Efficacy and Safety of Administration of Different Doses of 4% Articaine.

October 15, 2024 updated by: Adrià Jorba García, University of Barcelona

Efficacy and Safety of Administration of Different Doses of 4% Articaine (1:100,000 Epinephrine) Using the Lower Dental Nerve Block Technique for Lower Third Molar Extraction. a Triple-blind Randomized Clinical Trial.

The goal of this triple-blind randomized clinical trial is to compare the efficacy and safety of administering one cartridge (1.8 mL) versus two cartridges of articaine 4% with epinephrine 1:100,000 for lower third molar extraction using the inferior alveolar nerve block technique.

The main questions it aims to answer are:

  • The injection of 3.6 ml of 4% articaine 1:100,000 has a higher anesthetic efficacy than a single injection of 1.8 ml of the same anesthetic.
  • The injection of 3.6 ml of 4% articaine 1:100,000 has a higher rate of adverse effects than a single injection of 1.8 ml of the same anesthetic.
  • The injection of 3.6 ml of 4% articaine 1:100,000 has a greater alteration of heart rate, oxygen saturation and systolic and diastolic blood pressure than a single injection of 1.8 ml of the same anesthetic.

The investigator (XA) will perform the anesthetic technique.

  • The investigator will administer a first anesthesia for NDI block with a cartridge of 4% articaine anesthetic at 1:100,000 . At the end, an envelope containing the assignment to the experimental or control group will be opened.

    • In the control group, a single cartridge of anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without the needle, in the same area, counting up to 30 seconds.
    • In the experimental group two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block.
  • After checking Vincent's sign, the vestibular (buccal nerve) infiltration will be performed in both groups with half a cartridge (0.9 ml) of the same anesthetic solution.
  • The latency of the anesthetic effect will be measured using a pulpometer.
  • Subsequently, a student of the Master's Degree in Oral Surgery of the University of Barcelona will perform the surgical intervention. The surgeons in charge of performing the extraction will not know to which group each patient belongs.
  • The collection of the variables and the postoperative controls will be carried out by the researcher who has not performed the anesthetic technique and who will not know the study group to which the patient belongs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain
        • Hospital Odontológic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients of legal age (≥18 years) requiring surgical extraction of a lower wisdom tooth (whether erupted, semi-erupted or included).
  • Patients without relevant systemic pathology (equal or lower than ASA II).
  • Sufficient intellectual capacity to understand the study, the informed consent and to adequately complete the questionnaires.

Exclusion Criteria:

  • Pregnant patients.
  • Patients with hypersensitivity to articaine or adrenaline.
  • Patients with uncontrolled systemic diseases.
  • Drugs or systemic diseases (ASA III or higher) and that contraindicate a surgical intervention or the use of anesthetics and/or vasoconstrictors.
  • Patients with relative or absolute contraindication of conventional analgesic or anti-inflammatory regimen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Two cartridges of anesthetic
Two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block.
Other: Efficacy and safety of administering 1 or two cartridges of anesthesia

The investigator will administer the first anesthesia for NDI block with a cartridge of 4% articaine anesthetic at 1:100,000 . At the end, an envelope containing the assignment to the experimental or control group will be opened.

In the control group, only the first anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without the needle, in the same area, counting up to 30 seconds.

In the experimental group two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block.
Active Comparator: Single cartridge of anesthetic
In the control group, a single cartridge of anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without needle, in the same area, counting up to 30 seconds.
Other: Efficacy and safety of administering 1 or two cartridges of anesthesia

The investigator will administer the first anesthesia for NDI block with a cartridge of 4% articaine anesthetic at 1:100,000 . At the end, an envelope containing the assignment to the experimental or control group will be opened.

In the control group, only the first anesthetic (1.8 mL of articaine 4% 1:100,000) will be injected and a second puncture will be simulated, contacting the syringe without the needle, in the same area, counting up to 30 seconds.

In the experimental group two anesthetic cartridges of articaine 4% 1:100,000 will be administered with the direct technique for the inferior alveolar nerve block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the efficacy of administering one or two cartridges of articaine 4% with epinephrine 1:100,000 using the direct approach of the lower dental nerve block
Time Frame: 1 hour

Determined by:

  • Achieving Vincent's sign within 6 minutes after injection.
  • Reporting a negative response to the pulpometer within 6 minutes after injection.
  • Absence of need for reanesthesia during the surgical procedure.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the safety of both techniques
Time Frame: 7 days
Determined by the appearance or absence of adverse effects, such as : Disorientation, dizziness, blurred vision, nausea, vomiting, tremors, convulsions, vasovagal syncope, paresthesia or trismus.
7 days
Determine the hemodynamic changes that occur during surgery.
Time Frame: 1 to 2 hours
Determined by the changes between the preoperative measurements and the postoperatives.
1 to 2 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: 7 days
Using a visual analog pain score from 0 to 10 centimeters at 2, 6, and 12 hours postoperatively and then daily until the seventh day after surgery.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2023

Primary Completion (Actual)

May 25, 2024

Study Completion (Actual)

October 2, 2024

Study Registration Dates

First Submitted

October 8, 2024

First Submitted That Met QC Criteria

October 15, 2024

First Posted (Actual)

October 16, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 15, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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