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Completed

NCT Number: NCT04028271

Local Anesthesia With Needle-free Injection System

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).

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Key information

Conditions

Pediatric Anesthesia Local Anesthesia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Okan University Faculty of Dentistry

Istanbul, 34959, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Comfort-in injection system

Device

local anesthesia during dental treatment

conventional injection with dental needle

Other

for local anesthesia during dental treatment

Primary outcomes

  1. 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").

  2. 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.

Sponsors and collaborators

Lead sponsor

Sinem yildirim

Other

Registry information

Official study title

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

Acronym: anesthesia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 22, 2019
Registry last updated
Jul 22, 2019

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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