Local Anesthesia With Needle-free Injection System

NCT04028271 | Completed

• 2 other identifiers: 2018/201Marmara universty
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Pediatric Anesthesia; Local Anesthesia

Keywords

needle-free injection; pain

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").

  1 year

• 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

Study Arms (2)

experimental

EXPERIMENTAL

local anesthesia applyed with Comfort in system

Device: Comfort-in injection system

conventional injection

ACTIVE COMPARATOR

local anesthesia applyed with conventional syringe

Other: conventional injection with dental needle

Interventions

Comfort-in injection system DEVICE

local anesthesia during dental treatment

experimental

conventional injection with dental needle OTHER

for local anesthesia during dental treatment

conventional injection

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 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
• 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 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

Sponsors & Collaborators

• Sinem yildirim: lead

Study Sites (1)

Okan University Faculty of Dentistry

Istanbul, 34959, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Design

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

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 22, 2019
• Study Start: June 1, 2018
• Primary Completion: May 15, 2019
• Study Completion: June 15, 2019
• Last Updated: July 22, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)