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

Primary Purpose

Irreversible Pulpitis, Pain

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
4% articaine with 1:100,000 epinephrine
2% lidocaine with 1:100,000 epinephrine
Sponsored by
University of Campinas, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irreversible Pulpitis focused on measuring Pulpitis, Hot tooth, Articaine, Lidocaine, Local anesthetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Piracicaba Dental School - UNICAMP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Articaine

Lidocaine

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain perception 3
Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.

Secondary Outcome Measures

Buccal cortical bone thickness
Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the buccal cortical bone thickness.
Root distance to the bone
Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the the distance between the mesial and lingual roots to the buccal cortical bone.
Basal pain perception
Patients received visual analogue scales (VAS) to record their pain perception 10 min before the local anesthetic injection.
Pain perception 2
Patients received visual analogue scales (VAS) to record their pain perception 5 min before the local anesthetic injection (after the cold testing).

Full Information

First Posted
July 19, 2013
Last Updated
July 29, 2013
Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01912755
Brief Title
Anesthetic Efficacy of Articaine and Lidocaine in Lower Molars With Irreversible Pulpits
Official Title
Anesthetic Efficacy of 4% Articaine (Mandibular Infiltration) and 2% Lidocaine (Alveolar Nerve Block), Associated With 1:100.000 Epinephrine, in Lower Molars With Irreversible Pulpits
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Campinas, Brazil
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irreversible Pulpitis, Pain
Keywords
Pulpitis, Hot tooth, Articaine, Lidocaine, Local anesthetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Articaine
Arm Type
Experimental
Arm Description
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.
Arm Title
Lidocaine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
4% articaine with 1:100,000 epinephrine
Other Intervention Name(s)
articaine
Intervention Description
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
Intervention Name(s)
2% lidocaine with 1:100,000 epinephrine
Other Intervention Name(s)
Lidocaine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain perception 3
Description
Patients received visual analogue scales (VAS) to record their pain perception ten minutes after local anesthetic injection.
Time Frame
10 minutes after injection
Secondary Outcome Measure Information:
Title
Buccal cortical bone thickness
Description
Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the buccal cortical bone thickness.
Time Frame
one week after injection
Title
Root distance to the bone
Description
Cone-beam computed tomography scans (iCat, Imaging Science, USA) were taken from patients submitted to articaine injection in order to measure the the distance between the mesial and lingual roots to the buccal cortical bone.
Time Frame
one week after injection
Title
Basal pain perception
Description
Patients received visual analogue scales (VAS) to record their pain perception 10 min before the local anesthetic injection.
Time Frame
10 minutes before injection
Title
Pain perception 2
Description
Patients received visual analogue scales (VAS) to record their pain perception 5 min before the local anesthetic injection (after the cold testing).
Time Frame
5 minutes before injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José FA Almeida, DDS, PhD
Organizational Affiliation
Endodontics Area - FOP-UNICAMP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maria RF Monteiro, DDS, MSc
Organizational Affiliation
Endodontics Area - FOP-UNICAMP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piracicaba Dental School - UNICAMP
City
Piracicaba
State/Province
SP
ZIP/Postal Code
13414-903
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19567309
Citation
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.
Results Reference
background
PubMed Identifier
23228249
Citation
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.
Results Reference
background
PubMed Identifier
15716846
Citation
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.
Results Reference
background
PubMed Identifier
24702239
Citation
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.
Results Reference
derived

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

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