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

Phase 3

Completed

• Conditions: Local Anesthesia

• Registration Number: NCT04477317
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Study Start: 2021-08-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-10-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-11
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
onset of anesthesia	through study completion, an average of 1 year	measured in minutes using stopwatch
duration of anesthesia	through study completion, an average of 1 year	measured in minutes using stopwatch

Trial Locations

Locations (1)

Faculty of dentistry cairo university; 🇪🇬 Cairo, Egypt