Comparison of the Efficacy and Safety of Two Homologous Active Principles for Local Dental Anesthesia

NCT04166890 | Completed Phase 4

• 1 other identifier: Ensayo Clinico Articaina
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Drug Effect; Tooth Extraction

Keywords

Articaine; IANB; Third molar surgery; Non-inferiority; Local anesthesia

Outcome Measures

Primary Outcomes (3)

• Number of patients with total absence of sensitivity and pain

  Assessment of total absence of tactile and pain sensitivity after administration of the anesthetics.

  2 to 8 minutes

• Failure

  Assessment of the inability to block tactile sensitivity or painful sensitivity

  10 minutes

• Pain assessed by visual analogue pain scale

  Monitoring of the visual analogue pain (VAS) scale, where the amount of pain patient feels ranges from 0, non pain to 10, extreme amount of pain.

  One hour (1h)

Study Arms (4)

NS Lower right molar

EXPERIMENTAL

IANB Artheek SP Articaine EPINEPHrine Cartridge 4% 1:100000

Drug: Articaine / EPINEPHrine Cartridge

SD Lower Left molar

ACTIVE COMPARATOR

IANB Septanest Articaine EPINEPHrine Cartridge 4% 1:100000

Drug: Articaine / EPINEPHrine Cartridge

NS Lower left molar

EXPERIMENTAL

IANB Artheek SP Articaine EPINEPHrine Cartridge 4% 1:100000

Drug: Articaine / EPINEPHrine Cartridge

SD Lower right molar

ACTIVE COMPARATOR

IANB Septanest Articaine EPINEPHrine Cartridge 4% 1:100000

Drug: Articaine / EPINEPHrine Cartridge

Interventions

Articaine / EPINEPHrine Cartridge DRUG

The day scheduled for the surgery, vital signs (pulse, blood pressure and oxygen saturation) will be recorded prior the administration of the anesthesia. A volume of 1.8 ml of 4% articaine and epinephrine 1: 100000 solution of either the test product or the reference product will be deposited slowly to proceed to the inferior alveolar nerve block (IANB), according to the table of allocation of treatments in each period. The vital signs will continue to be monitored during the procedure, and once the procedure has been completed. If the volunteer needs more anesthetic, this will be recorded and will be administrated according to the maximum permitted doses (7 mg / kg (up to 500 mg) 5 mg / kg in children 7), and immediately after the administration, the vital signs will be taken again.

NS Lower left molar; NS Lower right molar; SD Lower Left molar; SD Lower right molar

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Antioquia: lead

Study Sites (1)

University of Antioquia

Medellín, Antioquia, Colombia

Location

Related Publications (18)

• Kim C, Hwang KG, Park CJ. Local anesthesia for mandibular third molar extraction. J Dent Anesth Pain Med. 2018 Oct;18(5):287-294. doi: 10.17245/jdapm.2018.18.5.287. Epub 2018 Oct 31.

  PMID: 30402548 BACKGROUND

• Castañeda DA, Briceño CR, Sánchez AE, Rodrí- guez A, Castro D, Barrientos S. Prevalencia de dientes incluidos, retenidos e impactados analizados en radiografías panorámicas de población de Bogotá, Colombia. Univ Odontol. 2015 Jul-Dic; 34(73): 149-157. http://dx.doi.org/10.11144/ Javeriana.uo34-73.

  BACKGROUND

• Organización Mundial de la Salud (OMS). Marco Conceptual de la Clasificación Internacional para la Seguridad del Paciente. Ginebra: OMS; 2009.

  BACKGROUND

• Becker DE, Reed KL. Essentials of local anesthetic pharmacology. Anesth Prog. 2006 Fall;53(3):98-108; quiz 109-10. doi: 10.2344/0003-3006(2006)53[98:EOLAP]2.0.CO;2.

  PMID: 17175824 BACKGROUND

• Aggarwal V, Singla M, Miglani S, Kohli S. Efficacy of Articaine Versus Lidocaine Administered as Supplementary Intraligamentary Injection after a Failed Inferior Alveolar Nerve Block: A Randomized Double-blind Study. J Endod. 2019 Jan;45(1):1-5. doi: 10.1016/j.joen.2018.09.012. Epub 2018 Dec 6.

  PMID: 30527595 BACKGROUND

• St George G, Morgan A, Meechan J, Moles DR, Needleman I, Ng YL, Petrie A. Injectable local anaesthetic agents for dental anaesthesia. Cochrane Database Syst Rev. 2018 Jul 10;7(7):CD006487. doi: 10.1002/14651858.CD006487.pub2.

