School of Dental Medicine, University of Belgrade
Belgrade, 11000, Serbia
NCT Number: NCT02440347
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.
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Notify Me18 year–30 year
All sexes
Interventional
Phase 4
Belgrade, 11000, Serbia
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject).
Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).
Time frame: up to 64 minutes from baseline
Duration of pulpal maxillary anesthesia of all maxillary teeth in anesthetized side of upper jaw assessed by electrical pulp testing at 2-minute intervals.
Time frame: Up to 8 minutes
Pulpal response to electrical pulp tester measured up to 8 minutes after injection
Time frame: 5 minutes
Width of area of soft tissue numbness measured 5 minutes after injection
Time frame: 5 minutes
Width of area of soft tissue numbness measured 5 minutes after injection
Time frame: Up to 120 min
Duration of soft tissue numbness followed up to 120 minutes after injection
Time frame: Up to 120 minutes
Duration of soft tissue numbness followed up to 120 minutes after injection
Time frame: 0 minutes
Systolic blood pressure before injection
Time frame: 0, 5 minutes
Changes in systolic blood pressure from baseline at the time of injection delivery
Time frame: 0, 10 minutes
Changes in systolic blood pressure from baseline 5 minutes after injection delivery
Time frame: 0, 15 minutes
Changes in systolic blood pressure from baseline 10 minutes after injection delivery
Time frame: 0, 20 minutes
Changes in systolic blood pressure from baseline 15 minutes after injection delivery
Time frame: 0, 35 minutes
Changes in systolic blood pressure from baseline 30 minutes after injection delivery
Time frame: 0 minutes
Diastolic blood pressure before injection
Time frame: 0, 5 minutes
Changes in diastolic blood pressure from baseline at the time of injection delivery
Time frame: 0, 10 minutes
Changes in diastolic blood pressure from baseline 5 minutes after injection delivery
Time frame: 0, 15 minutes
Changes in diastolic blood pressure from baseline 10 minutes after injection delivery
Time frame: 0, 20 minutes
Changes in diastolic blood pressure from baseline 15 minutes after injection delivery
Time frame: 0, 35 minutes
Changes in diastolic blood pressure from baseline 30 minutes after injection delivery
Time frame: 0 minutes
Heart rate before injection delivery
Time frame: 0, 5 mninutes
Changes in heart rate from baseline at the time of injection delivery
Time frame: 0, 10 minutes
Changes in heart rate from baseline 5 minutes after injection delivery
Time frame: 0, 15 minutes
Changes in heart rate from baseline 10 minutes after injection delivery
Time frame: 0, 20 minutes
Changes in heart rate from baseline 15 minutes after injection delivery
Time frame: 0, 35 minutes
Changes in heart rate from baseline 30 minutes after injection delivery
University of Belgrade
Other
Efficacy and Safety of Pulpal Anesthesia After Anterior and Middle Superior Alveolar (AMSA) Nerve Block Obtained by Articaine Computer-controlled and Conventional Delivery
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