Child Behavior After Local Anesthetic Injection Using Needless Systems

September 9, 2023 updated by: Ayatallah Elsayed Mohamed Aly Bassiouny, Cairo University

Assessment of Child Behavior and Soft Tissue Reaction After Local Anesthetic Injection Using Needle Versus Needless Systems

The aim of this study is to evaluate the effect of needless injection (comfort in ject) on child behavior and its effect on adjacent oral mucosa and soft tissue in children during local anesthesia injection in comparison to the conventional injection technique

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

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

  • Egypt
      • Cairo, Egypt, 11553
        • Faculty of Dentistry, Cairo University, Cairo, Egypt

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 8 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • According to Wright's classification of child behavior, children are classified as cooperative or possibly cooperative.
  • Children who are medically fit.
  • Children who are capable of interacting on a mental level.
  • Children between the ages of 6 to 8.
  • First dental visit.

Exclusion Criteria:

  • Children who struggle with behavioral control (uncooperative).
  • Children who have a history of allergic reaction to local anesthetic drugs.
  • Parental rejection for participation.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Local anesthesia injection with the comfort in jet (Needless system)
A needle-less injection approach will be used to administer the local anesthetic solution
Procedure: Local anesthesia injection
Local anesthesia administration
Active Comparator: Local anesthesia injection with needle injection (conventional technique).
A conventional aspirating syringe fitted with 27-gauge long needles will be used to administer the local anesthetic solution.
Procedure: Local anesthesia injection
Local anesthesia administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child behavior (Feeling pain during injection) (Binary Yes/No)
Time Frame: During injection (Immediate) (No follow up)
Pain perception during LA injection
During injection (Immediate) (No follow up)

Collaborators and Investigators

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

Sponsor

Cairo University

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)

September 20, 2022

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

May 20, 2023

Study Registration Dates

First Submitted

April 5, 2022

First Submitted That Met QC Criteria

April 12, 2022

First Posted (Actual)

April 19, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 9, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3399444

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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