The Effect of Needle-free Injection System During Palatal Anesthesia

NCT05166291 | Completed

• 1 other identifier: E.617498811-000-1065232
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Anesthesia; Local Anesthesia

Keywords

needle-free injection system; pain perception

Outcome Measures

Primary Outcomes (2)

• 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").

  3 months

• 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.

  3 months

Study Arms (2)

traditional anesthesia (TA)

EXPERIMENTAL

traditional anesthesia

Other: traditional anesthesia

comfort-in injection system (CIS)

EXPERIMENTAL

comfort-in injection system (CIS)

Device: Comfort-in injection system

Interventions

Comfort-in injection system DEVICE

local anesthesia applyed with comfort-in injection system

Also known as: dental syringe

comfort-in injection system (CIS)

traditional anesthesia OTHER

local anesthesia applyed with dental syringe

traditional anesthesia (TA)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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
• years old patients who are compatible with routine dental treatments in the pediatric clinic

You may not qualify if:

• 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

Sponsors & Collaborators

• Okan University: lead

Study Sites (1)

Okan University Faculty of Dentistry

Istanbul, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 21, 2021
• Study Start: August 25, 2021
• Primary Completion: November 30, 2021
• Study Completion: December 5, 2021
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)