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Completed

NCT Number: NCT05166291

The Effect of Needle-free Injection System During Palatal Anesthesia

Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research with this topic on children is required.The purpose of this clinical study was to evaluate the effectiveness of the needle-free system versus traditional anesthesia on pain perception during PIA in children.The study was designed as a randomized, controlled cross-over clinical study with 48 children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary primary molars. It has been revealed that the application of a needle-free system during PIA ensured a decrease in pain perception in children.

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Key information

Conditions

Pediatric Anesthesia Local Anesthesia

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Okan University Faculty of Dentistry

Istanbul, 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 primary molar teeth of maxilla,
  • 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 primary molar teeth of maxilla,
  • 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 applyed with comfort-in injection system

Other names: dental syringe

traditional anesthesia

Other

local anesthesia applyed with dental syringe

Primary outcomes

  1. Wong-Baker Faces Pain Rating Scale (PRS)

    Time frame: 3 months

    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: 3 months

    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

Okan University

Other

Registry information

Official study title

The Effect of Needle-free Injection System Versus Traditional Anesthesia on Pain Perception During Palatal Infiltration Anesthesia in Children: a Randomized Clinical Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2021
Registry last updated
Jan 11, 2022

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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