Local Anesthesia With Needle-free Injection System (anesthesia)

July 19, 2019 updated by: Sinem yildirim

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34959
        • Okan University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental
local anesthesia applyed with Comfort in system
Device: Comfort-in injection system
local anesthesia during dental treatment
Active Comparator: conventional injection
local anesthesia applyed with conventional syringe
Other: conventional injection with dental needle
for local anesthesia during dental treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wong-Baker Faces Pain Rating Scale (PRS)
Time Frame: 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").
1 year
Face, Legg, Cry, Consolability Scale (FLACC)
Time Frame: 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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sinem yildirim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

June 15, 2019

Study Registration Dates

First Submitted

July 11, 2019

First Submitted That Met QC Criteria

July 19, 2019

First Posted (Actual)

July 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 19, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018/201
  • Marmara universty (Other Identifier: Ethical Committe)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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