Pain Perception of Needle-free System

Not Applicable

Completed

• Conditions: Anxiety; Needle Phobia; Pain; Dental Fear; Local Anesthesia
• Interventions: Behavioral: Needle-free injection

• Registration Number: NCT04653974
• Lead Sponsor: Tokat Gaziosmanpasa University

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.

Study Timeline

• Study Start: 2019-03-11
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-05
• Study First Submitted: 2020-11-28
• Study First Submitted QC: 2020-11-28
• Status Verified: 2020-12
• Study First Posted: 2020-12-04
• Last Update Submitted: 2020-12-20
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Needle-free injection group	Needle-free injection	In needle-free injection techniques, 2% lidocaine with 1/80.000 epinephrine (Lidocaine, Colombia) was injected using the Comfort-In system.
Dental injection group	Needle-free injection	In the conventional dental-injection method, 2% lidocaine with 1/80.000 epinephrine (Lidocaine, Colombia) was injected using a 27G, 40-mm, disposable syringe with a needle.

Primary Outcome Measures

Name	Time	Method
Pain at different anesthesia methods	after dental treatments to 24 hour	The 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.)

Trial Locations

Locations (1)

Tokat Gaziosmanpasa University, Faculty of Dentistry; 🇹🇷 Tokat, Center, Turkey