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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04653974
Enrollment
56
Registered
2020-12-04
Start date
2019-03-11
Completion date
2019-08-05
Last updated
2020-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Children, Dental injection, Needle-free injection system, Pain, Pulpotomy

Brief 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.

Interventions

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).

Sponsors

Tokat Gaziosmanpasa University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
4 Years to 11 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged between 4-11 years * Having no developmental or systemic disorder or no history of allergy * Having positive or definitely positive cooperation level according to the Frankl Behavior Scale * Having sufficient mouth opening * Operation only on primary teeth * Having decayed teeth that require anesthesia

Exclusion criteria

* Patients younger than five years, older than 11 years, * Patients with systemic or developmental disorders * Children with an allergy history * 'Negative' or 'definitly negative' behavior rating according to the Frankl scale * Patients whose mouth opening is not sufficient for dental treatment * Operating only on permanent teeth * Teeth that are beyond the treatment stage * When pain occurred during treatment, supplemental anesthetics administrated, and these children were excluded.

Design outcomes

Primary

MeasureTime frameDescription
Pain at different anesthesia methodsafter dental treatments to 24 hourThe pain perception scores in the two anesthesia methods were assessed with Wong-Baker Pain Scale (Wong-Baker Scale is pain assessment method.It consists of 6 facial expressions that are evaluated from 0 to 10 according to the severity of the pain.)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026