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

Local Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03225326
• Other study ID #: UBelgrade 784/2
• Status: Withdrawn
• Phase: Phase 4
• First received: July 17, 2017
• Last updated: March 21, 2018
• Start date: December 2016
• Est. completion date: July 2017

Study information

• Verified date: March 2018
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 for maxillary teeth extraction.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

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)
• 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).

Locations

Country	Name	City	State
Serbia	School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of Pulpal Anesthesia for Central Incisive	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Primary	Success of Pulpal Anesthesia for Lateral Incisive	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Primary	Success of Pulpal Anesthesia for Canine	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Primary	Success of Pulpal Anesthesia for First Premolar	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Primary	Success of Pulpal Anesthesia for Second Premolar	Measured by pulp sensitivity to electrical pulp tester	after 1 hour
Secondary	Onset Central Incisive	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Secondary	Onset Lateral Incisive	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Secondary	Onset Canine	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Secondary	Onset First Premolar	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Secondary	Onset Second Premolar	Measured by pulp sensitivity to electrical pulp tester	up to 8 minutes
Secondary	Duration Central Incisive	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Secondary	Duration Lateral Incisive	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Secondary	Duration Canine	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Secondary	Duration First Premolar	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Secondary	Duration Second Premolar	Measured by pulp sensitivity to electrical pulp tester	up to 60 minutes
Secondary	Systolic blood pressure	Measured noninvasively in mm Hg	baseline
Secondary	Systolic blood pressure at 5th minute	Measured noninvasively in mm Hg	5th minute
Secondary	Systolic blood pressure at 10th minute	Measured noninvasively in mm Hg	10th minute
Secondary	Systolic blood pressure at 15th minute	Measured noninvasively in mm Hg	15th minute
Secondary	Systolic blood pressure at 30th minute	Measured noninvasively in mm Hg	30th minute
Secondary	Diastolic blood pressure	Measured noninvasively in mm Hg	baseline
Secondary	Diastolic blood pressure at 5th minute	Measured noninvasively in mm Hg	5th minute
Secondary	Diastolic blood pressure at 10th minute	Measured noninvasively in mm Hg	10th minute
Secondary	Diastolic blood pressure at 15th minute	Measured noninvasively in mm Hg	15th minute
Secondary	Diastolic blood pressure at 30th minute	Measured noninvasively in mm Hg	30th minute
Secondary	Heart rate	Measured noninvasively in beats per minute	baseline
Secondary	Heart rate at 5th minute	Measured noninvasively in beats per minute	5th minute
Secondary	Heart rate at 10th minute	Measured noninvasively in beats per minute	10th minute
Secondary	Heart rate at 15th minute	Measured noninvasively in beats per minute	15th minute
Secondary	Heart rate at 30th minute	Measured noninvasively in beats per minute	30th minute