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

Study Overview
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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.

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

Conditions
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Local Anesthesia

Intervention / Treatment
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* Drug: Computer controlled 4% articaine delivery by Anaeject
* Drug: Conventional 4% articaine delivery by carpule syringe


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computer controlled 4% articaine delivery by Anaeject<br> | Drug: Computer controlled 4% articaine delivery by Anaeject<br>* Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject)<br>|
| Active Comparator: Conventional 4% articaine delivery by carpule syringe<br> | Drug: Conventional 4% articaine delivery by carpule syringe<br>* Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Pulpal Anesthesia for Central Incisive | Measured by pulp sensitivity to electrical pulp tester | after 1 hour | 
| Success of Pulpal Anesthesia for Lateral Incisive | Measured by pulp sensitivity to electrical pulp tester | after 1 hour | 
| Success of Pulpal Anesthesia for Canine | Measured by pulp sensitivity to electrical pulp tester | after 1 hour | 
| Success of Pulpal Anesthesia for First Premolar | Measured by pulp sensitivity to electrical pulp tester | after 1 hour | 
| Success of Pulpal Anesthesia for Second Premolar | Measured by pulp sensitivity to electrical pulp tester | after 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset Central Incisive | Measured by pulp sensitivity to electrical pulp tester | up to 8 minutes | 
| Onset Lateral Incisive | Measured by pulp sensitivity to electrical pulp tester | up to 8 minutes | 
| Onset Canine | Measured by pulp sensitivity to electrical pulp tester | up to 8 minutes | 
| Onset First Premolar | Measured by pulp sensitivity to electrical pulp tester | up to 8 minutes | 
| Onset Second Premolar | Measured by pulp sensitivity to electrical pulp tester | up to 8 minutes | 
| Duration Central Incisive | Measured by pulp sensitivity to electrical pulp tester | up to 60 minutes | 
| Duration Lateral Incisive | Measured by pulp sensitivity to electrical pulp tester | up to 60 minutes | 
| Duration Canine | Measured by pulp sensitivity to electrical pulp tester | up to 60 minutes | 
| Duration First Premolar | Measured by pulp sensitivity to electrical pulp tester | up to 60 minutes | 
| Duration Second Premolar | Measured by pulp sensitivity to electrical pulp tester | up to 60 minutes | 
| Systolic blood pressure | Measured noninvasively in mm Hg | baseline | 
| Systolic blood pressure at 5th minute | Measured noninvasively in mm Hg | 5th minute | 
| Systolic blood pressure at 10th minute | Measured noninvasively in mm Hg | 10th minute | 
| Systolic blood pressure at 15th minute | Measured noninvasively in mm Hg | 15th minute | 
| Systolic blood pressure at 30th minute | Measured noninvasively in mm Hg | 30th minute | 
| Diastolic blood pressure | Measured noninvasively in mm Hg | baseline | 
| Diastolic blood pressure at 5th minute | Measured noninvasively in mm Hg | 5th minute | 
| Diastolic blood pressure at 10th minute | Measured noninvasively in mm Hg | 10th minute | 
| Diastolic blood pressure at 15th minute | Measured noninvasively in mm Hg | 15th minute | 
| Diastolic blood pressure at 30th minute | Measured noninvasively in mm Hg | 30th minute | 
| Heart rate | Measured noninvasively in beats per minute | baseline | 
| Heart rate at 5th minute | Measured noninvasively in beats per minute | 5th minute | 
| Heart rate at 10th minute | Measured noninvasively in beats per minute | 10th minute | 
| Heart rate at 15th minute | Measured noninvasively in beats per minute | 15th minute | 
| Heart rate at 30th minute | Measured noninvasively in beats per minute | 30th minute | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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articaine, local anesthesia, AMSA