Local Anesthesia
Conditions
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.
Interventions
DRUG4% Articaine Hydrochloride with 1:100,000 Adrenaline
new Egyptian articane anesthetic solution.
DRUG2% 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 7 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed