Pain Perception With a Comfort-ın Jet Injection and Conventional Dental Injection

Study Overview
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Brief Summary
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The investigators aimed to compare the effectiveness of the Comfort-in system, which is a jet injection type, and infiltrative anesthesia with a traditional injector, and to measure the effect of children's anxiety on the severity of pain.

Detailed Description
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Among the children between the ages of 4 and 10 who were admitted to clinic between 2018-2020, whose clinical and radiographic examinations were completed; Patients with deciduous teeth that needed the same dental treatment (filling or amputation) with symmetrical local anesthesia application and positive (3) or definitely positive (4) according to the Frankl Behavior Evaluation Scale were included in the study. In study with a split-mouth design, infiltration anesthesia was applied with a conventional dental injector to one of the symmetrical teeth requiring the same treatment, while the Comfort-in jet injection system was applied to the other by the same physician. 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(Pain 1), during treatment(Pain 2), at the end of the treatment(Pain 3) and on the postoperative 1st day (Pain 4)by the specially 7 colors (white, yellow, green, blue, magenta, red, black) using the Wong-Baker facial expressions and pain grading scale.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version. The data were analyzed by IBM SPSS Statistics 19, the significance level was taken as p <0.05.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 Comfort-in Jet Injection and Convantional Dental Injection in Children: a Randomized, Split-mouth, Clinical Trial

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

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 4-10 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 four years, older than 10 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: 10 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, 4% articaine with 1/100.000 epinephrine (Ultracaine DS forte) was injected using the Comfort-In system. Pain intensity and anxiety levels of patients were measured. | Behavioral: Needle-free injection<br>* This study was performed among children aged 4-10 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 120 patients were evaluated in accordance with the exclusion criteria and 94 children (39 girls and 55 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 colorful Wong-Baker Pain Scale at four time points: immediately after injection (Pain 1), during treatment (Pain 2), at the end of the treatment (Pain 3) and postoperative first day.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version<br>* Other names: Dental injection;|
| Active Comparator: Dental injection group<br>In the conventional dental-injection method, 4% articaine with 1/100.000 epinephrine (Ultracaine DS forte) was injected using a 27G, 50-mm, disposable syringe with a needle. Pain intensity and anxiety levels of patients were measured. | Behavioral: Needle-free injection<br>* This study was performed among children aged 4-10 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 120 patients were evaluated in accordance with the exclusion criteria and 94 children (39 girls and 55 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 colorful Wong-Baker Pain Scale at four time points: immediately after injection (Pain 1), during treatment (Pain 2), at the end of the treatment (Pain 3) and postoperative first day.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version<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. Values between 0-4 indicate mild pain, values between 4-6 indicate moderate pain, values between 6-8 indicate severe pain and values between 8-10 indicate unbearable pain). | after dental treatments to 24 hour | 
| Anxiety level of children | Anxiety level of children were assesed with Modified Child Dental Anxiety Scale (Modified Child Dental Anxiety Scale is anxiety assessment method. It consist of 8 questions about dental procedures. Each questions are evaluated 5 faces from smiles to cries according to the severity of tne anxiety. Patients with a Modified Child Dental Anxiety Scale value below 26 have less anxiety, and patients with a value of 26 and above have a high level of anxiety. | after dental treatments(40 minutes) | 
| Color of pain during anesthesia. | The pain perception scores in the two anesthesia methods were assessed with 7 colorful (white,yellow, green, blue, purple, red and black) 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. Values between 0-4 indicate mild pain, values between 4-6 indicate moderate pain, values between 6-8 indicate severe pain and values between 8-10 indicate unbearable pain) | immediately after injection(2 minutes), | 
| Children's preferred anesthesia method | Children's preferred anesthesia method was asked for children after two different injection tecniques used. | After using each dental injection method(2 weeks). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Comfort-in jet injection system, needle-free injection, dental pain, dental anxiety and fear, color of pain