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Clinical Trials/NCT03225326
NCT03225326WithdrawnPhase 4

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

University of Belgrade1 site in 1 countryStarted: December 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Locations
1
Primary Endpoint
Success of Pulpal Anesthesia for Central Incisive

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Arms & Interventions

Computer controlled 4% articaine delivery by Anaeject

Experimental

Intervention: Computer controlled 4% articaine delivery by Anaeject (Drug)

Conventional 4% articaine delivery by carpule syringe

Active Comparator

Intervention: Conventional 4% articaine delivery by carpule syringe (Drug)

Outcomes

Primary Outcomes

Success of Pulpal Anesthesia for Central Incisive

Time Frame: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Success of Pulpal Anesthesia for First Premolar

Time Frame: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Success of Pulpal Anesthesia for Lateral Incisive

Time Frame: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Success of Pulpal Anesthesia for Canine

Time Frame: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Success of Pulpal Anesthesia for Second Premolar

Time Frame: after 1 hour

Measured by pulp sensitivity to electrical pulp tester

Secondary Outcomes

  • Systolic blood pressure at 5th minute(5th minute)
  • Systolic blood pressure at 15th minute(15th minute)
  • Duration First Premolar(up to 60 minutes)
  • Heart rate(baseline)
  • Heart rate at 5th minute(5th minute)
  • Onset Lateral Incisive(up to 8 minutes)
  • Onset First Premolar(up to 8 minutes)
  • Duration Canine(up to 60 minutes)
  • Onset Canine(up to 8 minutes)
  • Onset Central Incisive(up to 8 minutes)
  • Duration Central Incisive(up to 60 minutes)
  • Onset Second Premolar(up to 8 minutes)
  • Duration Lateral Incisive(up to 60 minutes)
  • Diastolic blood pressure at 5th minute(5th minute)
  • Duration Second Premolar(up to 60 minutes)
  • Systolic blood pressure(baseline)
  • Systolic blood pressure at 10th minute(10th minute)
  • Systolic blood pressure at 30th minute(30th minute)
  • Diastolic blood pressure(baseline)
  • Diastolic blood pressure at 10th minute(10th minute)
  • Diastolic blood pressure at 15th minute(15th minute)
  • Diastolic blood pressure at 30th minute(30th minute)
  • Heart rate at 10th minute(10th minute)
  • Heart rate at 15th minute(15th minute)
  • Heart rate at 30th minute(30th minute)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bozidar Brkovic, DDS, MSc, PhD, Professor

DDS PhD Professor

University of Belgrade

Study Sites (1)

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