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

NCT06644950 | Completed DMC

• 1 other identifier: 28/2022
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tooth Extraction Status Nos; Anesthesia, Local

Keywords

anesthesia; block nerve; wisdom tooth; wisdom tooth extraction

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (2)

• To compare the safety of both techniques

  7 days

• Determine the hemodynamic changes that occur during surgery.

  1 to 2 hours

Other Outcomes (1)

• Post-operative pain

  7 days

Study Arms (2)

Two cartridges of anesthetic

EXPERIMENTAL

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

Single cartridge of anesthetic

ACTIVE COMPARATOR

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

Interventions

Efficacy and safety of administering 1 or two cartridges of anesthesia OTHER

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.

Single cartridge of anesthetic; Two cartridges of anesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital Odontológic de Barcelona

L'Hospitalet de Llobregat, Barcelona, Spain

Location

Related Publications (25)

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr (DDS, MS,PhD)

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 16, 2024
• Study Start: May 25, 2023
• Primary Completion: May 25, 2024
• Study Completion: October 2, 2024
• Last Updated: October 16, 2024

Record last verified: 2022-10

Locations

ES (1)