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Clinical Trials/NCT04653974
NCT04653974
Completed
N/A

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

Tokat Gaziosmanpasa University1 site in 1 country56 target enrollmentMarch 11, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pain
Sponsor
Tokat Gaziosmanpasa University
Enrollment
56
Locations
1
Primary Endpoint
Pain at different anesthesia methods
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 11, 2019
End Date
August 5, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Tokat Gaziosmanpasa University
Responsible Party
Principal Investigator
Principal Investigator

Halenur Altan

Associated Professor

Tokat Gaziosmanpasa University

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.

Outcomes

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.)

Study Sites (1)

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