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

NCT02422823 | Completed

• 1 other identifier: Volumes
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulpitis

Keywords

anesthesia; volumes; articaine; Inferior alveolar nerve block

Outcome Measures

Primary Outcomes (1)

• Pain measured by a verbal analog scale

  intraoperative

Secondary Outcomes (2)

• Presence of pulpal anesthesia by pulp electrical test

  10 minutes after the block

• Patient's report for anesthesia on lip

  10 minutes after the block

Study Arms (2)

injection of 1.8mL

EXPERIMENTAL

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

Drug: Articaine; Drug: Epinephrine

injection of 3.6mL

EXPERIMENTAL

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

Drug: Articaine; Drug: Epinephrine

Interventions

Articaine DRUG

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

Also known as: Articaine 100, DFL, Rio de Janeiro, RJ, Brasil

injection of 1.8mL

Epinephrine DRUG

injection of 1.8mL; injection of 3.6mL

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Isabel Peixoto Tortamano: lead

Study Sites (1)

Faculdade de Odontologia da USP

São Paulo, São Paulo, 05508-000, Brazil

Location

Related Publications (1)

• 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.

  PMID: 31365529 DERIVED

MeSH Terms

Conditions

Pulpitis

Interventions

Carticaine; Epinephrine

Condition Hierarchy (Ancestors)

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

Study Officials

• Isabel P Tortamano

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 21, 2015
• Study Start: April 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 16, 2016

Record last verified: 2016-05

Locations

BR (1)