Clinical trial NCT02440347: Effects of Articaine Computer-controlled and Conventional Delivery for Anterior and Middle Superior Alveolar Nerve Block
Official title: Efficacy and Safety of Pulpal Anesthesia After Anterior and Middle Superior Alveolar (AMSA) Nerve Block Obtained by Articaine Computer-controlled and Conventional Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Local Anesthesia
Keywords: local anesthesia
articaine
AMSA
Lead sponsor: University of Belgrade
Sponsor class: OTHER
First posted: 2015-05-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 in healthy volunteers.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of pulpal anesthesia
timeFrame: up to 64 minutes from baseline
Secondary outcomes:
measure: Onset of pulpal anesthesia
timeFrame: Up to 8 minutes
measure: Width of anesthetic field marginal-superior
timeFrame: 5 minutes
measure: Width of anesthetic field medial-lateral
timeFrame: 5 minutes
measure: Duration of soft tissue anesthesia buccal
timeFrame: Up to 120 min
measure: Duration of soft tissue anesthesia palatal
timeFrame: Up to 120 minutes
measure: Systolic blood pressure at baseline
timeFrame: 0 minutes
measure: Systolic blood pressure at 5 minutes
timeFrame: 0, 5 minutes
measure: Systolic blood pressure at 10 minutes
timeFrame: 0, 10 minutes
measure: Systolic blood pressure at 15 minutes
timeFrame: 0, 15 minutes
measure: Systolic blood pressure at 20 minutes
timeFrame: 0, 20 minutes
measure: Systolic blood pressure at 35 minutes
timeFrame: 0, 35 minutes
measure: Diastolic blood pressure at baseline
timeFrame: 0 minutes
measure: Diastolic blood pressure at 5 minutes
timeFrame: 0, 5 minutes
measure: Diastolic blood pressure at 10 minutes
timeFrame: 0, 10 minutes
measure: Diastolic blood pressure at 15 minutes
timeFrame: 0, 15 minutes
measure: Diastolic blood pressure at 20 minutes
timeFrame: 0, 20 minutes
measure: Diastolic blood pressure at 35 minutes
timeFrame: 0, 35 minutes
measure: Heart rate at baseline
timeFrame: 0 minutes
measure: Heart rate at 5 minutes
timeFrame: 0, 5 mninutes
measure: Heart rate at 10 minutes
timeFrame: 0, 10 minutes
measure: Heart rate at 15 minutes
timeFrame: 0, 15 minutes
measure: Heart rate at 20 minutes
timeFrame: 0, 20 minutes
measure: Heart rate at 35 minutes
timeFrame: 0, 35 minutes
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: School of Dental Medicine, University of Belgrade
Study officials:
affiliation: School of Dental Medicine, University of Belgrade
name: Bozidar M Brkovic, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Dental Medicine, University of Belgrade
name: Dejan Cetkovic, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Pharmacy and Health, University of Travnik, Bosnia and Herzegovina
name: Vladimir M Biocanin, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Dental Medicine, University of Belgrade
name: Marija S Milic, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: School of Dental Medicine, University of Belgrade
name: Ivana Brajic, DDS
role: PRINCIPAL_INVESTIGATOR
References: