Ignite Creation Date:
2024-05-06 @ 2:42 PM
Last Modification Date:
2024-10-26 @ 1:35 PM
Study NCT ID:
NCT04395690
Status:
COMPLETED
Last Update Posted:
2021-08-31
First Post:
2020-05-12
Brief Title:
Comparing Two Anesthetic Techniques for Implant Placement
Sponsor:
Aula Dental Avanzada
Organization:
Aula Dental Avanzada
Study Overview
Official Title:
Prospective Randomized Multicenter Study Between Two Anesthetic Techniques for Implant Placement in the Posterior Mandible
Status:
COMPLETED
Status Verified Date:
2024-07
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:
To evaluate in a comparative way the patients perception in implant surgery in the posterior mandibular quadrants depending on whether the operation is performed under trunk anaesthesia or infiltrative anaesthesia in both cases with Articaine
Randomized and multicenter prospective study to be developed in eight centers with similar socio-professional characteristics with the same operative protocol
A significant sample of patients will be randomized to undergo the same intervention surgery to place implants in the posterior mandible under one or another type of anesthesia inferior alveolar block nerve or infiltrative and data will be collected using a Numerical Rate scale on four occasions after the incision after drilling after suturing and after 12h
Randomized and multicenter prospective study to be developed in eight centers with similar socio-professional characteristics with the same operative protocol
A significant sample of patients will be randomized to undergo the same intervention surgery to place implants in the posterior mandible under one or another type of anesthesia inferior alveolar block nerve or infiltrative and data will be collected using a Numerical Rate scale on four occasions after the incision after drilling after suturing and after 12h
Detailed Description:
The optimal anesthesia for posterior mandibular implant surgery remains controversial and dependent on operators preferences Although not evidence-based most operators usually avoid infiltration anesthesia in the posterior mandible due to its uncertain efficacy However various comparative studies with articaine 4 have not found differences between infiltration INF and inferior alveolar nerve block IANB but current research is still conflicting
Infiltration anesthesia is easier for the operator and more tolerable for the patient Should it were sufficient for surgical procedures in the posterior mandible it could become the first option in routine surgeries
The purpose of this prospective randomized and multicenter study is to clarify the efficacy of infiltration anesthesia for placing implants in the posterior mandible
The study will take place in eight centers with similar socio-professional characteristics and the same operative protocol The study has been approved by the Ethical Research Committee of the University Hospital of San Juan Alicante Spain
On a significant sample of patients 96n that meet the in-exclusion criteria the same intervention implant placement surgery in posterior area of the mandible has been carried out randomly List Randomizer wwwrandomorglists with one or another type of anesthesia group A IANB or group B INF
Data of pain perception from patients were collected intraoperatively by means of a Numerical Rating Scale in three moments after incision after drilling after suturing and global satisfaction one week post surgery
Five confounding variables were also recorded gender use of release incision number of implants placed wether or not Guided Bone Regeneration GBR was applied and the distance from the implant apex to the mandibular canal A non-parametric statistical analysis was applied
Infiltration anesthesia is easier for the operator and more tolerable for the patient Should it were sufficient for surgical procedures in the posterior mandible it could become the first option in routine surgeries
The purpose of this prospective randomized and multicenter study is to clarify the efficacy of infiltration anesthesia for placing implants in the posterior mandible
The study will take place in eight centers with similar socio-professional characteristics and the same operative protocol The study has been approved by the Ethical Research Committee of the University Hospital of San Juan Alicante Spain
On a significant sample of patients 96n that meet the in-exclusion criteria the same intervention implant placement surgery in posterior area of the mandible has been carried out randomly List Randomizer wwwrandomorglists with one or another type of anesthesia group A IANB or group B INF
Data of pain perception from patients were collected intraoperatively by means of a Numerical Rating Scale in three moments after incision after drilling after suturing and global satisfaction one week post surgery
Five confounding variables were also recorded gender use of release incision number of implants placed wether or not Guided Bone Regeneration GBR was applied and the distance from the implant apex to the mandibular canal A non-parametric statistical analysis was applied
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None