Articaine Efficacy and Safety for Children Below Age of 4-years

February 12, 2020 updated by: Ahmad Elheeny, Minia University

Articaine Efficacy and Safety in Young Children Below Age of Four Years: An Equivalent Parallel Randomized Control Trial

Pain control is one of the significant behavior determinants in the dental office and shaping the future attitude toward dentistry, especially in children. One of widely used local anesthetic agents is articaine hydrochloride because of its superior potency, over traditionally used 2% lidocaine. Therefore, this study intends to get the benefits of articaine efficiency and apply it in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 2
  • Phase 1

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
    • Minia
      • Minya, Minia, Egypt, 61111
        • Ngwa Khattab

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

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged 36-47 months. ASA I, II. Mentally capable of communication. Having a mandibular primary molar tooth that required extraction or pulpotomy.

Exclusion Criteria:

  • The presence of infection, which may compromise the efficiency of local anesthetic agent Significant behaviour problems Medical or mental unfitness

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
Active Comparator: Lidocaine 2% group
lidocaine hydrochloride 2% and epinephrine 1:100000 (Lignospan® standard, 1.7ml, SEPTODONT Ltd)
Drug: lidocaine hydrochloride 2% and epinephrine 1:100000
Local anesthetic agent
Experimental: Articaine 4%
articaine hydrochloride 4% and epinephrine 1:100000 (Septocaine® 1.7ml, SEPTODONT Ltd)
Drug: Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml
Local anesthetic agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain assessment
Time Frame: During the procedures
FLACC scale
During the procedures
Behavior
Time Frame: before and after the procedures
Frankl behaviour scale
before and after the procedures

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative complications
Time Frame: 24 hours after the procedures
Asking parents/caregiver in the next 24 hours using Parents' postoperative pain measure (PPPM)
24 hours after the procedures

Collaborators and Investigators

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

Sponsor

Minia University

Investigators

  • Principal Investigator: Ahmad Elheeny, 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)

August 25, 2019

Primary Completion (Actual)

January 15, 2020

Study Completion (Actual)

January 15, 2020

Study Registration Dates

First Submitted

August 15, 2019

First Submitted That Met QC Criteria

August 16, 2019

First Posted (Actual)

August 19, 2019

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 12, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 245

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

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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