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

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 in healthy volunteers.

Detailed Description
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Traditionally, pulpal anesthesia is obtained by infiltration or mandibular nerve block. However, it is not always possible to achieve complete pulpal anesthesia with previously mentioned anesthetic techniques. It is well documented that administration of 0,6-0,9 ml of anesthetic solution with palatal approach with anterior middle superior injection (AMSA) provided successful pulpal anesthesia from central incisor to second premolar. In addition, palatal soft tissues from midpalate to free gingiva and from central incisor to first molar are fully anesthetized with AMSA. The injection site is located at a point that bisects the maxillary first and second premolars, and midway between the crest of the free gingival margin and mid-palatine suture. The needle is orientated at a 45-degree angle with the bevel facing the palatal tissue. AMSA presents intraosseous anesthetic technique. Traditionally, palatal injection administered with conventional syringe was described as very painful. On the other hand, computer controlled local anesthetic delivery system (CCLADS) has been recommended for AMSA as a system which allows slow administration of anesthetic solution, with constant pressure. It was shown that AMSA do not provide undesired buccal and upper lip anesthesia. The AMSA technique has been recommended for proce¬dures ranging from operative restorations, crown preparation to scaling and root planning. The aim of this study is to evaluate and compare parameters of pulpal anesthesia and cardiovascular function after AMSA injection of 4% articaine with epinephrine (1:100.000), delivered by conventional syringe or CCLADS. Study sample will comprise 30 healthy (ASA1) volunteers who will receive 0.6 ml 4% articaine with epinephrine (1:100.000) by conventional syringe, and after two-week washout period the same amount of local anesthetic by CCLADS. Parameters of pulpal and soft tissue anesthesia (onset and duration) for all maxillary teeth on the anesthetized side, as well as parameters of cardiovascular function (systolic blood pressure, diastolic blood pressure, heart rate) will be monitored and compared.

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

Conditions
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Local Anesthesia

Intervention / Treatment
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* Device: Computer controlled anesthetic delivery by Anaeject
* Device: Conventional anesthetic delivery by carpule syringe


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA I full maxillary dental arch vital maxillary teeth without caries, restorations, periodontal disease or history of trauma 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: 30 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 anesthetic delivery by Anaeject<br>Patients received single dose of 0.6 ml of 4% articaine with epinephrine (1:100.000) by computer controlled anesthetic delivery system (C-CLADS) for AMSA nerve block | Device: Computer controlled anesthetic 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 anesthetic delivery by carpule syringe<br>Patients received single dose of 0.6 ml of 4% articaine with epinephrine (1:100.000) by conventional anesthetic delivery for AMSA nerve block | Device: Conventional anesthetic 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 |
| --- | --- | --- |
| Duration of pulpal anesthesia | Duration of pulpal maxillary anesthesia of all maxillary teeth in anesthetized side of upper jaw assessed by electrical pulp testing at 2-minute intervals. | up to 64 minutes from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of pulpal anesthesia | Pulpal response to electrical pulp tester measured up to 8 minutes after injection | Up to 8 minutes | 
| Width of anesthetic field marginal-superior | Width of area of soft tissue numbness measured 5 minutes after injection | 5 minutes | 
| Width of anesthetic field medial-lateral | Width of area of soft tissue numbness measured 5 minutes after injection | 5 minutes | 
| Duration of soft tissue anesthesia buccal | Duration of soft tissue numbness followed up to 120 minutes after injection | Up to 120 min | 
| Duration of soft tissue anesthesia palatal | Duration of soft tissue numbness followed up to 120 minutes after injection | Up to 120 minutes | 
| Systolic blood pressure at baseline | Systolic blood pressure before injection | 0 minutes | 
| Systolic blood pressure at 5 minutes | Changes in systolic blood pressure from baseline at the time of injection delivery | 0, 5 minutes | 
| Systolic blood pressure at 10 minutes | Changes in systolic blood pressure from baseline 5 minutes after injection delivery | 0, 10 minutes | 
| Systolic blood pressure at 15 minutes | Changes in systolic blood pressure from baseline 10 minutes after injection delivery | 0, 15 minutes | 
| Systolic blood pressure at 20 minutes | Changes in systolic blood pressure from baseline 15 minutes after injection delivery | 0, 20 minutes | 
| Systolic blood pressure at 35 minutes | Changes in systolic blood pressure from baseline 30 minutes after injection delivery | 0, 35 minutes | 
| Diastolic blood pressure at baseline | Diastolic blood pressure before injection | 0 minutes | 
| Diastolic blood pressure at 5 minutes | Changes in diastolic blood pressure from baseline at the time of injection delivery | 0, 5 minutes | 
| Diastolic blood pressure at 10 minutes | Changes in diastolic blood pressure from baseline 5 minutes after injection delivery | 0, 10 minutes | 
| Diastolic blood pressure at 15 minutes | Changes in diastolic blood pressure from baseline 10 minutes after injection delivery | 0, 15 minutes | 
| Diastolic blood pressure at 20 minutes | Changes in diastolic blood pressure from baseline 15 minutes after injection delivery | 0, 20 minutes | 
| Diastolic blood pressure at 35 minutes | Changes in diastolic blood pressure from baseline 30 minutes after injection delivery | 0, 35 minutes | 
| Heart rate at baseline | Heart rate before injection delivery | 0 minutes | 
| Heart rate at 5 minutes | Changes in heart rate from baseline at the time of injection delivery | 0, 5 mninutes | 
| Heart rate at 10 minutes | Changes in heart rate from baseline 5 minutes after injection delivery | 0, 10 minutes | 
| Heart rate at 15 minutes | Changes in heart rate from baseline 10 minutes after injection delivery | 0, 15 minutes | 
| Heart rate at 20 minutes | Changes in heart rate from baseline 15 minutes after injection delivery | 0, 20 minutes | 
| Heart rate at 35 minutes | Changes in heart rate from baseline 30 minutes after injection delivery | 0, 35 minutes | 

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