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

Cairo University (CU) logo

Cairo University (CU)

Status and phase

Completed
Phase 3

Conditions

Local Anesthesia

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04477317
local anesthesia in chilldren

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

5 to 7 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

10 participants in 2 patient groups

Experimental
Experimental group
Description:
4% Articaine Hydrochloride with 1:100,000 Adrenaline (Alexadricaine, Alexandria Co., Egypt).
Treatment:
Drug: 4% Articaine Hydrochloride with 1:100,000 Adrenaline
Control
Active Comparator group
Description:
2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin (Mepicaine-L, Alexandria Co., Egypt)
Treatment:
Drug: 2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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