Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L in Children

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

PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-01

Study Completion Date

2021-10-30

Brief Summary

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The aim of the present study is to evaluate and compare the anesthetic efficacy of Alexadricaine versus Mepecaine-L infiltration anesthesia in children during extraction of badly decayed or unrestorable maxillary first primary molars.

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Detailed Description

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To our knowledge, no clinical trials in literature have been done to compare anesthetic efficacy of 4% Articaine versus 2% Mepivacaine in pain management during extraction of badly decayed upper first primary molars. Thus, the purpose of the present study was to fill this knowledge gap.

This trial will be held on a new brand of 4% articaine made in Egypt called Alexadricaine anesthetic solution where no clinical trials have been conducted on it yet in literature.

Conditions

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Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental

4% Articaine Hydrochloride with 1:100,000 Adrenaline (Alexadricaine, Alexandria Co., Egypt).

Group Type EXPERIMENTAL

4% Articaine Hydrochloride with 1:100,000 Adrenaline

Intervention Type DRUG

new Egyptian articane anesthetic solution.

Control

2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin (Mepicaine-L, Alexandria Co., Egypt)

Group Type ACTIVE_COMPARATOR

2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin

Intervention Type DRUG

Mepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost.

Interventions

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4% Articaine Hydrochloride with 1:100,000 Adrenaline

new Egyptian articane anesthetic solution.

Intervention Type DRUG

2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin

Mepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost.

Intervention Type DRUG

Other Intervention Names

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%4 Alexadricaine 2% Mepicaine-L

Eligibility Criteria

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Inclusion Criteria

* Medically fit (ASA I, II).
* Mentally capable of communication.
* Children aged 5-7 years, children older than 8 years old will not be included due to physiologic root resorption associated with shedding which may simplify the extraction procedure(25).
* First maxillary primary molar needs extraction due to root caries "beyond possible repair".
* First dental visit.
* Child must give assent prior to participation, as well as approved parental informed written consent.

Exclusion Criteria

* Children with acute or sub-acute dento-alveolar abscess Children with history of prolonged bleeding, platelet disorders, Hyperthyroidism or hypersensitivity.
* Patients who had taken analgesics or antibiotics in the 12-hrs preceding the injection.

Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes