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Clinical trial

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

ID
Name
local anesthesia in chilldren
Description
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.
Trial arms
Trial start
2021-08-01
Estimated PCD
2021-09-30
Trial end
2021-10-30
Status
Completed
Phase
Early phase I
Treatment
4% Articaine Hydrochloride with 1:100,000 Adrenaline
new Egyptian articane anesthetic solution.
Arms:
Experimental
Other names:
%4 Alexadricaine
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.
Arms:
Control
Other names:
2% Mepicaine-L
Size
10
Primary endpoint
Intra-operative pain during extraction
through study completion, an average of 1 year
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 10, 'type': 'ACTUAL'}}
Updated at
2023-03-14

1 organization

2 products

1 indication

Organization
Cairo University
Product
Articaine Hydrochloride
Indication
Local Anesthesia
Product
Mepivacaine