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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-25

Study Completion Date

2020-01-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Behaviour Assessment Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lidocaine 2% group

lidocaine hydrochloride 2% and epinephrine 1:100000 (Lignospan® standard, 1.7ml, SEPTODONT Ltd)

Group Type ACTIVE_COMPARATOR

lidocaine hydrochloride 2% and epinephrine 1:100000

Intervention Type DRUG

Local anesthetic agent

Articaine 4%

articaine hydrochloride 4% and epinephrine 1:100000 (Septocaine® 1.7ml, SEPTODONT Ltd)

Group Type EXPERIMENTAL

Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml

Intervention Type DRUG

Local anesthetic agent

Interventions

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Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml

Local anesthetic agent

Intervention Type DRUG

lidocaine hydrochloride 2% and epinephrine 1:100000

Local anesthetic agent

Intervention Type DRUG

Eligibility Criteria

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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.