Comparative Evaluation of Pain Perception With a Comfort-in Jet Injection and Convantional Dental Injection in Children: a Randomized, Split-mouth, Clinical Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Tokat Gaziosmanpasa University
- Enrollment
- 94
- Locations
- 1
- Primary Endpoint
- Pain at different anesthesia methods
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Halenur Altan
Associated Professor
Tokat Gaziosmanpasa University
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Pain at different anesthesia methods
Time Frame: 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
Time Frame: 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.
Time Frame: 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)
Children's preferred anesthesia method
Time Frame: After using each dental injection method(2 weeks).
Children's preferred anesthesia method was asked for children after two different injection tecniques used.