Local Anesthesia With Needle-free Injection System

Sinem yildirim60 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pediatric Anesthesia Local Anesthesia

Interventions

Comfort-in injection systemDEVICE

local anesthesia during dental treatment

conventional injection with dental needleOTHER

for local anesthesia during dental treatment

Eligibility

Sex: ALLMin age: 6 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Okan University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

Wong-Baker Faces Pain Rating Scale (PRS)

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").

Time frame: 1 year

Face, Legg, Cry, Consolability Scale (FLACC)

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.

Time frame: 1 year

Data from ClinicalTrials.gov

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