NCT05166291

The Effect of Needle-free Injection System During Palatal Anesthesia

The Effect of Needle-free Injection System Versus Traditional Anesthesia on Pain Perception During Palatal Infiltration Anesthesia in Children: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Okan University · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research with this topic on children is required.The purpose of this clinical study was to evaluate the effectiveness of the needle-free system versus traditional anesthesia on pain perception during PIA in children.The study was designed as a randomized, controlled cross-over clinical study with 48 children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary primary molars. It has been revealed that the application of a needle-free system during PIA ensured a decrease in pain perception in children.

Conditions

• Pediatric Anesthesia
• Local Anesthesia

Interventions

Type	Name	Description
DEVICE	Comfort-in injection system	local anesthesia applyed with comfort-in injection system
OTHER	traditional anesthesia	local anesthesia applyed with dental syringe

Timeline

• Start date: 2021-08-25
• Primary completion: 2021-11-30
• Completion: 2021-12-05
• First posted: 2021-12-21
• Last updated: 2022-01-11

Locations

1 site across 1 country: Turkey (Türkiye)