The Effect of Needle-free Injection System During Palatal Anesthesia

Not Applicable

Completed

• Conditions: Pediatric Anesthesia; Local Anesthesia
• Interventions: Device: Comfort-in injection system; Other: traditional anesthesia

• Registration Number: NCT05166291
• Lead Sponsor: Okan University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Primary Completion: 2021-11-30
• Status Verified: 2021-12
• Study Completion: 2021-12-05
• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-21
• Last Update Submitted: 2021-12-21
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
comfort-in injection system (CIS)	Comfort-in injection system	comfort-in injection system (CIS)
traditional anesthesia (TA)	traditional anesthesia	traditional anesthesia

Primary Outcome Measures

Name	Time	Method
Wong-Baker Faces Pain Rating Scale (PRS)	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").
Face, Legg, Cry, Consolability Scale (FLACC)	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.

Trial Locations

Locations (1)

Okan University Faculty of Dentistry; 🇹🇷 Istanbul, Turkey