Comparative Evaluation of A Novel Anesthetic Device vs. Conventional Infiltration in Pain Perception Among A Group of Pediatric Patients Undergoing Extraction Of Mandibular Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 主要终点
- Pain during injection
研究概览
简要总结
This clinical trial is being conducted in the Department of Pediatric Dentistry, Faculty of Dentistry, Cairo University. The purpose of the study is to compare the pain perception and comfort of children during tooth extraction when using a computer-controlled local anesthetic device (SleeperOne® 5) versus the conventional syringe infiltration technique.
Children between 3 and 5 years of age who require extraction of a maxillary primary molar will be invited to participate. Before starting, a topical anesthetic gel (benzocaine) will be applied. Then, local anesthesia will be given using either the SleeperOne® device or the traditional syringe, depending on the group assigned.
Pain during injection and extraction will be assessed using both child-friendly rating scales and independent evaluation by the dentist. Patient anxiety, heart rate, and blood pressure will also be recorded.
This study aims to provide evidence on whether computer-controlled anesthesia can reduce children's pain and anxiety compared with the conventional method, leading to a more comfortable dental experience.
The study is a randomized clinical trial and will be conducted in a single visit at the Pediatric Dentistry Outpatient Clinic, Faculty of Dentistry, Cairo University. The results may help improve pain management and patient comfort during dental treatment for children.
详细描述
This randomized clinical trial aims to evaluate and compare the pain perception and anxiety levels associated with the use of a computer-controlled local anesthetic delivery system (SleeperOne®) versus conventional local infiltration using a standard syringe in pediatric patients undergoing extraction of mandibular primary molars.
A total of 28 healthy children aged 3 to 5 years, requiring extraction of at least one mandibular primary molar, will be enrolled and randomly assigned into two parallel groups: the intervention group (SleeperOne®) and the control group (conventional syringe). Both groups will receive the same anesthetic solution: 3% Mepivacaine without vasoconstrictor. Topical anesthesia will be applied using 20% benzocaine gel before injection in all participants.
Pain management during dental treatment in children is a major concern in pediatric dentistry. Traditional infiltration anesthesia using a syringe is effective but often associated with pain, anxiety, and fear, which can negatively affect child cooperation. Computer-controlled local anesthetic delivery (CCLAD) systems, such as the SleeperOne® 5, have been developed to minimize these issues by providing a slow and steady flow of anesthesia with improved ergonomics for the operator.
This randomized clinical trial will compare pain perception during maxillary primary molar extraction in children using the SleeperOne® 5 device versus conventional infiltration with a standard dental syringe. The trial will follow a parallel design with two arms: an intervention group receiving local anesthesia via the SleeperOne® 5, and a control group receiving conventional syringe infiltration.
Participants will be children aged 3-5 years who require extraction of a maxillary primary molar. Topical anesthesia with benzocaine will be applied prior to injection in both groups. Local infiltration will then be administered using either the SleeperOne® 5 or a conventional syringe, depending on group allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children Aged between 3 to 5 years.
- •Medically fit children classified as ASA physical status I and II
- •Parents acceptance to participate in the study (informed consent)
- •Children with teeth diagnostically confirmed to require extraction
排除标准
- •Patients with an allergy to local anesthesia.
- •Uncooperative children
- •Children requiring general anesthesia
研究组 & 干预措施
Conventional Infiltration
Children will receive 3% mepivacaine with conventional syringe after 20% benzocaine
干预措施: Conventional Infiltration (Procedure)
SleeperOne® Device
Children will receive 3% mepivacaine using SleeperOne® device after 20% benzocaine.
干预措施: SleeperOne®, dental Hitec, France (Device)
结局指标
主要结局
Pain during injection
时间窗: immediately during local anesthetic injection
Pain during injection will be assessed using the Sound-Eye-Motor (SEM) pain scale, which is a validated observational scale for evaluating pain response in pediatric patients. The SEM scale consists of three components-sound, eye, and motor reaction-each scored from 1 to 4, where a lower score indicates minimal or no pain and a higher score indicates greater discomfort. The total score is interpreted to reflect the child's behavioral reaction to the injection stimulus.
次要结局
- Patient anxiety(During injection and extraction in the same clinical visit)
- Heart rate changes(within 15 minutes after injection)
- Blood pressure changes(within 15 minutes after injection)
- Soft tissue injury(Within 24 hours after the procedure.)
研究者
Ameera Alaa Eldin Abdalazim Khalifa
MSc Candidate in Pediatric Dentistry, Faculty of Dentistry, Cairo University
Cairo University