Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia
Status:
Completed
Trial end date:
2020-03-30
Target enrollment:
Participant gender:
Summary
In the complexity of the Dental care the third molar surgery is one of the most common
procedures, it is indicated for multiple reasons like infections in root canal, prosthetics
or even esthetical purposes. This surgery can be safely performed with the help of local
anesthetics, due to their quick action, and reversibility to control pain, reducing possible
complications during and after the surgeries.
Among the different types of local anesthetics used in dentistry, the articaine bears
characteristics that provide some advantages compared to similar anesthetics like Lidocaine,
being one of the most used anesthetics worldwide. Different authors have concluded that it is
a safe when used in patients at different ages and it is effective as a local anesthetic in
the majority of procedures. It is important for dentists to know the differences or
similarities of anesthetics in terms of their effects, safety, dosages required in patients
undergoing surgical removal of teeth, as well as the mechanism of action and pharmacological
properties, in order to take advantage of its benefits and minimize risks.
This study aims to test the efficacy and safety of an anesthetic solution, based on the same
active molecule, articaine, manufactured by two different commercial houses, one domestic and
one international, in order to gather scientific evidence and to show that they are not
different. This will provide scientific results to help in the selection of any of these
brands to be used with confidence in the dental practice. This will strengthen the
collaboration between the academy and the companies, which would allow them to improve the
quality of their products.
Locally there are no studies available comparing the articaine-type anesthetic with
epinephrine at the same concentration, manufactured locally by a national company, to a
foreign one, which is an important opportunity to expand the knowledge and create scientific
reports, about what a local anesthetic is and what it does.
Finally, this study would contribute to the need to guarantee the quality of medicines in
Colombia, by means of compliance with the legal provisions contemplated in resolution 1890 of
November 2001 and 1400 of August 2001, issued by the Ministry of Health of Colombia :
"Requirements to demonstrate the therapeutic effectiveness, through studies of
Bioavailability and Bioequivalence of medicines for a special group of them.