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

Phase 4

Withdrawn

• Conditions: Local Anesthesia
• Interventions: Drug: Computer controlled 4% articaine delivery by Anaeject; Drug: Conventional 4% articaine delivery by carpule syringe

• Registration Number: NCT03225326
• Lead Sponsor: University of Belgrade

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 for maxillary teeth extraction.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-21
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-21
• Last Update Posted: 2018-03-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Computer controlled 4% articaine delivery by Anaeject	Computer controlled 4% articaine delivery by Anaeject	-
Conventional 4% articaine delivery by carpule syringe	Conventional 4% articaine delivery by carpule syringe	-

Primary Outcome Measures

Name	Time	Method
Success of Pulpal Anesthesia for First Premolar	after 1 hour	Measured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Central Incisive	after 1 hour	Measured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Lateral Incisive	after 1 hour	Measured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Canine	after 1 hour	Measured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Second Premolar	after 1 hour	Measured by pulp sensitivity to electrical pulp tester

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Dental Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia