Pain Perception of Needle-free System

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparative Evaluation of Pain Perception With a New Needle-Free System and Dental Injection in Children: A Randomized Clinical Trial

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

Intervention / Treatment
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* Behavioral: Needle-free injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Needle-free injection group<br>In needle-free injection techniques, 2% lidocaine with 1/80.000 epinephrine (Lidocaine, Colombia) was injected using the Comfort-In system. | Behavioral: Needle-free injection<br>* 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).<br>* Other names: Dental injection;|
| Active Comparator: Dental injection group<br>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. | Behavioral: Needle-free injection<br>* 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).<br>* Other names: Dental injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain at different anesthesia methods | 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.) | after dental treatments to 24 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children, Dental injection, Needle-free injection system, Pain, Pulpotomy