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

Tokat Gaziosmanpasa University

Status: Completed

Conditions: Fear; Local Infiltration; Needle Phobia; Anxiety; Pain; Anesthesia

Treatments: Behavioral: Needle-free injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04682080

2018/33

Details and patient eligibility

About

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.

Full 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.

Enrollment: 94 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Needle-free injection group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Needle-free injection

Dental injection group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Needle-free injection