NCT04682080

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

Comparative Evaluation of Pain Perception With a Comfort-in Jet Injection and Convantional Dental Injection in Children: a Randomized, Split-mouth, Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Tokat Gaziosmanpasa University · Academic / Other
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain
• Local Infiltration
• Anesthesia
• Fear
• Anxiety
• Needle Phobia

Interventions

Type	Name	Description
BEHAVIORAL	Needle-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

Timeline

• Start date: 2018-06-20
• Primary completion: 2019-06-20
• Completion: 2019-06-20
• First posted: 2020-12-23
• Last updated: 2020-12-23

Locations

1 site across 1 country: Turkey (Türkiye)