Effect of Local Anesthesia Techniques on Pulp Hemostasis in Primary Molars
2026年9月10日 更新者：Ayça Hande Sari、Afyonkarahisar Health Sciences University
Effect of Mandibular Anesthesia and Computer-Controlled Local Anesthesia on Pulp Hemostasis Time During Pulpotomy Treatment of Mandibular Primary Molars: A Split-Mouth Study
The goal of this clinical trial is to compare the effects of two local anesthesia techniques on pulp hemostasis time during pulpotomy treatment of mandibular primary molars in children aged 6-9 years.
The main questions it aims to answer are:
Does the local anesthesia technique affect the time required to achieve pulp hemostasis during pulpotomy? Are there differences between the two anesthesia techniques in terms of pain, heart rate, and oxygen saturation during treatment?
Researchers will compare conventional inferior alveolar nerve block anesthesia with computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system to determine whether the anesthesia technique affects pulp hemostasis time and the secondary clinical outcomes.
Each participant will receive both anesthesia techniques in a randomized order using a split-mouth design. Participants will:
Receive conventional inferior alveolar nerve block anesthesia for pulpotomy treatment of one mandibular primary molar.
Receive computer-controlled intraosseous local anesthesia using the QuickSleeper 5 system for pulpotomy treatment of the contralateral mandibular primary molar at a separate treatment session.
Have pulp hemostasis time recorded during each pulpotomy procedure. Have pain, heart rate, and oxygen saturation assessed during the treatment procedures.
研究概览
地位
招聘中
条件
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ayça Hande Sari
- 电话号码：+905065143594
- 邮箱：aycahande94@gmail.com
学习地点
-
-
Afyonkarahisar
-
Afyonkarahisar、Afyonkarahisar、土耳其（türkiye）、03030
- 招聘中
- Afyonkarahisar Health Sciences University, Faculty of Dentistry
-
接触：
- Ayça Hande Sari
- 电话号码：+905065143594
- 邮箱：aycahande94@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
是的
描述
Inclusion Criteria:
- Children aged 6-9 years.
- Presence of a pulpotomy indication in both mandibular primary second molars (teeth 75 and 85).
- Systemically healthy children classified as ASA physical status I or II.
- No known coagulation disorders.
- No use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Sufficient cooperation and compliance to allow completion of the planned clinical procedures.
- Written informed consent obtained from a parent or legal guardian for participation in the study.
- No history of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
Exclusion Criteria:
- Children with systemic health conditions classified as ASA physical status III or higher.
- Known allergy or hypersensitivity to the local anesthetic agents or other dental materials used in the study.
- Presence of a known coagulation disorder or use of analgesic, anti-inflammatory, antithrombotic, or antipyretic medications within the previous 7 days.
- Presence of severe infection, pulp necrosis, advanced root resorption, or any other dental condition requiring a treatment approach other than pulpotomy in the mandibular primary second molars.
- Insufficient cooperation or behavioral difficulties that would prevent completion of the planned clinical procedures.
- History of a serious adverse reaction or complication associated with either of the local anesthesia techniques used in the study.
- Inability to comply with the study protocol or attend the scheduled study visits.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：IANB Followed by Intraosseous Anesthesia
Participants allocated to this sequence will receive conventional inferior alveolar nerve block (IANB) anesthesia for pulpotomy treatment of one mandibular primary molar at the first treatment session.
At the second treatment session, computer-controlled intraosseous anesthesia will be administered for pulpotomy treatment of the contralateral mandibular primary molar.
The time required to achieve pulp hemostasis will be recorded during both treatment sessions.
|
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte).
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
|
|
实验性的：Intraosseous Anesthesia Followed by IANB
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol, and the time required to achieve pulp hemostasis will be recorded.
|
Conventional inferior alveolar nerve block anesthesia will be administered before pulpotomy treatment of the mandibular primary molar using a standard dental syringe and an articaine-based local anesthetic solution (Ultracain D-S Forte).
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue.
Computer-controlled intraosseous local anesthesia will be administered using the QuickSleeper 5 system (Dental Hi-Tec, France) and an articaine-based local anesthetic solution (Ultracain D-S Forte) before pulpotomy treatment of the mandibular primary molar.
After adequate anesthesia is achieved, pulpotomy will be performed according to the study protocol.
Pulp hemostasis time will be recorded following removal of the coronal pulp tissue
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pulp Hemostasis Time
大体时间：During pulpotomy, up to 5 minutes after coronal pulp removal
|
The time required to achieve pulp hemostasis following removal of the coronal pulp tissue during pulpotomy will be recorded for each treatment session.
Hemostasis will be assessed using standardized sterile cotton pellets and categorized according to the time required to achieve bleeding control: ≤2 minutes, >2 to 5 minutes, or failure to achieve hemostasis within 5 minutes.
|
During pulpotomy, up to 5 minutes after coronal pulp removal
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peripheral Oxygen Saturation (SpO₂)
大体时间：Immediately before local anesthesia administration
|
Peripheral oxygen saturation (SpO₂) will be measured using a pulse oximeter and recorded as a percentage (%) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
|
Immediately before local anesthesia administration
|
|
Pain Intensity
大体时间：Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
|
Pain intensity will be assessed using the Wong-Baker FACES Pain Rating Scale.
Participants will select the face that best represents their perceived pain.
The scale ranges from 0 (no pain) to 10 (worst pain), with higher scores indicating greater pain intensity.
Pain will be assessed after administration of local anesthesia and after completion of the pulpotomy procedure.
|
Immediately after local anesthesia administration and immediately after completion of the pulpotomy procedure, during each treatment visit
|
|
Heart Rate
大体时间：Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
|
Heart rate will be measured using a pulse oximeter and recorded as beats per minute (bpm) to evaluate physiological changes associated with the anesthesia and pulpotomy procedures.
|
Immediately before local anesthesia administration and immediately after local anesthesia administration, during each treatment visit
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年4月15日
初级完成 (估计的)
2027年2月1日
研究完成 (估计的)
2027年2月26日
研究注册日期
首次提交
2026年9月3日
首先提交符合 QC 标准的
2026年9月3日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月14日
上次提交的符合 QC 标准的更新
2026年9月10日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 26.GENEL.013
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be made publicly available due to participant confidentiality and privacy considerations.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.