Evaluation of Pain Perception Using Computer-Controlled Local Anaesthesia Delivery With Different Injection Speeds Versus Conventional Anaesthesia for Maxillary Primary Molars: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Wong-Baker Subjective Pain Perception During Local Anesthesia Injection
研究概览
简要总结
This clinical trial aims to compare pain perception in children during dental procedures when using a computer-controlled local anesthesia device versus a traditional syringe. Children aged 6 to 8 years who need maxillary primary molar extraction will be randomly assigned to one of four groups: three groups using different speeds of the GENI computer-controlled device, and one group using a conventional syringe. The study will assess pain using facial expression scales and physiological measures such as heart rate. The goal is to find a more comfortable method for delivering anesthesia to pediatric dental patients.
详细描述
This is a parallel-design randomized controlled clinical trial evaluating pain perception during local anesthesia administration in children undergoing extraction of maxillary primary molars. The study compares the use of a computer-controlled local anesthesia delivery system (GENI) at three different injection speeds-high, moderate, and low-with conventional syringe-based anesthesia.
Children aged 6 to 8 years who meet the inclusion criteria will be randomly allocated to one of four groups using a computer-generated randomization sequence. Standardized injection techniques will be applied in all groups. The primary outcome is subjective pain, assessed using the Wong-Baker FACES Pain Rating Scale. Secondary outcomes include objective behavioral pain assessments using the FLACC scale and physiological responses such as heart rate and oxygen saturation measured with a pulse oximeter.
All procedures will be performed by a single trained operator. The assistant supervisor will monitor randomization and data collection. Although blinding of the operator and participants is not feasible due to the nature of the devices, outcome assessors and the statistician will remain blinded to group assignment to reduce bias.
The study aims to identify whether the GENI device provides improved comfort, reduced pain, and greater cooperation among pediatric patients compared to traditional local anesthesia techniques. The results are expected to guide the development of better pain management strategies in pediatric dentistry.
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
- 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 from 6 to 8 years old
- •Both sexes
- •Healthy children classified as ASA I
- •Children with maxillary primary molars indicated for extraction
- •No previous dental experience
- •Mentally capable of communication and following instructions
- •No acute dental pain
排除标准
- •Uncooperative children or those with a behavioral management problem (Frankl rating 1 or 2)
- •Children with known allergies to the local anesthetic or dental materials used in the study
- •Children taking medications (e.g., antibiotics, analgesics) in the previous 48 hours that may alter pain perception
- •Children whose parents or legal guardians refuse to sign the informed consent form
- •Children experiencing acute dental pain
研究组 & 干预措施
GENI High-Speed Injection
Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to high-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized technique. Pain perception will be evaluated immediately after injection.
干预措施: GENI High-Speed Injection (Device)
GENI Moderate-Speed Injection
Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to moderate-speed injection mode. The injection will include buccal and intrapapillary infiltration using 4% articaine with 1:100,000 epinephrine. The procedure will be performed by the principal investigator using a standardized technique. Pain perception will be assessed immediately following the injection.
干预措施: GENI Moderate-Speed Injection (Device)
GENI Low-Speed Injection
Participants in this arm will receive local anesthesia using the GENI computer-controlled local anesthesia delivery (CCLAD) device set to low-speed injection mode. Buccal and intrapapillary infiltration will be administered using 4% articaine with 1:100,000 epinephrine. The injection will be performed by the principal investigator following a standardized protocol. Pain perception will be evaluated using subjective, objective, and physiological measures.
干预措施: GENI Low-Speed Injection (Device)
A Conventional dental Syringe
Participants in this arm will receive local anesthesia using a traditional metal aspirating dental syringe (C-K JECT) with a short 30-gauge needle. Buccal and intrapapillary infiltration will be performed using 4% articaine with 1:100,000 epinephrine, following a standardized injection technique. The procedure will be conducted by the principal investigator. Pain perception will be assessed immediately after the injection using subjective, objective, and physiological parameters.
干预措施: A conventional dental syringe (Device)
结局指标
主要结局
Wong-Baker Subjective Pain Perception During Local Anesthesia Injection
时间窗: Immediately after local anesthesia injection
Pain perception will be measured using the Wong-Baker FACES Pain Rating Scale, which ranges from 0 (no pain) to 10 (worst pain). Each child will select the face that best represents their level of pain immediately following the injection. This scale is a validated tool for assessing subjective pain in pediatric patients.
次要结局
- Objective Pain Perception During local anathesia Injection (FLACC Scale)(During local anesthesia injection(Day 1))
- Heart rate Response to Local Anesthesia injection(Baseline (within 10 minutes before injection )and during injection (Day 1))
- Oxygen Saturation During Local Anesthesia injection(Baseline (within 10 minutes before injection ) and during injection (Day 1))
研究者
Tarek MHD kher al saka amini
DOCTOR
Cairo University