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N/A N=50 Randomized Treatment

Effectiveness of the Comfort-In Needle Free Injection System During Palatal Infiltrative Anesthesia

Physiological Effects of Drugs · Anesthetics

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Pain Perception Measured by the Wong-Baker FACES Pain Rating Scale — 1.04; 4.24 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Comfort-in Jet Injection Method (Device); Traditional Dental Injection (Other)
Age
Pediatric · 6+ yrs
Sex
All
Sponsor
Necmettin Erbakan University
Primary completion
Nov 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Pain Perception Measured by the Wong-Baker FACES Pain Rating Scale
1.04; 4.24
PRIMARY
Pain Perception Measured by the Face, Legs, Activity, Cry, and Consolability (FLACC) Scale
1.28; 1.64

Summary

The goal of this randomized clinical trial is to compare two different injection methods in children. The main question it aims to answer is: Is the needle-free injection method more painless than the traditional dental method? Two different methods will be used for children to perform anesthesia for extraction permanent molars.

Eligibility Criteria

Inclusion Criteria

Child patient between the ages of 6-16, Requiring extraction of maxillary permanent molars and premolars with bilateral palatal infiltration anesthesia, Showing "positive" and "definitely positive" behavior during examination according to the Frankl scale, Family volunteers, No medical or developmental disease

Exclusion Criteria

If there are medical or developmental disorders, If there is a chronic disease, If there is an allergy to anesthetic solutions, If there is any pathology in the anesthesia area, If the Frankl scale is "negative" and "definitely negative", If the mouth opening is not sufficient, If there is no need for symmetrical treatment in the teeth

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06606587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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