中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500111415
最近更新日期： Date of Last Refreshed on：	2025-10-30 22:07:17
注册时间： Date of Registration：	2025-10-30 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	使用硅酸钙水门汀联合与不联合激光治疗对儿童活髓切断术后疼痛的影响
Public title：	Postoperative Pain After Pulpotomy in Children Using Calcium Silicate Cements With and Without Laser Therapy
注册题目简写：
English Acronym：
研究课题的正式科学名称：	钙硅酸盐水门汀联合与不联合激光生物调节治疗恒磨牙活髓切断术后疼痛的评估：一项随机临床试验
Scientific title：	Evaluation of Postoperative Pain After Pulpotomy Using Calcium Silicate Cements in Permanent Molars with and without Laser Biomodulation: A Randomized Clinical 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：	Dr. Nabeel Ayappali Kalluvalappil	研究负责人：	Prof. Mohamed Medhat Kataia
Applicant：	Dr. Nabeel Ayappali Kalluvalappil	Study leader：	Prof. Mohamed Medhat Kataia
申请注册联系人电话： Applicant telephone：	+971 9 202 3517	研究负责人电话： Study leader's telephone：	+971 9 202 3518
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：	nabeelsabeel@gmail.com	研究负责人电子邮件： Study leader's E-mail：	m.kataia@fu.ac.ae
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：	阿联酋富吉拉大学牙科与健康科学学院	研究负责人通讯地址：	阿联酋富吉拉大学牙科与健康科学学院
Applicant address：	College of Dentistry and Health Sciences, Fujairah University, UAE	Study leader's address：	College of Dentistry and Health Sciences, Fujairah University, UAE
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：	阿联酋富吉拉大学
Applicant's institution：	Fujairah University, United Arab Emirates
研究负责人所在单位：	阿联酋富吉拉大学
Affiliation of the Leader：	Fujairah University, United Arab Emirates

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：	UOFREC20250422	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：	富吉拉大学研究伦理委员会
Name of the ethic committee：	Fujairah University Research Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2025-04-15 00:00:00
伦理委员会联系人：	Prof. Tamer Hassan
Contact Name of the ethic committee：	Prof. Tamer Hassan
伦理委员会联系地址：	阿联酋富吉拉大学牙科与健康科学学院
Contact Address of the ethic committee：	College of Dentistry and Health Sciences, Fujairah University, UAE
伦理委员会联系人电话： Contact phone of the ethic committee：	+971 9 202 3510	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：

阿联酋富吉拉大学

Primary sponsor：

Fujairah University, United Arab Emirates

研究实施负责（组长）单位地址：

阿联酋富吉拉大学牙科与健康科学学院

Primary sponsor's address：

College of Dentistry and Health Sciences, Fujairah University, UAE

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	阿拉伯联合酋长国	省(直辖市)：	Fujairah	市(区县)：
Country：	United Arab Emirates	Province：	Fujairah	City：
单位(医院)：	阿联酋富吉拉大学	具体地址：	阿联酋富吉拉大学牙科与健康科学学院
Institution hospital：	Fujairah University, United Arab Emirates	Address：	College of Dentistry and Health Sciences, Fujairah University

经费或物资来源：

富吉拉大学的研究人员

Source(s) of funding：

Investigators in Fujairah University

研究疾病：

有症状的不可逆性牙髓炎

Target disease：

Symptomatic Irreversible Pulpitis

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：

主要目标：比较在患有恒后牙不可逆性牙髓炎的儿童和年轻成人中，单独使用EndoCem与EndoCem联合低水平激光生物调节治疗后，牙髓切断术的术后疼痛水平。次要目标： 1 评估在3个月随访期内，辅助激光生物调节对牙髓切断术临床和放射学成功率的影响。 2 评估两组患者治疗后镇痛药物使用情况及整体舒适度。 3 确定联合疗法是否为该患者群体提供比传统根管治疗更有效、更微创的替代方案。

Objectives of Study：

Primary Objective: To compare postoperative pain levels following vital pulp therapy (pulpotomy) using EndoCem alone versus EndoCem combined with low-level laser biomodulation in children and young adults with irreversible pulpitis in permanent posterior teeth. Secondary Objectives: 1 To evaluate the effect of adjunctive laser biomodulation on clinical and radiographic success rates of pulpotomy over a 3-month follow-up period. 2 To assess the analgesic consumption and overall patient comfort following treatment in both groups. 3 To determine whether the combination approach provides a more effective and minimally invasive alternative to conventional root canal therapy in this patient population.

药物成份或治疗方案详述：

本研究针对因恒磨牙神经发炎（称为不可逆性牙髓炎）而出现严重牙痛的儿童和年轻成人。通常，该病症的标准治疗是根管治疗，即完全移除牙神经。然而，另一种称为“活髓治疗”或“牙髓切断术”的替代方案也可能适用。这种更简单的操作仅去除感染的牙髓部分，保留健康部分的神经活性，随后使用特殊材料封闭牙齿。本研究的目标是探索如何使牙髓切断术术后更加舒适。我们正在测试两种方法： 1. 仅使用新型牙科填充材料EndoCem封闭牙齿； 2. 在使用EndoCem之前，先对健康牙髓组织施加温和的激光治疗。这种称为“生物调节”的激光疗法被认为有助于镇静组织、促进愈合。参与研究的患者将被随机分配至上述两种治疗组之一。我们主要测量的指标是术后疼痛程度，患者将通过简单的疼痛评分量表进行记录。我们希望确定：在填充材料基础上联合使用激光是否能显著减轻疼痛，提升治疗后的整体体验。本研究将帮助牙医评估：将这种新型封闭材料与激光疗法结合，是否能为患有严重牙痛的患者提供一种更有效、更舒适的保牙方式。

Description for medicine or protocol of treatment in detail：

This study is for children and young adults who have a severe toothache in a permanent back molar, caused by an inflamed nerve (a condition called irreversible pulpitis). Usually, the treatment for this is a root canal, which removes the entire nerve. However, a different treatment called "vital pulp therapy" or "pulpotomy" may be an option. This simpler procedure removes only the infected part of the nerve, leaving the healthy part alive, and then seals the tooth with a special material.The goal of our research is to see if we can make this pulpotomy procedure even more comfortable for patients afterward. We are testing two approaches:Using a modern dental filling material called EndoCem to seal the tooth.Using the same EndoCem material, but first applying a gentle laser to the healthy nerve tissue. This laser treatment, known as "biomodulation," is thought to help calm the tissue and improve healing.Patients who join the study will be randomly assigned to one of these two treatment groups. The main thing we will measure is the level of pain after the procedure, which patients will record on a simple pain scale. We want to find out if using the laser in addition to the filling material leads to less pain and a better experience after the treatment.This study will help dentists understand if combining this new sealing material with laser therapy can be a more effective and comfortable way to save a tooth with a severe toothache.

纳入标准：

Inclusion criteria

排除标准：

1. 牙根尖未发育成熟的牙齿。 2. 无法修复的牙齿（严重损坏或龋坏）。 3. 手术过程中牙髓出血无法在10分钟内控制。 4. 患有可能影响牙科治疗的重大疾病的患者。 5. 牙髓已坏死的牙齿。 6. 无法或不愿意提供知情同意。 7. 属于弱势群体的个体（由伦理委员会定义）。

Exclusion criteria：

1. Teeth with immature root tips. 2. Teeth that are not restorable (severely damaged or decayed). 3. Bleeding from the tooth's nerve that cannot be controlled within 10 minutes during the procedure. 4. Patients with significant medical conditions that could complicate dental treatment. 5. Teeth with a dead (necrotic) nerve. 6. Inability or unwillingness to provide informed consent. 7. Individuals from vulnerable groups (as defined by the ethics committee).

