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

Study Overview
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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.

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.

Official Title
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Anesthetic Efficacy of %4Alexadricaine Versus %2 Mepicaine-L for Infiltration Anesthesia in Extraction of Maxillary First Primary Molars in Children

Conditions
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Local Anesthesia

Intervention / Treatment
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* Drug: 4% Articaine Hydrochloride with 1:100,000 Adrenaline
* Drug: 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>4% Articaine Hydrochloride with 1:100,000 Adrenaline (Alexadricaine, Alexandria Co., Egypt). | Drug: 4% Articaine Hydrochloride with 1:100,000 Adrenaline<br>* new Egyptian articane anesthetic solution.<br>* Other names: %4 Alexadricaine;|
| Active Comparator: Control<br>2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin (Mepicaine-L, Alexandria Co., Egypt) | Drug: 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin<br>* 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.<br>* Other names: 2% Mepicaine-L;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra-operative pain during extraction | measured by Visual Analogue Scale (VAS) and Sound Eye Motor (SEM) scale | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| onset of anesthesia | measured in minutes using stopwatch | through study completion, an average of 1 year | 
| duration of anesthesia | measured in minutes using stopwatch | through study completion, an average of 1 year |