Computer Controlled Local Anesthesia in Children
Condition: Pain Perception of the New Device; The Pain Related Behavior; The Effectiveness of Anesthesia
Study type: Interventional
Phase: Phase 1

Summary: 
      • 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.
    

Detailed description: 
      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:

      This is a randomized single blind clinical trial study.
    

Intervention name(s): Computer controlled anesthesia; conventional anesthesia syringe
Intervention type(s): Device; Device
Intervention description(s): The IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD; Active control
Other intervention name(s): (The Wand); STA machine; Inferior alveolar nerve block injection
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Computer controlled anesthesia (CCLAD); pain perception; Effectiveness; primary molars; Behavior