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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 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 scal
Sponsor: Isabel Peixoto Tortamano

Current Primary Outcome: Pain measured by a verbal analog scale [ Time Frame: intraoperative ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Presence of pulpal anesthesia by pulp electrical test [ Time Frame: 10 minutes after the block ]
  • Patient's report for anesthesia on lip [ Time Frame: 10 minutes after the block ]


Original Secondary Outcome: Same as current

Information By: University of Sao Paulo

Dates:
Date Received: March 27, 2015
Date Started: April 2015
Date Completion:
Last Updated: June 15, 2016
Last Verified: May 2016