Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06641232
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-11
Brief Title:
Comparison of Anesthetic Efficacy and Safety Between Nerve Block and Infiltrative Technique for Mandibular Posterior Implant Placement
Sponsor:
None
Organization:
None
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:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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 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 Masters 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 Masters 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:
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