Comparison of The Computer Controlled Local Anesthesia and The Conventional Inferior Alveolar Nerve Block in Primary Molars Pulptomies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- The pain perception of the children to the device
研究概览
简要总结
• Introduction: Effective pain control is critical in pediatric dentistry. The effectiveness of pain control in children can be influenced by child characteristics .
Objectives: The Purpose of the study is to compare the pain perception and the effectiveness of anesthesia between the computer-controlled local anesthetic delivery system (CCLAD) and the traditional inferior alveolar nerve block (IANB) in pulptomies of the mandibular second primary molars.
Materials and Methodology: The study sample includes 90 healthy children who are selected randomly from the R4 electronic filing system in King Abdulaziz University Hospital (KAUH) with age range from 5-9 years. The child is required local anesthesia for pulpotomies in the mandibular second molars. The sample will be divided randomly to one of these 3 groups: group A is composed of 30 patients who will be anesthetized by the traditional IANB. Group B includes 30 patients will be anesthetized by the IANB using CCLAD. While, the remaining 30 patients will be assigned in group C and will be anesthetized by periodontal ligament injection anesthesia using the CCLAD. The pain perception levels after the injection is assessed by a Wing-Baker faces pain scale. Effectiveness of the anesthesia during each step in pulpotomy is measured using Sounds, eyes and motor (SEM) scale. After the treatment by 24 hours parents will be contacted by the telephone to ask about the presence of postoperative pain or lip biting. Statistical analysis is carried out using SPSS version 16.00.
详细描述
Ethical Consideration:
The Ethical Committee of King Abdulaziz University KAAUEC approved the study .
Subjects' selection:
The Sample includes children who are randomly selected by the R4 electronic file system in the pediatric dentistry specialty clinics at King Abdulaziz University Hospital (KAUH). A total of 2100 pediatric screening had been registered between April 2013 and November 2013 .These files will be checked for the eligible age in the study which is 5-9 years. Then, the inclusion and exclusion criteria will be checked, and the patients will be selected by systemic random sample.
Study design:
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
- 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
- •The inclusion criteria:
- •Age of the children was ranged from 5-9 years.
- •Children were healthy physically and mentally; all children had no contraindications to local anesthesia.
- •Children were assessed as being cooperative, had behavioral ratings "positive" or "definitely positive" according to the Frankl (Frankl et al 1962) behavior classification scale (appendix1).
- •Children were diagnosed with carious mandibular second primary molars that required treatment with pulpotomies.
排除标准
- •Disapproved consent.
- •Medically compromised children.
- •Uncooperative children.
研究组 & 干预措施
: This group consisted of 30 patients.
The traditional IANB injection was given according to the standard technique (Evers and Haegerstam 1981). From everyday practice, it is known that the present operator takes approximately 60 to 90 seconds to give a mandibular block
干预措施: conventional anesthesia syringe (Device)
30 IANB with Computer controlled
The IANB injection was given by a computer- regulated device performed with the STA system. The IANB injection was given according to the manufacturer's instruction (the model was used is the STA Single Tooth Anesthesia System produced by Milestone Scientific, Livingston, NJ).
干预措施: Computer controlled anesthesia (Device)
consisted of 30 periodontal anesthesia
The interligamental injection was given by computer- regulated device performed with the STA system.
干预措施: Computer controlled anesthesia (Device)
结局指标
主要结局
The pain perception of the children to the device
时间窗: 1-2 minutes
No follow up is required, the out come is measured immediately after completion of the injection
次要结局
- The effectiveness of the anesthesia(During the procedure)
研究者
DR.Khlood Baghlaf
DR
King Abdulaziz University