氯酸钠冲洗液冲洗根管，然后使用生理盐水冲洗 30s，吸干。

干预措施代码：

Intervention：

Forty detached teeth were divided into four groups, namely A, B, C and D, with 10 teeth in each group. Group A: A 15# diameter swing washing tip was placed on the ultrasonic working instrument P5 (Seterey, France) and swept deep into the root canal for 30 seconds at a working intensity of 8 (0-20), avoiding contact with the root canal wall. 3% sodium hypochlorite solution was continuously injected into the root canal, followed by 30 seconds of swing washing with normal saline and suction drying. Group B: PIPS group, 3% sodium hypochlorite solution was continuously injected into the root canal. The tip of the Er: YAG laser (0.3W, 15Hz, 20mJ) fiber was placed in the liquid and rinsed for 90 seconds, then rinsed with normal saline for 30 seconds and dried. Group C: SWEEPS group, 3% sodium hypochlorite solution was continuously injected into the root canal. In Auto SWEEPS mode (Fotona, Slovenia), the SWEEPS600 fiber tip was placed in the liquid and rinsed for 90 seconds, then rinsed with normal saline for 30 seconds and aspirated. Group D: Control group. No rinsing was performed. Only 3% sodium hypochlorite rinsing solution was used to rinse the root canals, followed by rinsing with normal saline for 30 seconds and suction dry.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 云南省 

市(区县)：

  

Country：

China

Province：

Yunnan

City：

单位(医院)：

 昆明市延安医院 

单位级别：

 三级甲等 

Institution
hospital：

Yan'An hospital of Kunming City

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

染料渗透深度

指标类型：

主要指标

Outcome：

The penetration depth and calcium hydroxide area were measured

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

氢氧化钙面积

指标类型：

主要指标

Outcome：

Calcium hydroxide area were measured

Type：

Primary 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：

离体牙

组织：

Sample Name：

In vitro tooth

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 岁 years
最大 Max age 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）：

由非实验操作员采用SPSS软件随机

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

Random selection was conducted by non-experimental operators using SPSS software

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：

三盲（受试者盲、研究者盲、数据分析者盲）

Blinding：

Triple blindness (subject blindness, researcher blindness, and data analyst blindness)

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-12-01 09:39:40