Comparison of Intraosseous Anesthesia and Inferior Alveolar Nerve Block for Primary Mandibular Molars: A Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pain Intensity Measured by Visual Analog Scale (VAS)
研究概览
简要总结
The aim of the present study is to compare computerized intra-osseous injection system to the conventional inferior alveolar nerve block in primary mandibular teeth.
详细描述
This study is designed as a randomized controlled clinical trial. A total of 60 primary mandibular molars from 30 pediatric patients who present for routine dental treatment at the Department of Pediatric Dentistry, Faculty of Dentistry, Sivas Cumhuriyet University, will be included. The study will consist of two sessions for each patient, with the type of anesthesia determined through simple randomization. In one session, traditional inferior alveolar nerve block anesthesia will be administered using a traditional syringe, and in the other session, intraosseous anesthesia will be performed using the computer-controlled SleeperOne5 device.
During anesthesia administration, pain levels will be assessed using the Visual Analog Scale (VAS), patient satisfaction will be evaluated with the Facial Image Scale (FIS), and behavior will be scored using the Modified Venham Scale. Additionally, heart rate, the volume of anesthetic solution used, and onset time of anesthesia will be recorded for both techniques. Postoperative complications will be assessed one day after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6 to 8 years
- •Systemically healthy (American Society of Anesthesiologists [ASA] physical status I)
- •Positive or definitely positive behavior (Frankl Behavior Rating Scale score 3 or 4)
- •Bilateral (contralateral) mandibular primary molars with deep dentin caries requiring treatment
- •Able to attend a second appointment
- •Written informed consent from a parent/legal guardian and assent from the child
排除标准
- •Known allergy to local anesthetic solutions
- •Use of analgesics within the last 24 hours
- •Acute infection
- •Gingivitis, oral fistula, abscess, or bone loss in the area where anesthesia will be administered
研究组 & 干预措施
inferior alveolar nerve block
Conventional inferior alvoelar nerve block anaesthesia will be given using a traditional metal syringe
干预措施: Inferior Alveolar Nerve Block (Other)
intraosseous anaesthesia
Computerized intraosseous anesthesia administration using SleeperOne5
干预措施: intraosseous anaesthesia (Other)
结局指标
主要结局
Pain Intensity Measured by Visual Analog Scale (VAS)
时间窗: Immediately after anesthetic injection and during dental treatment (Day 1)
Pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst possible pain). Scores range from 0 to 10, with higher scores indicating greater pain.
次要结局
- Heart Rate(Immediately before injection (baseline), during injection, and immediately after injection (Day 1))
- Dental Anxiety and Behavior Measured by Venham Clinical Anxiety Rating Scale(Immediately after anesthetic injection and during dental treatment (Day 1))
研究者
Arzu Koçkanat
Assistant Professor
Cumhuriyet University