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

NCT ID: NCT03225326

Last Updated: 2018-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-07-31

Brief Summary

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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

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Conditions

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Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Computer controlled 4% articaine delivery by Anaeject

Group Type EXPERIMENTAL

Computer controlled 4% articaine delivery by Anaeject

Intervention Type DRUG

Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject)

Conventional 4% articaine delivery by carpule syringe

Group Type ACTIVE_COMPARATOR

Conventional 4% articaine delivery by carpule syringe

Intervention Type DRUG

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

Interventions

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Computer 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)

Intervention Type DRUG

Conventional 4% articaine delivery by carpule syringe

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Belgrade

OTHER

Sponsor Role lead

Responsible Party

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Bozidar Brkovic, DDS, MSc, PhD, Professor

DDS PhD Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marija Milić, Research Associate

Role: PRINCIPAL_INVESTIGATOR

School of Dental Medicine, University of Belgrade

Vladimir Biočanin, Assistant Professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina

Locations

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School of Dental Medicine, University of Belgrade

Belgrade, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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UBelgrade 784/2

Identifier Type: -

Identifier Source: org_study_id

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