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Local Anesthesia With Needle-free Injection System

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04028271
Acronym
anesthesia
Enrollment
60
Registered
2019-07-22
Start date
2018-06-01
Completion date
2019-06-15
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia, Pediatric Anesthesia

Keywords

needle-free injection, pain

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).

Interventions

local anesthesia during dental treatment

OTHERconventional injection with dental needle

for local anesthesia during dental treatment

Sponsors

Sinem yildirim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026