研究实施时间：

Study execute time：

从 From 2025-04-30 00:00:00至 To 2026-03-25 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-10-30 00:00:00 至 To 2026-02-15 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	23
Group：	Control Group	Sample size：	23
干预措施：	干预类型：活髓治疗（牙髓切断术）干预名称：EndoCem 牙髓切断术剂量：一次性使用2–3 mm厚度的EndoCem预混型糊剂（基于MTA的硅酸钙水泥），直接覆盖于根部牙髓组织上。持续时间：单次治疗 session（一次性操作）。干预描述：本组受试者将接受牙髓切断术，用于治疗恒磨牙症状性不可逆性牙髓炎。在完成冠部开髓后，移除炎症的冠部牙髓并达到止血，随后按照制造商说明，将EndoCem预混型MTA糊剂（ZTM Medicare，韩国）覆盖于暴露的健康根部牙髓表面。同一次就诊中，使用永久性粘接修复体封闭患牙。本方案作为活性对照组，代表了使用现代生物陶瓷材料的标准活髓治疗方案。	干预措施代码：
Intervention：	Intervention Type: Vital pulp therapy (Pulpotomy) Intervention Name: EndoCem Pulpotomy Dose: A single application of 2–3 mm thickness of EndoCem premixed putty (MTA-based calcium silicate cement) placed directly over the radicular pulp tissue. Duration: Single treatment session (one-time procedure). Intervention Description: Participants in this group will undergo a full pulpotomy procedure for the management of symptomatic irreversible pulpitis in permanent posterior teeth. After achieving coronal access, the inflamed coronal pulp will be removed, and hemostasis will be established. The exposed healthy radicular pulp will then be covered with EndoCem premixed MTA putty (ZTM Medicare, Korea) as per manufacturer’s instructions. The tooth will subsequently be sealed with a permanent adhesive restoration in the same visit. This serves as the active control arm, representing the standard vital pulp therapy protocol using a modern bioceramic material.	Intervention code：

组别：	试验组	样本量：	23
Group：	Trial Group	Sample size：	23
干预措施：	干预类型：活髓治疗（联合激光生物调节的牙髓切断术）干预名称：EndoCem 牙髓切断术联合Er,Cr:YSGG激光生物调节剂量：在根部牙髓断面单次应用Er,Cr:YSGG激光，参数为：功率1.0 W、频率20 Hz、单脉冲能量50 mJ、水含量60%、空气含量70%，以非消融、生物刺激模式每部位照射约60秒，随后在牙髓组织表面覆盖2–3 mm厚度的EndoCem预混型MTA糊剂。持续时间：单次治疗 session（一次性操作）。干预描述：本组受试者将接受与对照组相同的标准化牙髓切断术流程。在冠部牙髓去除并达成止血后，对暴露的根部牙髓组织施加低能量Er,Cr:YSGG激光生物调节（采用上述参数），以促进牙髓愈合、减轻术后炎症。激光处理后立即使用EndoCem预混型MTA糊剂（ZTM Medicare，韩国）封闭髓室，并完成患牙的永久性修复。本组为实验组，旨在评估激光生物调节在活髓治疗后提升患者舒适度与促进愈合方面的潜在辅助作用。	干预措施代码：
Intervention：	Intervention Type: Vital pulp therapy (Pulpotomy with adjunctive laser biomodulation) Intervention Name: EndoCem Pulpotomy with Adjunctive Er,Cr:YSGG Laser Biomodulation Dose: A single application of Er,Cr:YSGG laser to the radicular pulp stumps using parameters of 1.0 W power, 20 Hz frequency, 50 mJ energy per pulse, 60% water, and 70% air, applied for approximately 60 seconds per site in a non-ablative, biostimulatory mode, followed by a 2–3 mm layer of EndoCem premixed MTA putty placed over the pulp tissue. Duration: Single treatment session (one-time application). Intervention Description: Participants in this group will receive the same standardized pulpotomy procedure as the control group. After coronal pulp removal and hemostasis, the exposed radicular pulp tissue will be subjected to low-energy Er,Cr:YSGG laser biomodulation using the above parameters to promote pulp healing and reduce postoperative inflammation. Immediately after laser application, the pulp chamber will be sealed with EndoCem premixed MTA putty (ZTM Medicare, Korea), and the tooth will be permanently restored. This arm represents the experimental group, evaluating the potential adjunctive benefit of laser biomodulation in enhancing comfort and healing following vital pulp therapy.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	阿拉伯联合酋长国	省(直辖市)：	Fujairah	市(区县)：
Country：	United Arab emirates	Province：	Fujairah	City：
单位(医院)：	阿联酋富吉拉大学牙科与健康科学学院	单位级别：	大学
Institution hospital：	College of Dentistry and Health Sciences, Fujairah University, UAE	Level of the institution：	University

