Clinical trial NCT04653974: Pain Perception of Needle-free System
Official title: Comparative Evaluation of Pain Perception With a New Needle-Free System and Dental Injection in Children: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Needle Phobia
Anxiety
Dental Fear
Local Anesthesia
Keywords: Children
Dental injection
Needle-free injection system
Pain
Pulpotomy
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 56
Sex: ALL
Minimum age (years): 4
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain at different anesthesia methods
timeFrame: after dental treatments to 24 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University, Faculty of Dentistry
state: Center
Study officials:
affiliation: Tokat Gaziosmanpasa University, Faculty of Dentistry, Department of Pediatric Dentistry
name: Halenur Altan, Assoc Prof.
role: PRINCIPAL_INVESTIGATOR
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