Computer Controlled Local Anesthesia in Children (STA machine)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02025140
Recruitment Status : Completed
First Posted : December 31, 2013
Last Update Posted : September 2, 2015
Information provided by (Responsible Party):
DR.Khlood Baghlaf, King Abdulaziz University

Brief 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.

Condition or disease Intervention/treatment 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

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 : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of The Computer Controlled Local Anesthesia and The Conventional Inferior Alveolar Nerve Block in Primary Molars Pulptomies
Study Start Date : September 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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
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:
  • (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:
  • (The Wand)
  • STA machine

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. The effectiveness of the anesthesia [ Time Frame: During the procedure ]
    The sound eye motor scale is used during different stages of procedure.

Other Outcome Measures:
  1. The pain related behavior [ Time Frame: 1-2 minutes ]
    The established behavior code was used during administration of the injection

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02025140

Saudi Arabia
King Abdulaziz University
Jeddah, Saudi Arabia
Sponsors and Collaborators
King Abdulaziz University
Principal Investigator: Prof Najlaa M Alamoudi, PHD King Abdulazize University

Additional Information:
Responsible Party: DR.Khlood Baghlaf, DR, King Abdulaziz University Identifier: NCT02025140     History of Changes
Other Study ID Numbers: 3
First Posted: December 31, 2013    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: September 2015

Keywords provided by DR.Khlood Baghlaf, King Abdulaziz University:
Computer controlled anesthesia (CCLAD)
pain perception
primary molars

Additional relevant MeSH terms:
Central Nervous System Depressants
Physiological Effects of Drugs