Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years

Articaine 4% Efficacy and Safety in Extraction and Pulpotomy of Primary Molars of Children Below the Age of Four Years.

compare the anaesthetic efficacy and safety for pain and behaviour for extraction or pulp therapy in primary molars in young children below four years old using 4% articaine and 2% lidocaine local anesthetics.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Behavior
• Intervention / Treatment: Drug: Lidocain hydrochloride 2 % with epinephrine; Drug: Articaine chloride 4% with epinephrine

• Study Type: Interventional
• Enrollment (Anticipated): 292
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy children
• 3-6 years
• primary molar indicated for pulpotomy
• body weight not less than 15 Kg

Exclusion Criteria:

• Intellectual problem
• sever emotional problems
• previous dental experience
• Medically or mentally compromised children

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lidocaine; Lidocain hydrochloride 2 %with epinephrine 1:100000	Drug: Lidocain hydrochloride 2 % with epinephrine; Local anesthesia infilteration in children
Experimental: Articaine; Articaine chloride 4% with epinephrine 1:100000	Drug: Articaine chloride 4% with epinephrine; Articaine chloride 4% with epinephrine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra and post operative pain	Evaluate pain during injection and treatment using FLACC (face,legs,activity, cry, consolabolity) scale	30-60 minutes
Behavior	Evaluate child behavior using frankl scale during treatment	30-60 minutes
Blood pressure	Vital signs	30-60 minutes
Heart rate	Vital signs	30-60 minutes
Respiratory rate measuring during treatment	Vital signs	30-60 minutes

Collaborators and Investigators

• Sponsor: Mahmoud Ahmed Mahmoud

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: October 28, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2021
• Last Update Submitted That Met QC Criteria: October 29, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Lidocaine; Epinephrine; Racepinephrine; Epinephryl borate; Carticaine
• Other Study ID Numbers: 3081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No