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: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Universidad de Antioquia
• Treatments: Anesthetics; Carticaine; Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

• Healthy men and women, criteria assessed during anamnesis

• Age between 18 and 25 years old

• Presence of lower third molars in the mouth with no level of eruption determined by the clinical oral examination

• Weight / height ratio with a coefficient of variation of no more than 15% of the ideal weight, according to the tables of the Metropolitan Life Insurance

• Lower third molars in a mesio-angulated position evidenced by the panoramic radiography taken for the study in the Faculty of Dentistry of the University of Antioquia, and which is in Nolla's stage equal or greater than 6

• Voluntary acceptance to participate in the study by signing the informed consent

Exclusion Criteria:

• Presence of phobias or traumas related to the dental practice and/or with needles

• Presence of clinical problems such as kidney diseases, cardiovascular diseases, known allergies or drug hypersensitivity discovered through the anamnesis of the clinical history prepared for the investigation

• Hi consumption of alcohol or cigarettes

• Presence of problems related to drug dependence

• Being ill for the last two weeks before the study begins

• use of enzyme inhibitors or inducers for four weeks prior to the participation in the study

• Have used any medication or natural product, seven days prior to the first part of the study

• Have donated blood in the last three months

• Have participated in another clinical trial, thirty days prior to the first part of the study

• Be a member of the research group or a relative of the responsible personnel involved in the study.