Efficacy and Safety of Administration of Different Doses of 4% Articaine.
NCT ID: NCT06644950
Last Updated: 2024-10-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2023-05-25
2024-10-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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University of Barcelona
OTHER
Responsible Party
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Adrià Jorba García
Prof. dr (DDS, MS,PhD)
Locations
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Hospital Odontológic de Barcelona
L'Hospitalet de Llobregat, Barcelona, Spain
Countries
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References
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Ku JK, Kim JY, Jun MK, Jeong YK, Huh JK. Influence of General and Local Anesthesia on Postoperative Pain after Impacted Third Molar Surgery. J Clin Med. 2021 Jun 17;10(12):2674. doi: 10.3390/jcm10122674.
Sainz de Baranda B, Silvestre FJ, Silvestre-Rangil J. Relationship Between Surgical Difficulty of Third Molar Extraction Under Local Anesthesia and the Postoperative Evolution of Clinical and Blood Parameters. J Oral Maxillofac Surg. 2019 Jul;77(7):1337-1345. doi: 10.1016/j.joms.2019.02.020. Epub 2019 Feb 20.
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Madan GA, Madan SG, Madan AD. Failure of inferior alveolar nerve block: exploring the alternatives. J Am Dent Assoc. 2002 Jul;133(7):843-6. doi: 10.14219/jada.archive.2002.0298.
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Other Identifiers
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28/2022
Identifier Type: -
Identifier Source: org_study_id
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