NCT04653974

Pain Perception of Needle-free System

Comparative Evaluation of Pain Perception With a New Needle-Free System and Dental Injection in Children: A Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Tokat Gaziosmanpasa University · Academic / Other
• Sex: All
• Age: 4 Years – 11 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate and compare the pain perception associated with a needle-free injection system( Comfort-In) and dental injection method in filling and pulpotomy treatments

Detailed description

Needle-free injection system(Comfort-In) and dental injection method was applied on the teeth of children who need dental treatment.70 patients were included in the study. Patients were randomized into two grups according to the injection technique. Group1: Needle-free injection system(Comofrt-In) 2:Dental injection method. The pain intensity was assessed during anesthesia, during treatment and at the end of thetreatment by the Wong Baker Faces Pain Scale. The datas were analyzed with a three-way variance method in repeated.

Conditions

• Pain
• Needle Phobia
• Anxiety
• Dental Fear
• Local Anesthesia

Interventions

Type	Name	Description
BEHAVIORAL	Needle-free injection	This study was performed among children aged 4-11 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 70 patients were evaluated in accordance with the exclusion criteria and 56 children (31 girls and 25 boys) were included in this study. Children who needed dental treatment were randomly divided into two groups. All dental injections were administered by the same operator (MB), a pediatric dentist with two years of experience in using the Comfort-In system. In both groups, the children were asked to rate their pain intensity by choosing the closest statement on the Wong-Baker Pain Scale at three time points: immediately after injection (Pain 1), during treatment (Pain 2), and at the end of the treatment (Pain 3).

Timeline

• Start date: 2019-03-11
• Primary completion: 2019-08-05
• Completion: 2019-08-05
• First posted: 2020-12-04
• Last updated: 2020-12-23

Locations

1 site across 1 country: Turkey (Türkiye)