Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-26 @ 5:00 PM
Study NCT ID:
NCT06641232
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2024-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement.
Sponsor:
University of Barcelona
Organization:
Study Overview
Official Title:
Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement. a Triple-blind Randomized Clinical Trial.
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 safety, efficacy and postoperative pain between the inferior dental nerve block (IDNB) and the infiltrative technique (TINF) in the placement of mandibular posterior dental implants in patients with partial edentulism.
The main questions it aims to answer are:
* The anesthetic efficacy of the IDNB technique, measured as the number of reanesthesias during the surgical procedure, is superior to the infiltrative technique in the placement of dental implants in the posterior mandibular area.
* The IDNB technique presents a higher rate of adverse effects than TINF in the placement of dental implants in the posterior mandibular area.
* The IDNB technique presents less postoperative pain than TINF in the placement of dental implants in the posterior mandibular area.
The investigator (XA) will perform the anesthetic technique. A modified dental anxiety questionnaire (MDAS) will be administered prior to surgery. Then, 2g of Amoxicillin will be administered 1 hour before the surgery. Subsequently, the surgeon and his assistant will prepare the surgical field with sterile sizes. The surgeon and assistant will then leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.
The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo IDNB together with buccal nerve block.
The anesthetic latency time will be determined by using a pulpometer on the most posterior tooth in the arch.
Failure to achieve sufficient anesthetic depth, as measured by pulpometer, within 6 minutes of the last puncture will be considered early anesthetic failure and will be counted as such.
* 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 surgery 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 anesthetic efficacy of the IDNB technique, measured as the number of reanesthesias during the surgical procedure, is superior to the infiltrative technique in the placement of dental implants in the posterior mandibular area.
* The IDNB technique presents a higher rate of adverse effects than TINF in the placement of dental implants in the posterior mandibular area.
* The IDNB technique presents less postoperative pain than TINF in the placement of dental implants in the posterior mandibular area.
The investigator (XA) will perform the anesthetic technique. A modified dental anxiety questionnaire (MDAS) will be administered prior to surgery. Then, 2g of Amoxicillin will be administered 1 hour before the surgery. Subsequently, the surgeon and his assistant will prepare the surgical field with sterile sizes. The surgeon and assistant will then leave the operating room and the study investigator in charge of anesthetizing the patients (XA) will enter.
The anesthesia will be performed by an investigator other than the surgeon performing the procedure. The patient will be assigned to a treatment group; patients in the control group will undergo vestibular and lingual infiltration, while the experimental group will undergo IDNB together with buccal nerve block.
The anesthetic latency time will be determined by using a pulpometer on the most posterior tooth in the arch.
Failure to achieve sufficient anesthetic depth, as measured by pulpometer, within 6 minutes of the last puncture will be considered early anesthetic failure and will be counted as such.
* 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 surgery 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:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: