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

Efficacy of Anterior and Middle Superior Alveolar (AMSA) Nerve Block Anesthesia Obtained by Articaine Computer-controlled and Conventional Delivery

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 for maxillary teeth extraction.

Study Overview

• Status: Withdrawn
• Conditions: Local Anesthesia
• Intervention / Treatment: Drug: Computer controlled 4% articaine delivery by Anaeject; Drug: Conventional 4% articaine delivery by carpule syringe

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • School of dental medicine, University of Belgrade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA 1
• maxillary incisors canines or premolars indicated for extraction due to periapical pathology, root fracture or orthodontic treatment

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Computer controlled 4% articaine delivery by Anaeject	Drug: Computer controlled 4% articaine delivery by Anaeject; Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject)
Active Comparator: Conventional 4% articaine delivery by carpule syringe	Drug: Conventional 4% articaine delivery by carpule syringe; Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success of Pulpal Anesthesia for Central Incisive	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Success of Pulpal Anesthesia for Lateral Incisive	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Success of Pulpal Anesthesia for Canine	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Success of Pulpal Anesthesia for First Premolar	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Success of Pulpal Anesthesia for Second Premolar	Measured by pulp sensitivity to electrical pulp tester	after 1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Onset Central Incisive	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Onset Lateral Incisive	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Onset Canine	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Onset First Premolar	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Onset Second Premolar	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Duration Central Incisive	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Duration Lateral Incisive	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Duration Canine	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Duration First Premolar	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Duration Second Premolar	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Systolic blood pressure	Measured noninvasively in mm Hg	baseline
Systolic blood pressure at 5th minute	Measured noninvasively in mm Hg	5th minute
Systolic blood pressure at 10th minute	Measured noninvasively in mm Hg	10th minute
Systolic blood pressure at 15th minute	Measured noninvasively in mm Hg	15th minute
Systolic blood pressure at 30th minute	Measured noninvasively in mm Hg	30th minute
Diastolic blood pressure	Measured noninvasively in mm Hg	baseline
Diastolic blood pressure at 5th minute	Measured noninvasively in mm Hg	5th minute
Diastolic blood pressure at 10th minute	Measured noninvasively in mm Hg	10th minute
Diastolic blood pressure at 15th minute	Measured noninvasively in mm Hg	15th minute
Diastolic blood pressure at 30th minute	Measured noninvasively in mm Hg	30th minute
Heart rate	Measured noninvasively in beats per minute	baseline
Heart rate at 5th minute	Measured noninvasively in beats per minute	5th minute
Heart rate at 10th minute	Measured noninvasively in beats per minute	10th minute
Heart rate at 15th minute	Measured noninvasively in beats per minute	15th minute
Heart rate at 30th minute	Measured noninvasively in beats per minute	30th minute

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Principal Investigator: Marija Milić, Research Associate, School of dental medicine, University of Belgrade; Principal Investigator: Vladimir Biočanin, Assistant Professor, Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Anticipated): July 1, 2017

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2018
• Last Update Submitted That Met QC Criteria: March 21, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: articaine; local anesthesia; AMSA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Carticaine
• Other Study ID Numbers: UBelgrade 784/2

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No