An interventional study of Efficacy and safety of administering 1 or two cartridges of anesthesia in Tooth Extraction Status Nos and Anesthesia, Local, sponsored by University of Barcelona. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.
Sponsored by University of Barcelona · Not applicable, Interventional, and Treatment
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 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.
University of Barcelona is the lead sponsor of 95 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
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.
Time frame: 1 hour
To compare the safety of both techniques
Determined by the appearance or absence of adverse effects, such as : Disorientation, dizziness, blurred vision, nausea, vomiting, tremors, convulsions, vasovagal syncope, paresthesia or trismus.
Time frame: 7 days
Determine the hemodynamic changes that occur during surgery.
Determined by the changes between the preoperative measurements and the postoperatives.
Time frame: 1 to 2 hours
Post-operative pain
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.
Time frame: 7 days
Plan to share: Undecided
This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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University of Barcelona