CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
Needle-free injectionbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04653974
NCT04653974N/ACompleted
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Comparative Evaluation of Pain Perception With a New Needle-Free System and Dental Injection in Children: A Randomized Clinical Trial

Tokat Gaziosmanpasa University·interventional·Posted Dec 4, 2020·Updated Dec 23, 2020

In Brief

A clinical study evaluating Needle-free injection for Pain and 4 related conditions. Completed, enrolled 56 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain, Needle Phobia, Anxiety, Dental Fear, Local Anesthesia
CountriesTurkey (Türkiye)
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedDec 4, 2020
Enrollment StartMar 11, 2019
Primary CompletionAug 5, 2019
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 5.6 years ago

Interventions

Needle-free injectionbehavioral

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).