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Computer Controlled Local Anesthesia in Children (STA machine)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by King Abdulaziz University
Sponsor:
Information provided by (Responsible Party):
DR.Khlood Baghlaf, King Abdulaziz University
ClinicalTrials.gov Identifier:
NCT02025140
First received: November 25, 2013
Last updated: December 30, 2013
Last verified: December 2013
  Purpose

• 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.


Condition Intervention Phase
Pain Perception of the New Device
The Pain Related Behavior
The Effectiveness of Anesthesia
Device: Computer controlled anesthesia
Device: conventional anesthesia syringe
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Comparison of The Computer Controlled Local Anesthesia and The Conventional Inferior Alveolar Nerve Block in Primary Molars Pulptomies

Resource links provided by NLM:


Further study details as provided by King Abdulaziz University:

Primary Outcome Measures:
  • The pain perception of the children to the device [ Time Frame: 1-2 minutes ] [ Designated as safety issue: No ]
    No follow up is required, the out come is measured immediately after completion of the injection


Secondary Outcome Measures:
  • The effectiveness of the anesthesia [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
    The sound eye motor scale is used during different stages of procedure.


Other Outcome Measures:
  • The pain related behavior [ Time Frame: 1-2 minutes ] [ Designated as safety issue: No ]
    The established behavior code was used during administration of the injection


Estimated Enrollment: 90
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Device: conventional anesthesia syringe
Active control
Other Name: Inferior alveolar nerve block injection
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).
Device: Computer controlled anesthesia
The IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD
Other Names:
  • Computer controlled anesthesia
  • (The Wand)
  • STA machine
Experimental: consisted of 30 periodontal anesthesia
The interligamental injection was given by computer- regulated device performed with the STA system.
Device: Computer controlled anesthesia
The IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD
Other Names:
  • Computer controlled anesthesia
  • (The Wand)
  • STA machine

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.

  Eligibility

Ages Eligible for Study:   5 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025140

Locations
Saudi Arabia
King Abdulaziz University Recruiting
Jeddah, Saudi Arabia
Contact: Khlood Baghlaf    009660216410000      
Principal Investigator: Prof. Najlaa M Alamoudi, PHD         
Sub-Investigator: Dr.Khlood K Baghlaf, BDS         
Sub-Investigator: DR.Eman A El Ashiray, PHD         
Sub-Investigator: Prof.Douaa A El Derwi, PHD         
Sponsors and Collaborators
King Abdulaziz University
Investigators
Principal Investigator: Prof Najlaa M Alamoudi, PHD King Abdulazize University
  More Information

No publications provided

Responsible Party: DR.Khlood Baghlaf, DR, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT02025140     History of Changes
Other Study ID Numbers: 3
Study First Received: November 25, 2013
Last Updated: December 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by King Abdulaziz University:
Computer controlled anesthesia (CCLAD)
pain perception
Effectiveness
primary molars
Behavior

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014