测量指标：

Outcomes：

指标中文名：	术后疼痛强度采用视觉模拟量表（VAS）评估	指标类型：	主要指标
Outcome：	Postoperative Pain Intensity as assessed by Visual Analogue Scale (VAS)	Type：	Primary indicator
测量时间点：		测量方法：	术后疼痛水平由受试者自行使用100毫米视觉模拟量表（VAS）进行报告。该量表为一条水平线，左端标注“无痛”（0 mm），右端标注“可想象的最剧烈疼痛”（100 mm）。受试者在量表上标记最能代表其疼痛强度的点。得分越高，表示疼痛越剧烈。分析指标为每个指定术后时间点记录的平均VAS评分。
Measure time point of outcome：		Measure method：	Postoperative pain level will be self-reported by participants using a 100-mm Visual Analogue Scale (VAS). The scale is a horizontal line anchored by two verbal descriptors: "No pain" (0 mm) on the left and "Worst pain imaginable" (100 mm) on the right. Participants mark the line at the point that best represents their pain intensity. A higher score indicates greater pain. The outcome for analysis is the mean VAS score recorded at each specified postoperative time point.

指标中文名：	影像学成功率	指标类型：	次要指标
Outcome：	Radiographic Success Rate	Type：	Secondary indicator
测量时间点：		测量方法：	通过根尖片评估无影像学失败表现，包括无新发或扩大的根尖透射影、无外源性或内源性牙根吸收、无牙周膜间隙增宽。该结局以影像学成功例数（即达到影像学成功标准的受试者人数）进行报告。
Measure time point of outcome：		Measure method：	The absence of radiographic signs of failure, assessed via periapical radiographs. This includes the absence of new or enlarged periapical radiolucency, external or internal root resorption, or periodontal ligament space widening. The outcome is reported as the number of participants with a radiographically successful outcome.

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	9	岁 years
最大 Max age	14	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）：

采用计算机生成的随机化方法，将受试者随机分配至三组（www.randome.org）。

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

Using computer generated randomization, the participants will be allocated randomly into three groups. (www.randome.org)

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	三盲设计。试验所有成员（受试者、疼痛评估者和统计分析师）均不知晓各组所使用的具体材料。
Blinding：	Triple-blind. None of the trial members (patients, pain evaluator and statistician) will know which group received which material.
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	经合理申请，符合条件的研究人员可获得去标识化的个体受试者数据（IPD）、相关元数据、研究方案及统计分析计划。数据将通过安全的、需密码保护的机构数据传输方式共享，前提是申请人提交书面申请并签署数据使用协议。数据访问仅限于与本研究目标一致且已获伦理批准的项目。数据共享不通过任何基于网络的公共数据库进行。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	De-identified individual participant data (IPD), along with relevant metadata, the study protocol, and the statistical analysis plan, will be made available upon reasonable request from qualified researchers. Data will be shared through secure, password-protected institutional data transfer methods after approval of a written request and signing of a data access agreement. Access will be limited to ethically approved projects that align with the objectives of this study. No web-based public database will be used for data sharing.
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：	所有数据将通过为本研究专门设计的标准病例报告表（CRF）收集，CRF将记录人口学信息、临床表现、治疗细节及结局指标（疼痛评分、镇痛药物使用情况、临床与影像学评估结果）。 CRF数据将通过密码保护的电子表格或具有权限控制的专用软件录入电子数据采集（EDC）系统，并实行双人独立录入及定期交叉核对，以确保数据的准确性与完整性。所有可识别受试者身份的信息将在数据录入前移除，每位受试者将被分配唯一的研究识别编号。电子数据将安全存储于机构服务器上，定期备份，仅限授权研究人员访问。通过审计追踪与版本控制机制保障数据完整性，直至最终分析与归档完成。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	All data will be collected using a standardized Case Report Form (CRF) designed specifically for this study. The CRF will capture demographic information, clinical findings, treatment details, and outcome measures (pain scores, analgesic use, clinical and radiographic evaluations). Data from the CRFs will be entered into an electronic data capture (EDC) system using password-protected spreadsheets or dedicated software with restricted user access. Double data entry and periodic cross-checks will be performed to ensure accuracy and completeness. All identifiable patient information will be removed prior to data entry, and each participant will be assigned a unique study identification number. The electronic data will be stored securely on institutional servers with regular backup, accessible only to authorized study personnel. Data integrity will be maintained through audit trails and version control until final analysis and archiving.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2025-10-30 22:07:17