Pain Perception of Needle-free System

Tokat Gaziosmanpasa University

Status: Completed

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

Treatments: Behavioral: Needle-free injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04653974

U1111-1257-5993

Details and patient eligibility

About

The purpose of this study is to evaluate and compare the pain perception associated with a needle-free injection system( Comfort-In) and dental injection method in filling and pulpotomy treatments

Full description

Needle-free injection system(Comfort-In) and dental injection method was applied on the teeth of children who need dental treatment.70 patients were included in the study. 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, during treatment and at the end of thetreatment by the Wong Baker Faces Pain Scale.

The datas were analyzed with a three-way variance method in repeated.

Enrollment: 56 patients

Sex: All

Ages: 4 to 11 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged between 4-11 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 five years, older than 11 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)

---

56 participants in 2 patient groups

Needle-free injection group

Active Comparator group

Description:

In needle-free injection techniques, 2% lidocaine with 1/80.000 epinephrine (Lidocaine, Colombia) was injected using the Comfort-In system.

Treatment:

Behavioral: Needle-free injection

Dental injection group

Active Comparator group

Description:

In the conventional dental-injection method, 2% lidocaine with 1/80.000 epinephrine (Lidocaine, Colombia) was injected using a 27G, 40-mm, disposable syringe with a needle.

Treatment:

Behavioral: Needle-free injection