STA machine: Computer Controlled Local Anesthesia in Children

Sponsor

King Abdulaziz University (Other)

Overall Status

Completed

CT.gov ID

NCT02025140

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

13.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Sep 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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 Names: 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

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 Names:

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

Outcome Measures

Primary Outcome Measures

The pain perception of the children to the device [1-2 minutes]
No follow up is required, the out come is measured immediately after completion of the injection

Secondary Outcome Measures

The effectiveness of the anesthesia [During the procedure]
The sound eye motor scale is used during different stages of procedure.

Other Outcome Measures

The pain related behavior [1-2 minutes]
The established behavior code was used during administration of the injection

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.