  PMID: 29990391 BACKGROUND

• Mittal J, Kaur G, Mann HS, Narang S, Kamra M, Kapoor S, Sindhi M, Kataria R. Comparative Study of the Efficacy of 4% Articaine vs 2% Lidocaine in Surgical Removal of Bilaterally Impacted Mandibular Third Molars. J Contemp Dent Pract. 2018 Jun 1;19(6):743-748.

  PMID: 29959306 BACKGROUND

• Snoeck M. Articaine: a review of its use for local and regional anesthesia. Local Reg Anesth. 2012;5:23-33. doi: 10.2147/LRA.S16682. Epub 2012 Jun 5.

  PMID: 22915899 RESULT

• Bartlett G, Mansoor J. Articaine buccal infiltration vs lidocaine inferior dental block - a review of the literature. Br Dent J. 2016 Feb 12;220(3):117-20. doi: 10.1038/sj.bdj.2016.93.

  PMID: 26868800 RESULT

• Meechan JG. How to overcome failed local anaesthesia. Br Dent J. 1999 Jan 9;186(1):15-20. doi: 10.1038/sj.bdj.4800006.

  PMID: 10028738 RESULT

• Vree TB, Gielen MJ. Clinical pharmacology and the use of articaine for local and regional anaesthesia. Best Pract Res Clin Anaesthesiol. 2005 Jun;19(2):293-308. doi: 10.1016/j.bpa.2004.12.006.

  PMID: 15966499 RESULT

• Katyal V. The efficacy and safety of articaine versus lignocaine in dental treatments: a meta-analysis. J Dent. 2010 Apr;38(4):307-17. doi: 10.1016/j.jdent.2009.12.003. Epub 2009 Dec 16.

  PMID: 20006669 RESULT

• Malamed SF, Gagnon S, Leblanc D. Efficacy of articaine: a new amide local anesthetic. J Am Dent Assoc. 2000 May;131(5):635-42. doi: 10.14219/jada.archive.2000.0237.

  PMID: 10832257 RESULT

• Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.

  PMID: 21772732 RESULT

• Hersh EV, Giannakopoulos H, Levin LM, Secreto S, Moore PA, Peterson C, Hutcheson M, Bouhajib M, Mosenkis A, Townsend RR. The pharmacokinetics and cardiovascular effects of high-dose articaine with 1:100,000 and 1:200,000 epinephrine. J Am Dent Assoc. 2006 Nov;137(11):1562-71. doi: 10.14219/jada.archive.2006.0092.

  PMID: 17082283 RESULT

• Haas DA. An update on local anesthetics in dentistry. J Can Dent Assoc. 2002 Oct;68(9):546-51.

  PMID: 12366885 RESULT

• Haase A, Reader A, Nusstein J, Beck M, Drum M. Comparing anesthetic efficacy of articaine versus lidocaine as a supplemental buccal infiltration of the mandibular first molar after an inferior alveolar nerve block. J Am Dent Assoc. 2008 Sep;139(9):1228-35. doi: 10.14219/jada.archive.2008.0338.

  PMID: 18762633 RESULT

• Arboleda-Toro D, Toro L, Osorio-Osorno YA, Castrillon-Pino L, Florez-Zapata NMV. Comparing Articaine brands: A randomized non-inferiority controlled trial. Heliyon. 2021 Jun 9;7(6):e07252. doi: 10.1016/j.heliyon.2021.e07252. eCollection 2021 Jun.

  PMID: 34195402 DERIVED

MeSH Terms

Interventions

Carticaine

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fabian Jaimes, MD, PhD

  Universidad de Antioquia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Both anesthetics will be masked so that no differences are observed between them at the time of their application by the surgeon, clinical monitor and patient. Therefore, they will be covered with adhesive paper marked with the letter A or B. Each pair of anesthetics will be stored in an envelope and inside it will say the side that would apply each anesthetic (right or left) and each envelope will have a consecutive number from 1 to 196, and will be delivered to each patient in order of arrival at the study. Being a double blind study, it must be guaranteed that neither the patient, nor the surgeon, nor the clinical monitor knows about the allocation of treatments at the time of intervention.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Open, randomized, double blind, controlled, phase 4 crossover, randomized clinical trial will be conducted to compare the efficacy and clinical safety of two homologous active principles, articaine HCl with 1: 100,000 epinephrine (test) against the reference formulation 4% articaine HCl with 1: 100,000 of epinephrine, used intraorally in extraction of retained third molars (18), and will be carried out in the Faculty of Dentistry of the University of Antioquia

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: November 18, 2019
• Study Start: September 4, 2018
• Primary Completion: January 31, 2020
• Study Completion: March 30, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)