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

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

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.

Study Overview

• Status: Completed
• Conditions: Local Anesthesia
• Intervention / Treatment: Device: Computer controlled anesthetic delivery by Anaeject; Device: Conventional anesthetic delivery by carpule syringe

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Serbia
  • Belgrade, Serbia, 11000
    • School of dental medicine, University of Belgrade

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Belgrade
• Investigators: Principal Investigator: Bozidar M Brkovic, DDS, PhD, School of dental medicine, University of Belgrade; Principal Investigator: Marija S Milic, DDS, School of dental medicine, University of Belgrade; Principal Investigator: Dejan Cetkovic, DDS, School of dental medicine, University of Belgrade; Principal Investigator: Vladimir M Biocanin, DDS, PhD, Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina; Principal Investigator: Ivana Brajic, DDS, School of dental medicine, University of Belgrade

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: May 6, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): July 24, 2015
• Last Update Submitted That Met QC Criteria: July 23, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: articaine; local anesthesia; AMSA
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 36/5-2015; 175021 (Other Grant/Funding Number: Ministry of Education, Science and Technological Development)