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

Local Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04477317
• Other study ID #: local anesthesia in chilldren
• Status: Completed
• Phase: Phase 3
• Start date: August 1, 2021
• Est. completion date: October 30, 2021

Study information

• Verified date: March 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

Drug:
• 4% Articaine Hydrochloride with 1:100,000 Adrenaline
new Egyptian articane anesthetic solution.
• 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.

Locations

Country	Name	City	State
Egypt	Faculty of dentistry cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	onset of anesthesia	measured in minutes using stopwatch	through study completion, an average of 1 year
Secondary	duration of anesthesia	measured in minutes using stopwatch	through study completion, an average of 1 year