Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06644950
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Efficacy and Safety of Administration of Different Doses of 4 Articaine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Administration of Different Doses of 4 Articaine 1100000 Epinephrine Using the Lower Dental Nerve Block Technique for Lower Third Molar Extraction a Triple-blind Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this triple-blind randomized clinical trial is to compare the efficacy and safety of administering one cartridge 18 mL versus two cartridges of articaine 4 with epinephrine 1100000 for lower third molar extraction using the inferior alveolar nerve block technique
The main questions it aims to answer are
The injection of 36 ml of 4 articaine 1100000 has a higher anesthetic efficacy than a single injection of 18 ml of the same anesthetic
The injection of 36 ml of 4 articaine 1100000 has a higher rate of adverse effects than a single injection of 18 ml of the same anesthetic
The injection of 36 ml of 4 articaine 1100000 has a greater alteration of heart rate oxygen saturation and systolic and diastolic blood pressure than a single injection of 18 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 1100000 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 18 mL of articaine 4 1100000 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 1100000 will be administered with the direct technique for the inferior alveolar nerve block
After checking Vincents sign the vestibular buccal nerve infiltration will be performed in both groups with half a cartridge 09 ml of the same anesthetic solution
The latency of the anesthetic effect will be measured using a pulpometer
Subsequently a student of the Masters 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
The main questions it aims to answer are
The injection of 36 ml of 4 articaine 1100000 has a higher anesthetic efficacy than a single injection of 18 ml of the same anesthetic
The injection of 36 ml of 4 articaine 1100000 has a higher rate of adverse effects than a single injection of 18 ml of the same anesthetic
The injection of 36 ml of 4 articaine 1100000 has a greater alteration of heart rate oxygen saturation and systolic and diastolic blood pressure than a single injection of 18 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 1100000 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 18 mL of articaine 4 1100000 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 1100000 will be administered with the direct technique for the inferior alveolar nerve block
After checking Vincents sign the vestibular buccal nerve infiltration will be performed in both groups with half a cartridge 09 ml of the same anesthetic solution
The latency of the anesthetic effect will be measured using a pulpometer
Subsequently a student of the Masters 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None