Anesthetic Efficacy of 1,8mL and 3,6mL of Articaine in Inferior Alveolar Nerve Block in Irreversible Pulpitis
Condition: Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

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.
    

Intervention name(s): Articaine; Articaine; Epinephrine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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; 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 intervention name(s): Articaine 100, DFL, Rio de Janeiro, RJ, Brasil; Articaine 100, DFL, Rio de Janeiro, RJ, Brasil
Intervention MeSH terms: Epinephrine; Carticaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anesthesia; volumes; articaine; Inferior alveolar nerve block