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Clinical Trials/NCT04028271
NCT04028271
Completed
N/A

Comparision of Injection Pain Caused by the 'Comfort in' Injection System Versus a Traditional Syringe for Inferior Alveolar Nerve Block Anaesthesia in Primary Teeth

Sinem yildirim1 site in 1 country60 target enrollmentJune 1, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pediatric Anesthesia
Sponsor
Sinem yildirim
Enrollment
60
Locations
1
Primary Endpoint
Wong-Baker Faces Pain Rating Scale (PRS)
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

The purpose of this study was to compare the pain during needle insertion and injection in mandibular molars anesthetized with either traditional syringe (control) or Comfort in System (experimental).

Registry
clinicaltrials.gov
Start Date
June 1, 2018
End Date
June 15, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Sinem yildirim
Responsible Party
Sponsor Investigator
Principal Investigator

Sinem yildirim

Assistant Professor

Okan University

Eligibility Criteria

Inclusion Criteria

  • In need of treatment of right and left molar teeth of mandible,
  • Does not have any systemic disorder,
  • High level of communication that can provide logical answers to the questions we ask
  • With parental consent,
  • Volunteers who want to participate in the research
  • 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria

  • No need for treatment of right and left molar teeth of mandible,
  • Has a systemic condition
  • Low level of communication that cannot provide reasonable answers to the questions we ask
  • Without parental consent
  • Do not want to participate voluntarily in the research
  • Do not attend a check-in
  • Patients not in the 6-12 age group

Outcomes

Primary Outcomes

Wong-Baker Faces Pain Rating Scale (PRS)

Time Frame: 1 year

The PRS measures the unpleasantness or affective dimension of a child's pain experience and is used in children aged 3-17 years old. The PRS consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears, and each child is asked to select the facial expression that best represents his/her experience of discomfort. Each face has a numerical value ranging from 0 (smiling face, "no hurt") to 5 (crying/screaming face, "hurts worst").

Face, Legg, Cry, Consolability Scale (FLACC)

Time Frame: 1 year

The scale comprised the following parameters: (1) Face, (2) Legs, (3) Activity, (4) Cry, and (5) Consolability. Each of the five categories is scored from 0-2, which results in a minimum total score of 0 and maximumof 10. According to this scale: 0=Relaxed and comfortable (no pain); 1-3=Mild discomfort; 4-6=Moderate pain; and 7-10=Severe discomfort or pain \[Willis et al., 2003\]. Behavioural parameters were recorded.

Study Sites (1)

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