Efficacy of Anterior and Middle Superior Alveolar (AMSA) Nerve Block Anesthesia Obtained by Articaine Computer-controlled and Conventional Delivery
Trial Snapshot
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- University of Belgrade
- 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
Intervention: Computer controlled 4% articaine delivery by Anaeject (Drug)
Conventional 4% articaine delivery by carpule syringe
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
Bozidar Brkovic, DDS, MSc, PhD, Professor
DDS PhD Professor
University of Belgrade