search
Back to results

Anesthetic Efficacy of 1,8mL and 3,6mL of Articaine in Inferior Alveolar Nerve Block in Irreversible Pulpitis (Volumes)

Primary Purpose

Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Articaine
Articaine
Epinephrine
Sponsored by
Isabel Peixoto Tortamano
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulpitis focused on measuring anesthesia, volumes, articaine, Inferior alveolar nerve block

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients 18-50 years, with mandibular molars with irreversible pulpitis, and have 1 molar adjacent to a molar presenting irreversible pulpites and a healthy contralateral canine with no deep carious lesions, extensive restoration, advanced periodontal disease, a history of trauma, or sensitivity.

Exclusion Criteria:

  • Patients who took medication potentially interacting with the anesthetic used in the study

Sites / Locations

  • Faculdade de Odontologia da USP

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

injection of 1.8mL

injection of 3.6mL

Arm Description

injections of 1.8 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection

injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection

Outcomes

Primary Outcome Measures

Pain measured by a verbal analog scale

Secondary Outcome Measures

Presence of pulpal anesthesia by pulp electrical test
Patient's report for anesthesia on lip

Full Information

First Posted
March 27, 2015
Last Updated
June 15, 2016
Sponsor
Isabel Peixoto Tortamano
search

1. Study Identification

Unique Protocol Identification Number
NCT02422823
Brief Title
Anesthetic Efficacy of 1,8mL and 3,6mL of Articaine in Inferior Alveolar Nerve Block in Irreversible Pulpitis
Acronym
Volumes
Official Title
Comparative Evaluation of the Anesthetic Efficacy of 1,8mL and 3,6mL of 4% Articaine With 1: 100,000 Epinephrine in Blocking the Inferior Alveolar Nerve in Patients With Irreversible Pulpitis of Mandibular Molars
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Isabel Peixoto Tortamano

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Ninety patients with irreversible pulpitis diagnostic will participate in this clinical study. The participants will be divided into 2 groups of 45 patients, who will receive the inferior alveolar nerve block injections of 1.8 mL of 4% articaine (Articaine 100; DFL, Rio de Janeiro, RJ, Brazil) with 1:100,000 epinephrine or 3.6mL of the same solution. Two consecutive negative responses to the maximum pulp stimulus (80 µA) at the electric pulp test were the criterion to determine a pulpal anesthesia as successful. Ten minutes after the IAN block, subjective lip anesthesia will be evaluated by asking the patient whether his/her lip was numb. Thereafter and immediately before the pulpectomy, the electric pulp stimulations will be repeated to determine pulpal anesthesia. During the pulpectomy procedure, the patients were instructed to report any painful discomfort. To evaluate the intensity of pain during the pulpectomy, a verbal analogue scale will be used. The anesthesia will be defined as successful when the dentist accessed the pulp chamber without pain being reported by the patient. In these cases, the pulpectomy will be continued. If report pain will classified the IAN block as unsuccessful.
Detailed Description
Ninety patients will Participate in this clinical study. The patients will be admitted to the Emergency Center of the School of Dentistry at the University of São Paulo with a clinical diagnosis of irreversible pulpitis, The study was approved by the Committee on the Ethics of Research on Human Beings of the School of Dentistry at the University of São Paulo (protocol 95/07), and each patient will be informed to sing consent to participate in the study. The 90 participants will be divided into 2 groups of 45 patients, who will receive the inferior alveolar nerve block injections of 1.8 mL (equivalent to 1 cartridge) of 4% articaine (Articaine 100; DFL, Rio de Janeiro, RJ, Brazil) with 1:100,000 epinephrine or 3.6mL (equivalent to 2 cartridges) of the same solution. Two consecutive negative responses to the maximum pulp stimulus (80 µA) at the electric stimulation were the criterion to determine a pulpal anesthesia as successful. Before the IAN block injections, the tooth with irreversible pulpitis, the adjacent tooth, and the contralateral canine will be tested for pulp vitality with an electric pulp test (Vitality Scanner 2006; SybronEndo, Orange, CA). The electric pulp stimulation of the contralateral canine, which will be not anesthetized, will be used as control to ensure that the equipment is working properly and that patients is responding adequately. The average injection time for each cartridge was approximately 2 minutes. Ten minutes after the IAN block, subjective lip anesthesia will be evaluated by asking the patient whether his/her lip was numb. Thereafter and immediately before the pulpectomy, the electric pulp stimulations will be repeated to determine pulpal anesthesia. During the pulpectomy procedure, the patients were instructed to report any painful discomfort. To evaluate the intensity of pain during the pulpectomy, a verbal analogue scale will be used: 0, no pain; 1, mild, bearable pain; 2, moderate, unbearable pain; 3, severe, intense, and unbearable pain. The anesthesia will be defined as successful when the dentist accessed the pulp chamber without pain being reported by the patient (pain scores 0 or 1). In these cases, the pulpectomy will be continued. Pain scores of 2 or 3 will classified the IAN block as unsuccessful.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis
Keywords
anesthesia, volumes, articaine, Inferior alveolar nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
injection of 1.8mL
Arm Type
Experimental
Arm Description
injections of 1.8 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Arm Title
injection of 3.6mL
Arm Type
Experimental
Arm Description
injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Intervention Type
Drug
Intervention Name(s)
Articaine
Other Intervention Name(s)
Articaine 100, DFL, Rio de Janeiro, RJ, Brasil
Intervention Description
Injection of 1.8mL of 4% articaine with 1: 100,000 epinephrine in block the inferior alveolar nerve in patients with irreversible pulpitis of mandibular molar in 40 patients
Intervention Type
Drug
Intervention Name(s)
Articaine
Other Intervention Name(s)
Articaine 100, DFL, Rio de Janeiro, RJ, Brasil
Intervention Description
Injection of 3.6mL of 4% articaine with 1: 100,000 epinephrine in block the inferior alveolar nerve in patients with irreversible pulpitis of mandibular molar in 40 patients
Intervention Type
Drug
Intervention Name(s)
Epinephrine
Primary Outcome Measure Information:
Title
Pain measured by a verbal analog scale
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
Presence of pulpal anesthesia by pulp electrical test
Time Frame
10 minutes after the block
Title
Patient's report for anesthesia on lip
Time Frame
10 minutes after the block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients 18-50 years, with mandibular molars with irreversible pulpitis, and have 1 molar adjacent to a molar presenting irreversible pulpites and a healthy contralateral canine with no deep carious lesions, extensive restoration, advanced periodontal disease, a history of trauma, or sensitivity. Exclusion Criteria: Patients who took medication potentially interacting with the anesthetic used in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabel P Tortamano
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculdade de Odontologia da USP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05508-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31365529
Citation
Silva SA, Horliana ACRT, Pannuti CM, Braz-Silva PH, Bispo CGC, Buscariolo IA, Rocha RG, Tortamano IP. Comparative evaluation of anesthetic efficacy of 1.8 mL and 3.6 mL of articaine in irreversible pulpitis of the mandibular molar: A randomized clinical trial. PLoS One. 2019 Jul 31;14(7):e0219536. doi: 10.1371/journal.pone.0219536. eCollection 2019.
Results Reference
derived

Learn more about this trial

Anesthetic Efficacy of 1,8mL and 3,6mL of Articaine in Inferior Alveolar Nerve Block in Irreversible Pulpitis

We'll reach out to this number within 24 hrs