The Effect of Needle-free Injection System During Palatal Anesthesia

Local Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05166291
• Other study ID #: E.617498811-000-1065232
• Status: Completed
• Phase: N/A
• Start date: August 25, 2021
• Est. completion date: December 5, 2021

Study information

• Verified date: December 2021
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 5, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Local Anesthesia
• Pediatric Anesthesia

Intervention

Device:
• Comfort-in injection system
local anesthesia applyed with comfort-in injection system

Other:
• traditional anesthesia
local anesthesia applyed with dental syringe

Locations

Country	Name	City	State
Turkey	Okan University Faculty of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Okan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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