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

Phase 4

Completed

• Conditions: Local Anesthesia
• Interventions: Device: Conventional anesthetic delivery by carpule syringe; Device: Computer controlled anesthetic delivery by Anaeject

• Registration Number: NCT02440347
• Lead Sponsor: University of Belgrade

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-23
• Last Update Posted: 2015-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ASA I
• full maxillary dental arch
• vital maxillary teeth without caries, restorations, periodontal disease or history of trauma

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Exclusion Criteria

• allergies to local anesthetic solution ingredients, food and drugs
• alcohol and drugs abuse
• heavy tobacco smoking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional anesthetic delivery by carpule syringe	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
Computer controlled anesthetic delivery by Anaeject	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

Primary Outcome Measures

Name	Time	Method
Duration of pulpal anesthesia	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

School of Dental Medicine, University of Belgrade; 🇷🇸 Belgrade, Serbia