Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block

NCT02440347 | Completed Phase 4

• 2 other identifiers: 36/5-2015175021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Local Anesthesia

Keywords

local anesthesia; articaine; AMSA

Outcome Measures

Primary Outcomes (1)

• Duration of pulpal anesthesia

  Duration of pulpal maxillary anesthesia of all maxillary teeth in anesthetized side of upper jaw assessed by electrical pulp testing at 2-minute intervals.

  up to 64 minutes from baseline

Secondary Outcomes (23)

• Onset of pulpal anesthesia

  Up to 8 minutes

• Width of anesthetic field marginal-superior

  5 minutes

• Width of anesthetic field medial-lateral

  5 minutes

• Duration of soft tissue anesthesia buccal

  Up to 120 min

• Duration of soft tissue anesthesia palatal

  Up to 120 minutes

Study Arms (2)

Computer controlled anesthetic delivery by Anaeject

EXPERIMENTAL

Patients received single dose of 0.6 ml of 4% articaine with epinephrine (1:100.000) by computer controlled anesthetic delivery system (C-CLADS) for AMSA nerve block

Device: Computer controlled anesthetic delivery by Anaeject

Conventional anesthetic delivery by carpule syringe

ACTIVE COMPARATOR

Patients received single dose of 0.6 ml of 4% articaine with epinephrine (1:100.000) by conventional anesthetic delivery for AMSA nerve block

Device: Conventional anesthetic delivery by carpule syringe

Interventions

Computer controlled anesthetic delivery by Anaeject DEVICE

Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject).

Computer controlled anesthetic delivery by Anaeject

Conventional anesthetic delivery by carpule syringe DEVICE

Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).

Conventional anesthetic delivery by carpule syringe

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I
• full maxillary dental arch
• vital maxillary teeth without caries, restorations, periodontal disease or history of trauma

You may not qualify if:

• allergies to local anesthetic solution ingredients, food and drugs
• alcohol and drugs abuse
• heavy tobacco smoking

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

School of Dental Medicine, University of Belgrade

Belgrade, 11000, Serbia

Location

Study Officials

• Bozidar M Brkovic, DDS, PhD

  School of Dental Medicine, University of Belgrade

  PRINCIPAL INVESTIGATOR

• Dejan Cetkovic, DDS

  School of Dental Medicine, University of Belgrade

  PRINCIPAL INVESTIGATOR

• Vladimir M Biocanin, DDS, PhD

  Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina

  PRINCIPAL INVESTIGATOR

• Marija S Milic, DDS

  School of Dental Medicine, University of Belgrade

  PRINCIPAL INVESTIGATOR

• Ivana Brajic, DDS

  School of Dental Medicine, University of Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS PhD Professor

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 12, 2015
• Study Start: June 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 24, 2015

Record last verified: 2015-07

Locations

SE (1)