- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025140
Computer Controlled Local Anesthesia in Children (STA machine)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Jeddah, Saudi Arabia
- King Abdulaziz University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
The exclusion criteria:
- Disapproved consent.
- Medically compromised children.
- Uncooperative children.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: : 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
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Active control
Other Names:
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Experimental: 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).
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The IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD
Other Names:
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Experimental: consisted of 30 periodontal anesthesia
The interligamental injection was given by computer- regulated device performed with the STA system.
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The IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pain perception of the children to the device
Time Frame: 1-2 minutes
|
No follow up is required, the out come is measured immediately after completion of the injection
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1-2 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effectiveness of the anesthesia
Time Frame: During the procedure
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The sound eye motor scale is used during different stages of procedure.
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During the procedure
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The pain related behavior
Time Frame: 1-2 minutes
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The established behavior code was used during administration of the injection
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1-2 minutes
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prof Najlaa M Alamoudi, PHD, King Abdulazize University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3
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