The Effect of Needle-free Injection System on Dental Injection Pain in Children

NACompletedINTERVENTIONAL
Enrollment

28

Participants

Timeline

Start Date

April 10, 2017

Primary Completion Date

October 10, 2017

Study Completion Date

April 10, 2018

Conditions
Anesthesia, LocalChild BehaviorPain
Interventions
DEVICE

Injection with the needle-free (NF) system

Before the injection procedure, the children were demonstrated the popping sound produced by device to prevent reflex reactions, and they informed that they would feel as if their gum were punched. The NF injection device was prepared according to the manufacturer's instructions, placed in full contact with the buccal mucosa and a pre-withdrawn dose of 0.1 ml was applied to the buccal region for topical purposes by the pushing the top of the device. After 10-15 seconds, the same procedure was repeated with withdrawn dose of 0.3 ml. After 5 min the treatment commenced, and the children were instructed to raise their hand if they experienced pain during the procedure. Each time the child indicated pain, in accordance with the same protocol an additional 0.3 ml of anesthetic solution was administered, until the sufficient anesthetic effect was obtained and the final amount of anesthetic solution were recorded. Precautions were taken to prevent tissue ballooning.

DEVICE

Injection with the traditional method (TM)

The depth of penetration was only a few millimeters and 0.3ml of anesthetic solution was deposited. After 5 min the treatment commenced, and the children were instructed to raise their hand if they experienced pain during the procedure. Each time the child indicated pain, in accordance with the same protocol an additional 0.3 ml of anesthetic solution was administered, until the sufficient anesthetic effect was obtained and the final amount of anesthetic solution were recorded. Precautions were taken to prevent tissue ballooning.

Trial Locations (1)

34854

Marmara University School of Dentistry, Istanbul

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Marmara University

OTHER