Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits

NCT01912755 | Completed Phase 4

• 1 other identifier: 2009-10834-4
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study was to verify the effectiveness of an anesthetic called articaine for dental treatment, comparing it with an anesthetic commonly used in dental clinic: lidocaine. Two types of local anesthesia (oral injection) in accordance with the solution used were performed. For patients anesthetized with articaine, an injection of anesthesia close to the tooth to be treated was used. For the anesthetic lidocaine an injection on the cheek at the bottom of the mouth was made. Differences between both techniques are mainly regarding the area of numbness. In the injection with articaine only a small part of the lip and the tooth was anesthetized. With lidocaine injection, the lower region of the entire side of the tooth and half of the tongue on the same side was numbed. The treatment was electronic randomized and there was equal chance to one or another treatment. The investigators are studying this new form of anesthesia (near the tooth that was treated) to see if it can numb the tooth to an emergency treatment, if it really decreases the feeling of numbness and discomfort during the service. Patients receiving articaine were submitted to cone beam exam at no cost.

Conditions

Irreversible Pulpitis; Pain

Keywords

Pulpitis; Hot tooth; Articaine; Lidocaine; Local anesthetics

Outcome Measures

Primary Outcomes (1)

• Pain perception 3

  Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.

  10 minutes after injection

Secondary Outcomes (4)

• Buccal cortical bone thickness

  one week after injection

• Root distance to the bone

  one week after injection

• Basal pain perception

  10 minutes before injection

• Pain perception 2

  5 minutes before injection

Study Arms (2)

Articaine

EXPERIMENTAL

injection of 1.8 mL buccal infiltrations of 4% articaine with 1:100,000 epinephrine in one tooth with a clinical diagnosis of symptomatic irreversible pulpitis.

Drug: 4% articaine with 1:100,000 epinephrine; Drug: 2% lidocaine with 1:100,000 epinephrine

Lidocaine

ACTIVE COMPARATOR

1.8 mL 2% lidocaine with 1:100,000 epinephrine injected as inferior alveolar nerve block in the mandible side with one tooth with a clinical diagnosis of symptomatic irreversible pulpitis.

Drug: 4% articaine with 1:100,000 epinephrine; Drug: 2% lidocaine with 1:100,000 epinephrine

Interventions

4% articaine with 1:100,000 epinephrine DRUG

If the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine.

Also known as: articaine

Articaine; Lidocaine

2% lidocaine with 1:100,000 epinephrine DRUG

If the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine.

Also known as: Lidocaine

Articaine; Lidocaine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• long-lasting moderate to severe pain during cold test
• absence of periapical radiolucency except for a widened periodontal ligament (evaluated in periapical radiographs)
• vital coronal pulp on access opening

You may not qualify if:

• Previous history of allergy to local anesthetics
• Subjects with systemic diseases
• Pregnancy and lactation
• Subjects taking any kind of medication that could change or influence the outcome of this research
• Subjects without painful symptoms
• Negative thermal testing, periapical lesion, incomplete root formation, presence of fistula or abscess, cracks or fractures

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Piracicaba Dental School - UNICAMP

Piracicaba, São Paulo, 13414-903, Brazil

Location

Related Publications (4)

• Aggarwal V, Jain A, Kabi D. Anesthetic efficacy of supplemental buccal and lingual infiltrations of articaine and lidocaine after an inferior alveolar nerve block in patients with irreversible pulpitis. J Endod. 2009 Jul;35(7):925-9. doi: 10.1016/j.joen.2009.04.012.

  PMID: 19567309 BACKGROUND

• Ashraf H, Kazem M, Dianat O, Noghrehkar F. Efficacy of articaine versus lidocaine in block and infiltration anesthesia administered in teeth with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2013 Jan;39(1):6-10. doi: 10.1016/j.joen.2012.10.012. Epub 2012 Nov 13.

  PMID: 23228249 BACKGROUND

• Berlin J, Nusstein J, Reader A, Beck M, Weaver J. Efficacy of articaine and lidocaine in a primary intraligamentary injection administered with a computer-controlled local anesthetic delivery system. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 Mar;99(3):361-6. doi: 10.1016/j.tripleo.2004.11.009.

  PMID: 15716846 BACKGROUND

• Monteiro MR, Groppo FC, Haiter-Neto F, Volpato MC, Almeida JF. 4% articaine buccal infiltration versus 2% lidocaine inferior alveolar nerve block for emergency root canal treatment in mandibular molars with irreversible pulpits: a randomized clinical study. Int Endod J. 2015 Feb;48(2):145-52. doi: 10.1111/iej.12293. Epub 2014 May 22.

  PMID: 24702239 DERIVED

MeSH Terms

Conditions

Pain; Pulpitis

Interventions

Carticaine; Epinephrine; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• José FA Almeida, DDS, PhD

  Endodontics Area - FOP-UNICAMP

  STUDY CHAIR

• Maria RF Monteiro, DDS, MSc

  Endodontics Area - FOP-UNICAMP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physiological Sciences Department

Study Record Dates

• First Submitted: July 19, 2013
• First Posted: July 31, 2013
• Study Start: February 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

BR (1)