Comparison of Computer Controlled Intra-ligamentary Local Anesthesia and Conventional Inferior Alveolar Nerve Block in Primary Molars Extractions - Randomized Clinical Trail
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
The goal of this clinical trial is to assess pain perception, child stress level and compare the effectiveness between periodontal ligament anesthesia using Computer-controlled Local Anesthetic delivery system and the Conventional Inferior Alveolar Nerve Block during extraction of the primary molars.
The main questions it aims to answer are:
Is there a difference in pain perception, child stress level and anesthesia effectiveness between the CC-ILA system and the traditional syringe when administering IANB in pediatric patients undergoing primary molar extractions.
Researchers will compare CC-ILA system to traditional syringe when administering IANB to see if there a difference in pain perception, child stress level and anesthesia effectiveness.
Participants will:
Have their lower first primary molar extracted by receiving either periodontal ligament anesthesia using computer-controlled local anesthetic delivery system or the conventional inferior alveolar nerve bock.
Pain perception during the anesthesia process was measured using both objective criteria through the Sound-Eye-Motor scale and subjective assessment using Wong-Baker Faces Pain Rating Scale. Salivary cortisol level will be used to determine child stress level. The efficacy of anesthesia at various stages of the extraction procedure was evaluated using the Sound-Eye-Motor scale.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 5 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy children (ASA I).
- •Ranging in age from 5-
- •Cooperative (Frankle ++).
- •With mandibular first primary molars earmarked for removal owing to factors such as: extensive caries, crown damage, periapical lesions and unsuccessful pulp treatment.
排除标准
- •Mobile teeth (Grade III).
- •Ankylosed teeth.
- •Teeth with root resorption (more than 1\3).
- •Patients with facial cellulitis and when there is a need for supplemental anesthesia
研究组 & 干预措施
Conventional Inferior Alveolar nerve block
干预措施: Inferior Alveolar Nerve Block (Procedure)
Computer-controlled Intraligamentary local anaesthesia
干预措施: Computer-controlled Local Anesthetic delivery system (Device)
结局指标
主要结局
Pain
时间窗: Immediately after receiving anesthesia
Wong-Baker Faces Pain Rating Scale The scale contains a series of six faces ranging from a happy face at 0 to indicate "no hurt" to a crying face at 10 to indicate "hurts worst".
Stress level
时间窗: Before and after local anesthesia delivery
Child stress level after receiving either of anesthesia will be determined using salivary cortisol which will be collected by cortisol ELISA kit
Effectiveness
时间窗: Through dental procedure
Sound eye motor scale An observational scale uses child sound, eye and body movement to reflect on child comfort where score 1 reflect "comfort" and score 4 reflect "pain"
次要结局
未报告次要终点
研究者
Lamia Saleh AlGhamdi
Pediatric Dentist
King Abdulaziz University