ClinicalTrials.Veeva

Menu

The Effect of Needle-free Injection System During Palatal Anesthesia

O

Okan University

Status

Completed

Conditions

Local Anesthesia
Pediatric Anesthesia

Treatments

Device: Comfort-in injection system
Other: traditional anesthesia

Study type

Interventional

Funder types

Other

Identifiers

NCT05166291
E.617498811-000-1065232

Details and patient eligibility

About

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.

Enrollment

48 patients

Sex

All

Ages

6 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • In need of treatment of right and left primary molar teeth of maxilla,
  • Does not have any systemic disorder,
  • High level of communication that can provide logical answers to the questions we ask
  • With parental consent,
  • Volunteers who want to participate in the research
  • 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion criteria

  • No need for treatment of right and left primary molar teeth of maxilla,
  • Has a systemic condition
  • Low level of communication that cannot provide reasonable answers to the questions we ask
  • Without parental consent
  • Do not want to participate voluntarily in the research
  • Do not attend a check-in
  • Patients not in the 6-12 age group

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

48 participants in 2 patient groups

traditional anesthesia (TA)
Experimental group
Description:
traditional anesthesia
Treatment:
Other: traditional anesthesia
comfort-in injection system (CIS)
Experimental group
Description:
comfort-in injection system (CIS)
Treatment:
Device: Comfort-in injection system

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems