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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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03225326
Enrollment
0
Registered
2017-07-21
Start date
2016-12-31
Completion date
2017-07-31
Last updated
2018-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Local Anesthesia

Keywords

articaine, local anesthesia, AMSA

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.

Interventions

DRUGComputer 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)

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

Sponsors

University of Belgrade
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Success of Pulpal Anesthesia for Central Incisiveafter 1 hourMeasured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Lateral Incisiveafter 1 hourMeasured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Canineafter 1 hourMeasured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for First Premolarafter 1 hourMeasured by pulp sensitivity to electrical pulp tester
Success of Pulpal Anesthesia for Second Premolarafter 1 hourMeasured by pulp sensitivity to electrical pulp tester

Secondary

MeasureTime frameDescription
Duration Central Incisiveup to 60 minutesMeasured by pulp sensitivity to electrical pulp tester
Duration Lateral Incisiveup to 60 minutesMeasured by pulp sensitivity to electrical pulp tester
Duration Canineup to 60 minutesMeasured by pulp sensitivity to electrical pulp tester
Duration First Premolarup to 60 minutesMeasured by pulp sensitivity to electrical pulp tester
Duration Second Premolarup to 60 minutesMeasured by pulp sensitivity to electrical pulp tester
Systolic blood pressurebaselineMeasured noninvasively in mm Hg
Systolic blood pressure at 5th minute5th minuteMeasured noninvasively in mm Hg
Systolic blood pressure at 10th minute10th minuteMeasured noninvasively in mm Hg
Systolic blood pressure at 15th minute15th minuteMeasured noninvasively in mm Hg
Systolic blood pressure at 30th minute30th minuteMeasured noninvasively in mm Hg
Onset Central Incisiveup to 8 minutesMeasured by pulp sensitivity to electrical pulp tester
Diastolic blood pressure at 5th minute5th minuteMeasured noninvasively in mm Hg
Diastolic blood pressure at 10th minute10th minuteMeasured noninvasively in mm Hg
Diastolic blood pressure at 15th minute15th minuteMeasured noninvasively in mm Hg
Diastolic blood pressure at 30th minute30th minuteMeasured noninvasively in mm Hg
Heart ratebaselineMeasured noninvasively in beats per minute
Heart rate at 5th minute5th minuteMeasured noninvasively in beats per minute
Heart rate at 10th minute10th minuteMeasured noninvasively in beats per minute
Heart rate at 15th minute15th minuteMeasured noninvasively in beats per minute
Heart rate at 30th minute30th minuteMeasured noninvasively in beats per minute
Diastolic blood pressurebaselineMeasured noninvasively in mm Hg
Onset Lateral Incisiveup to 8 minutesMeasured by pulp sensitivity to electrical pulp tester
Onset Canineup to 8 minutesMeasured by pulp sensitivity to electrical pulp tester
Onset First Premolarup to 8 minutesMeasured by pulp sensitivity to electrical pulp tester
Onset Second Premolarup to 8 minutesMeasured by pulp sensitivity to electrical pulp tester

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026