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

June 15, 2016 updated by: Isabel Peixoto Tortamano

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05508-000
        • Faculdade de Odontologia da USP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: injection of 1.8mL
injections of 1.8 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Drug: Epinephrine
Drug: Articaine
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
Other Names:
  • Articaine 100, DFL, Rio de Janeiro, RJ, Brasil
Drug: Articaine
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
Other Names:
  • Articaine 100, DFL, Rio de Janeiro, RJ, Brasil
Experimental: injection of 3.6mL
injections of 3.6 mL of 4% articaine with 1:100,000 epinephrine Intervention: inferior alveolar nerve block injection
Drug: Epinephrine
Drug: Articaine
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
Other Names:
  • Articaine 100, DFL, Rio de Janeiro, RJ, Brasil
Drug: Articaine
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
Other Names:
  • Articaine 100, DFL, Rio de Janeiro, RJ, Brasil

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Pain measured by a verbal analog scale
Time Frame: intraoperative
intraoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Presence of pulpal anesthesia by pulp electrical test
Time Frame: 10 minutes after the block
10 minutes after the block
Patient's report for anesthesia on lip
Time Frame: 10 minutes after the block
10 minutes after the block

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Isabel Peixoto Tortamano

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Isabel P Tortamano, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Volumes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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