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Completed

NCT Number: NCT04477317

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

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.

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Key information

Conditions

Local Anesthesia

Age range

5 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of dentistry cairo university

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

4% Articaine Hydrochloride with 1:100,000 Adrenaline

Drug

new Egyptian articane anesthetic solution.

Other names: %4 Alexadricaine

2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin

Drug

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.

Other names: 2% Mepicaine-L

Primary outcomes

  1. Intra-operative pain during extraction

    Time frame: through study completion, an average of 1 year

    measured by Visual Analogue Scale (VAS) and Sound Eye Motor (SEM) scale

Secondary outcomes

  1. onset of anesthesia

    Time frame: through study completion, an average of 1 year

    measured in minutes using stopwatch

  2. duration of anesthesia

    Time frame: through study completion, an average of 1 year

    measured in minutes using stopwatch

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jul 20, 2020
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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