Different Local Anesthesia Techniques for Mandibular Primary Molar Pulpectomy
2026年8月11日 更新者：DİLARA NİL GÜNAÇAR、Recep Tayyip Erdogan University Training and Research Hospital
Comparison of Computer-Controlled and Conventional Local Anesthesia Techniques on Dental Anxiety and Pain During Mandibular Primary Molar Pulpectomy: A Split-Mouth Randomized Clinical Trial
This study aims to compare the effects of computer-controlled local anesthesia and conventional inferior alveolar nerve block on dental anxiety and pain in children undergoing pulpectomy of mandibular primary molars. Both anesthesia techniques are routinely used in pediatric dental practice and are considered standard methods of care.
Children aged 6 to 8 years who require bilateral pulpectomy of mandibular primary molars will be included in this split-mouth randomized clinical trial. Each participant will receive both anesthesia techniques during separate treatment sessions. Dental anxiety, pain, and physiological parameters, including heart rate, blood pressure, oxygen saturation, and body temperature, will be assessed before, during, and after treatment using validated pediatric assessment scales and routine clinical measurements.
The findings of this study may help identify the anesthesia technique that provides greater comfort and reduces anxiety and pain during pediatric dental treatment, thereby improving the overall treatment experience for children.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
38
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：dilara nil günaçar
- 电话号码：+905412940104
- 邮箱：dilaranil.tomrukcu@erdogan.edu.tr
学习地点
-
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Rize Province
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Merkez、Rize Province、土耳其（türkiye）、53020
- Recep Tayyip Erdogan University
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接触：
- dilara nil günaçar
- 电话号码：05412940104
- 邮箱：dilaranil.tomrukcu@erdogan.edu.tr
-
-
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 to 8 years.
- Requiring bilateral pulpectomy treatment of mandibular primary molars.
- Frankl Behavior Rating Scale score of 3 or 4.
- American Society of Anesthesiologists (ASA) Physical Status I.
- No known allergy to local anesthetic agents.
- No previous experience with dental local anesthesia.
- No signs of acute abscess or swelling in the treatment area.
- Parent or legal guardian able to provide written informed consent and child willing to participate.
Exclusion Criteria:
- ASA Physical Status II or higher.
- Known allergy or contraindication to local anesthetic agents.
- Frankl Behavior Rating Scale score of 1 or 2.
- Children receiving psychological or psychiatric treatment.
- Physical or intellectual disabilities that could interfere with study procedures.
- Previous experience with dental local anesthesia.
- Presence of acute abscess, cellulitis, or diffuse swelling in the treatment area.
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：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Conventional Inferior Alveolar Nerve Block
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Conventional inferior alveolar nerve block administered with a standard dental syringe for mandibular primary molar pulpectomy.
A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
A conventional dental aspirating syringe was used for manual administration of the local anesthetic solution.
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有源比较器：Computer-Controlled Local Anesthesia
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A 4% articaine hydrochloride solution with epinephrine 1:100,000 was used as the local anesthetic solution in both study groups.
Computer-controlled delivery of local anesthetic for mandibular primary molar pulpectomy.
A computer-controlled local anesthetic delivery device was used to deliver the anesthetic solution at a constant, pre-programmed injection rate.
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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 |
|---|---|---|
|
Dental Anxiety
大体时间：Baseline and immediately after treatment
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Dental anxiety assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf).
Higher scores indicate higher levels of dental anxiety.
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Baseline and immediately after treatment
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Behavioral Pain During Local Anesthesia
大体时间：Immediately after local anesthetic injection
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Behavioral pain assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) scale during local anesthesia administration.
Scores range from 0 to 10, with higher scores indicating greater pain.
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Immediately after local anesthetic injection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-reported Pain
大体时间：Immediately after local anesthetic injection
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Pain assessed using the Wong-Baker FACES Pain Rating Scale immediately after treatment.
Self-reported pain assessed using the Wong-Baker FACES Pain Rating Scale (0-10) immediately after completion of pulpectomy.
Scores range from 0 to 10, with higher scores indicating greater pain intensity.
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Immediately after local anesthetic injection
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Facial Image Scale (FIS) Score
大体时间：Baseline and immediately after treatment.
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Emotional status assessed using the Facial Image Scale (FIS).
Higher scores indicate greater anxiety.
Emotional status assessed using the Facial Image Scale (FIS).
The scale ranges from 1 to 5, with 1 indicating no anxiety (very happy face) and 5 indicating severe anxiety (very unhappy face).
Higher scores indicate greater anxiety.
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Baseline and immediately after treatment.
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Heart Rate
大体时间：Baseline and during local anesthetic administration
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Heart rate measured using a pulse oximeter.
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Baseline and during local anesthetic administration
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Blood Pressure
大体时间：Baseline, during local anesthetic administration, and immediately after treatment
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Systolic and diastolic blood pressure measured with an automated monitor.
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Baseline, during local anesthetic administration, and immediately after treatment
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Peripheral Oxygen Saturation (SpO₂)
大体时间：Baseline, during local anesthetic administration, and immediately after treatment
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Peripheral oxygen saturation measured using pulse oximetry.
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Baseline, during local anesthetic administration, and immediately after treatment
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Body Temperature
大体时间：Baseline, during local anesthetic administration, and immediately after treatment
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Body temperature measured using a digital thermometer.
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Baseline, during local anesthetic administration, and immediately after treatment
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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 (估计的)
2026年8月12日
初级完成 (估计的)
2026年8月15日
研究完成 (估计的)
2026年10月15日
研究注册日期
首次提交
2026年7月8日
首先提交符合 QC 标准的
2026年7月14日
首次发布 (实际的)
2026年7月20日
研究记录更新
最后更新发布 (实际的)
2026年8月12日
上次提交的符合 QC 标准的更新
2026年8月11日
最后验证
2026年8月1日
更多信息
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.