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

NCT ID: NCT01912755

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-01-31

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.

Detailed Description

Aim: This randomized clinical trial compared the anesthetic efficacy of buccal infiltration (BI) with 4% articaine (AR) and inferior alveolar nerve block (IANB) with 2% lidocaine (LI), both with 1:100,000 epinephrine, in symptomatic mandibular molars with irreversible pulpitis. Likewise, we compared the efficacy of the primary infiltration (BI or IANB) with one supplemental injection (intraligamentary infiltration with articaine for AR and BI with articaine for LI). The influences of buccal cortical bone thickness and root distances to buccal cortical bone on articaine performance (AR) were also evaluated using cone-beam tomography. methodology: Volunteers presenting symptomatic mandibular molars with irreversible pulpitis were randomly divided into two groups (30 for AR and 20 for LI). Success was recorded when complete pain-free treatment was achieved after primary injection or when one supplemental injection was needed for emergency endodontic procedures.

Conditions

Irreversible Pulpitis; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Articaine

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.

Group Type: EXPERIMENTAL

4% articaine with 1:100,000 epinephrine

Intervention Type: 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.

2% lidocaine with 1:100,000 epinephrine

Intervention Type: 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.

Lidocaine

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.

Group Type: ACTIVE_COMPARATOR

4% articaine with 1:100,000 epinephrine

Intervention Type: 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.

2% lidocaine with 1:100,000 epinephrine

Intervention Type: 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.

Interventions

4% articaine with 1:100,000 epinephrine

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.

Intervention Type: DRUG

2% lidocaine with 1:100,000 epinephrine

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.

Intervention Type: DRUG

Other Intervention Names

articaine; Lidocaine

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

University of Campinas, Brazil

OTHER

Sponsor Role: lead

Responsible Party

Francisco Groppo

Professor of Physiological Sciences Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José FA Almeida, DDS, PhD

Role: STUDY_CHAIR

Endodontics Area - FOP-UNICAMP

Maria RF Monteiro, DDS, MSc

Role: PRINCIPAL_INVESTIGATOR

Endodontics Area - FOP-UNICAMP

Locations

Piracicaba Dental School - UNICAMP

Piracicaba, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: BACKGROUND

PMID: 19567309 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23228249 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15716846 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24702239 (View on PubMed)

Other Identifiers

2009-10834-4

Identifier Type: -

Identifier Source: org_study_id