Local Anesthesia With Needle-free Injection System

Not Applicable

Completed

• Conditions: Pediatric Anesthesia; Local Anesthesia
• Interventions: Device: Comfort-in injection system; Other: conventional injection with dental needle

• Registration Number: NCT04028271
• Lead Sponsor: Sinem yildirim

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-05-15
• Study Completion: 2019-06-15
• Status Verified: 2019-07
• Study First Submitted: 2019-07-11
• Study First Submitted QC: 2019-07-19
• Last Update Submitted: 2019-07-19
• Study First Posted: 2019-07-22
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
experimental	Comfort-in injection system	local anesthesia applyed with Comfort in system
conventional injection	conventional injection with dental needle	local anesthesia applyed with conventional syringe

Primary Outcome Measures

Name	Time	Method
Wong-Baker Faces Pain Rating Scale (PRS)	1 year	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)	1 year	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