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Completed

NCT Number: NCT02025140

Computer Controlled Local Anesthesia in Children

• 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.

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Key information

Conditions

Pain Perception of the New Device Behavior The Effectiveness of Anesthesia The Pain Related Behavior

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

King Abdulaziz University

Jeddah, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Computer controlled anesthesia

Device

The IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD

Other names: (The Wand), STA machine

conventional anesthesia syringe

Device

Active control

Other names: Inferior alveolar nerve block injection

Primary outcomes

  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 outcomes

  1. The effectiveness of the anesthesia

    Time frame: During the procedure

    The sound eye motor scale is used during different stages of procedure.

Other outcomes

  1. The pain related behavior

    Time frame: 1-2 minutes

    The established behavior code was used during administration of the injection

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

Comparison of The Computer Controlled Local Anesthesia and The Conventional Inferior Alveolar Nerve Block in Primary Molars Pulptomies

Acronym: STA machine

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 31, 2013
Registry last updated
Sep 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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