Anesthesia, Anxiety, Fear, Local Infiltration, Needle Phobia, Pain
Conditions
Keywords
Comfort-in jet injection system, needle-free injection, dental pain, dental anxiety and fear, color of pain
Brief summary
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
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.
Interventions
BEHAVIORALNeedle-free injection
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
Sponsors
Tokat Gaziosmanpasa University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 10 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Children's preferred anesthesia method | After using each dental injection method(2 weeks). | Children's preferred anesthesia method was asked for children after two different injection tecniques used. |
| 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. 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). |
| Anxiety level of children | after dental treatments(40 minutes) | 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. |
| Color of pain during anesthesia. | immediately after injection(2 minutes), | 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) |
Countries
Turkey (Türkiye)
Outcome results
None listed