Clinical trial NCT06644950: Efficacy and Safety of Administration of Different Doses of 4% Articaine.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction Status Nos
Anesthesia, Local
Keywords: anesthesia
block nerve
wisdom tooth
wisdom tooth extraction
Lead sponsor: University of Barcelona
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 hour
Secondary outcomes:
measure: To compare the safety of both techniques
timeFrame: 7 days
measure: Determine the hemodynamic changes that occur during surgery.
timeFrame: 1 to 2 hours
Other outcomes:
measure: Post-operative pain
timeFrame: 7 days
Locations:
city: L'Hospitalet De Llobregat
country: Spain
facility: Hospital Odontológic de Barcelona
state: Barcelona
Study officials:
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