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

Local Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440347
• Other study ID #: 36/5-2015
• Secondary ID: 175021
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2015
• Last updated: July 23, 2015
• Start date: June 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Local Anesthesia

Intervention

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).
• Conventional anesthetic delivery by carpule syringe
Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).

Locations

Country	Name	City	State
Serbia	School of Dental Medicine, University of Belgrade	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Onset of pulpal anesthesia	Pulpal response to electrical pulp tester measured up to 8 minutes after injection	Up to 8 minutes	No
Secondary	Width of anesthetic field marginal-superior	Width of area of soft tissue numbness measured 5 minutes after injection	5 minutes	No
Secondary	Width of anesthetic field medial-lateral	Width of area of soft tissue numbness measured 5 minutes after injection	5 minutes	No
Secondary	Duration of soft tissue anesthesia buccal	Duration of soft tissue numbness followed up to 120 minutes after injection	Up to 120 min	No
Secondary	Duration of soft tissue anesthesia palatal	Duration of soft tissue numbness followed up to 120 minutes after injection	Up to 120 minutes	No
Secondary	Systolic blood pressure at baseline	Systolic blood pressure before injection	0 minutes	Yes
Secondary	Systolic blood pressure at 5 minutes	Changes in systolic blood pressure from baseline at the time of injection delivery	0, 5 minutes	Yes
Secondary	Systolic blood pressure at 10 minutes	Changes in systolic blood pressure from baseline 5 minutes after injection delivery	0, 10 minutes	Yes
Secondary	Systolic blood pressure at 15 minutes	Changes in systolic blood pressure from baseline 10 minutes after injection delivery	0, 15 minutes	Yes
Secondary	Systolic blood pressure at 20 minutes	Changes in systolic blood pressure from baseline 15 minutes after injection delivery	0, 20 minutes	Yes
Secondary	Systolic blood pressure at 35 minutes	Changes in systolic blood pressure from baseline 30 minutes after injection delivery	0, 35 minutes	Yes
Secondary	Diastolic blood pressure at baseline	Diastolic blood pressure before injection	0 minutes	Yes
Secondary	Diastolic blood pressure at 5 minutes	Changes in diastolic blood pressure from baseline at the time of injection delivery	0, 5 minutes	Yes
Secondary	Diastolic blood pressure at 10 minutes	Changes in diastolic blood pressure from baseline 5 minutes after injection delivery	0, 10 minutes	Yes
Secondary	Diastolic blood pressure at 15 minutes	Changes in diastolic blood pressure from baseline 10 minutes after injection delivery	0, 15 minutes	Yes
Secondary	Diastolic blood pressure at 20 minutes	Changes in diastolic blood pressure from baseline 15 minutes after injection delivery	0, 20 minutes	Yes
Secondary	Diastolic blood pressure at 35 minutes	Changes in diastolic blood pressure from baseline 30 minutes after injection delivery	0, 35 minutes	Yes
Secondary	Heart rate at baseline	Heart rate before injection delivery	0 minutes	Yes
Secondary	Heart rate at 5 minutes	Changes in heart rate from baseline at the time of injection delivery	0, 5 mninutes	Yes
Secondary	Heart rate at 10 minutes	Changes in heart rate from baseline 5 minutes after injection delivery	0, 10 minutes	Yes
Secondary	Heart rate at 15 minutes	Changes in heart rate from baseline 10 minutes after injection delivery	0, 15 minutes	Yes
Secondary	Heart rate at 20 minutes	Changes in heart rate from baseline 15 minutes after injection delivery	0, 20 minutes	Yes
Secondary	Heart rate at 35 minutes	Changes in heart rate from baseline 30 minutes after injection delivery	0, 35 minutes	Yes