Pain Perception of Needle-free System

December 20, 2020 updated by: Halenur Altan, Tokat Gaziosmanpasa University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Center
      • Tokat, Center, Turkey, 60250
        • Tokat Gaziosmanpasa University, Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Needle-free injection group
In needle-free injection techniques, 2% lidocaine with 1/80.000 epinephrine (Lidocaine, Colombia) was injected using the Comfort-In system.
Behavioral: Needle-free injection

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
Active Comparator: Dental injection group
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.
Behavioral: Needle-free injection

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
after dental treatments to 24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tokat Gaziosmanpasa University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Actual)

August 5, 2019

Study Completion (Actual)

August 5, 2019

Study Registration Dates

First Submitted

November 28, 2020

First Submitted That Met QC Criteria

November 28, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

December 23, 2020

Last Update Submitted That Met QC Criteria

December 20, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • U1111-1257-5993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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