Pain Perception of the New Device Clinical Trial
— STA machineOfficial title:
Comparison of The Computer Controlled Local Anesthesia and The Conventional Inferior Alveolar Nerve Block in Primary Molars Pulptomies
| Verified date | September 2015 |
| Source | King Abdulaziz University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
• 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.
| Status | Completed |
| Enrollment | 91 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 5 Years to 9 Years |
| Eligibility |
The inclusion criteria: 1. Age of the children was ranged from 5-9 years. 2. Children were healthy physically and mentally; all children had no contraindications to local anesthesia. 3. 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). 4. Children were diagnosed with carious mandibular second primary molars that required treatment with pulpotomies. The exclusion criteria: 1. Disapproved consent. 2. Medically compromised children. 3. Uncooperative children. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Saudi Arabia | King Abdulaziz University | Jeddah |
| Lead Sponsor | Collaborator |
|---|---|
| King Abdulaziz University |
Saudi Arabia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The pain related behavior | The established behavior code was used during administration of the injection | 1-2 minutes | No |
| Primary | The pain perception of the children to the device | No follow up is required, the out come is measured immediately after completion of the injection | 1-2 minutes | No |
| Secondary | The effectiveness of the anesthesia | The sound eye motor scale is used during different stages of procedure. | During the procedure | No |