Clinical trial NCT03225326: Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block for Tooth Extraction
Official title: Efficacy of Anterior and Middle Superior Alveolar (AMSA) Nerve Block Anesthesia Obtained by Articaine Computer-controlled and Conventional Delivery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Local Anesthesia
Keywords: articaine
local anesthesia
AMSA
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Success of Pulpal Anesthesia for Central Incisive
timeFrame: after 1 hour
measure: Success of Pulpal Anesthesia for Lateral Incisive
timeFrame: after 1 hour
measure: Success of Pulpal Anesthesia for Canine
timeFrame: after 1 hour
measure: Success of Pulpal Anesthesia for First Premolar
timeFrame: after 1 hour
measure: Success of Pulpal Anesthesia for Second Premolar
timeFrame: after 1 hour
Secondary outcomes:
measure: Onset Central Incisive
timeFrame: up to 8 minutes
measure: Onset Lateral Incisive
timeFrame: up to 8 minutes
measure: Onset Canine
timeFrame: up to 8 minutes
measure: Onset First Premolar
timeFrame: up to 8 minutes
measure: Onset Second Premolar
timeFrame: up to 8 minutes
measure: Duration Central Incisive
timeFrame: up to 60 minutes
measure: Duration Lateral Incisive
timeFrame: up to 60 minutes
measure: Duration Canine
timeFrame: up to 60 minutes
measure: Duration First Premolar
timeFrame: up to 60 minutes
measure: Duration Second Premolar
timeFrame: up to 60 minutes
measure: Systolic blood pressure
timeFrame: baseline
measure: Systolic blood pressure at 5th minute
timeFrame: 5th minute
measure: Systolic blood pressure at 10th minute
timeFrame: 10th minute
measure: Systolic blood pressure at 15th minute
timeFrame: 15th minute
measure: Systolic blood pressure at 30th minute
timeFrame: 30th minute
measure: Diastolic blood pressure
timeFrame: baseline
measure: Diastolic blood pressure at 5th minute
timeFrame: 5th minute
measure: Diastolic blood pressure at 10th minute
timeFrame: 10th minute
measure: Diastolic blood pressure at 15th minute
timeFrame: 15th minute
measure: Diastolic blood pressure at 30th minute
timeFrame: 30th minute
measure: Heart rate
timeFrame: baseline
measure: Heart rate at 5th minute
timeFrame: 5th minute
measure: Heart rate at 10th minute
timeFrame: 10th minute
measure: Heart rate at 15th minute
timeFrame: 15th minute
measure: Heart rate at 30th minute
timeFrame: 30th minute
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: School of Dental Medicine, University of Belgrade
Study officials:
affiliation: School of Dental Medicine, University of Belgrade
name: Marija Milić, Research Associate
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina
name: Vladimir Biočanin, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References: