Pain Perception of the New Device Clinical Trial
Official title:
Comparison of The Computer Controlled Local Anesthesia and The Conventional Inferior Alveolar Nerve Block in Primary Molars Pulptomies
• 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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment