Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block
Condition: Local Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to investigate and compare pulpal anesthesia and cardiovascular
      parameters obtained with 0.6 ml of 4% articaine with epinephrine (1:100.000) for anterior and
      middle superior alveolar nerve (AMSA) block performed by standard and computer-controlled
      delivery in healthy volunteers.
    

Detailed description: 
      Traditionally, pulpal anesthesia is obtained by infiltration or mandibular nerve block.
      However, it is not always possible to achieve complete pulpal anesthesia with previously
      mentioned anesthetic techniques.

      It is well documented that administration of 0,6-0,9 ml of anesthetic solution with palatal
      approach with anterior middle superior injection (AMSA) provided successful pulpal anesthesia
      from central incisor to second premolar. In addition, palatal soft tissues from midpalate to
      free gingiva and from central incisor to first molar are fully anesthetized with AMSA. The
      injection site is located at a point that bisects the maxillary first and second premolars,
      and midway between the crest of the free gingival margin and mid-palatine suture. The needle
      is orientated at a 45-degree angle with the bevel facing the palatal tissue. AMSA presents
      intraosseous anesthetic technique.

      Traditionally, palatal injection administered with conventional syringe was described as very
      painful. On the other hand, computer controlled local anesthetic delivery system (CCLADS) has
      been recommended for AMSA as a system which allows slow administration of anesthetic
      solution, with constant pressure. It was shown that AMSA do not provide undesired buccal and
      upper lip anesthesia.

      The AMSA technique has been recommended for proce¬dures ranging from operative restorations,
      crown preparation to scaling and root planning.

      The aim of this study is to evaluate and compare parameters of pulpal anesthesia and
      cardiovascular function after AMSA injection of 4% articaine with epinephrine (1:100.000),
      delivered by conventional syringe or CCLADS. Study sample will comprise 30 healthy (ASA1)
      volunteers who will receive 0.6 ml 4% articaine with epinephrine (1:100.000) by conventional
      syringe, and after two-week washout period the same amount of local anesthetic by CCLADS.
      Parameters of pulpal and soft tissue anesthesia (onset and duration) for all maxillary teeth
      on the anesthetized side, as well as parameters of cardiovascular function (systolic blood
      pressure, diastolic blood pressure, heart rate) will be monitored and compared.
    

Intervention name(s): Computer controlled anesthetic delivery by Anaeject; Conventional anesthetic delivery by carpule syringe
Intervention type(s): Device; Device
Intervention description(s): Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject).; Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: local anesthesia; articaine; AMSA