Local Anesthesia With Needle-free Injection System

Local Anesthesia Clinical Trial

— anesthesia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04028271
• Other study ID #: 2018/201
• Secondary ID: Marmara universt
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: June 15, 2019

Study information

• Verified date: July 2019
• Source: Okan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 15, 2019
• Est. primary completion date: May 15, 2019
• 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 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

Related Conditions & MeSH terms

• Local Anesthesia
• Pediatric Anesthesia

Intervention

Device:
• Comfort-in injection system
local anesthesia during dental treatment

Other:
• conventional injection with dental needle
for local anesthesia during dental treatment

Locations

Country	Name	City	State
Turkey	Okan University Faculty of Dentistry	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Sinem yildirim

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").	1 year
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.	1 year