Pain Perception of Needle-free System | Clinical Trial

Key information

Conditions

Pain Anxiety Anxiety Disorders Dental Fear Local Anesthesia Mental Disorders Needle Phobia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tokat Gaziosmanpasa University, Faculty of Dentistry

Tokat Province, Center, 60250, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Needle-free injection

Behavioral

This study was performed among children aged 4-11 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 70 patients were evaluated in accordance with the exclusion criteria and 56 children (31 girls and 25 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 Wong-Baker Pain Scale at three time points: immediately after injection (Pain 1), during treatment (Pain 2), and at the end of the treatment (Pain 3).

Other names: Dental injection

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.)

Sponsors and collaborators

Lead sponsor

Tokat Gaziosmanpasa University

Other

Registry information

Official study title

Comparative Evaluation of Pain Perception With a New Needle-Free System and Dental Injection in Children: A Randomized Clinical Trial

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Dec 4, 2020
Registry last updated: Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed