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The Effect of Needle-free Injection System During Palatal Anesthesia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05166291
Enrollment
48
Registered
2021-12-21
Start date
2021-08-25
Completion date
2021-12-05
Last updated
2022-01-11

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 system, pain perception

Brief summary

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.

Interventions

local anesthesia applyed with comfort-in injection system

OTHERtraditional anesthesia

local anesthesia applyed with dental syringe

Sponsors

Okan University
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 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

Design outcomes

Primary

MeasureTime frameDescription
Wong-Baker Faces Pain Rating Scale (PRS)3 monthsThe 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)3 monthsThe 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