Ignite Creation Date:
2025-12-25 @ 3:13 AM
Ignite Modification Date:
2026-01-08 @ 2:41 AM
Study NCT ID:
NCT06059105
Status:
UNKNOWN
Last Update Posted:
2023-09-28
First Post:
2023-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Implant Using an Inverted Co-Axis at 12º Versus a Conventional Conical Implant
Sponsor:
Universitat Internacional de Catalunya
Organization:
Study Overview
Official Title:
Immediate Implant Using an Inverted Co-Axis at 12º Versus a Conventional Conical Implant: A Randomised Clinical Trial With 1 Year Follow-up
Status:
UNKNOWN
Status Verified Date:
2023-09
Last Known Status:
RECRUITING
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:
This study is a randomised controlled clinical trial. The patients will be included for the placement of immediate implants with immediate crown placement, to replace maxillary anterior teeth. Any significant differences between the Co-Axis implant and a conventional conical implant will be evaluated.
Detailed Description:
Introduction: It is commonly known that the placement of an immediate implant is a technique-sensitive procedure, as the implant should be placed in the palatal aspect for the perfect prosthetic emergence and profile. In order to supply this complexity, there is a novel macroimplant design involving an implant with a 12º angled platform. This angulation of the coronal part of the implant allows perfect emergence of the placement of post-extraction implants, since it is placed at the center of the socket, acquiring the best possible bone. In addition, thanks to the angled neck, prosthetic emergence is ideal, as it is corrected and emerges through the cingulate area, thus securing a perfect emergence profile.
Objectives:
Primary Outcomes: Evaluate the percentage of success and survival of the Inverted Co-Axis 12º Southern Implants versus the Internal Conical (Deep Tapered Conical) South Implants on a 1-2-1 follow-up.
Secondary Outcomes:
1. To evaluate the primary stability of both implant systems through a coefficient stability if implants using the Penguin RFA;
2. To evaluate the horizontal and vertical marginal bone loss via a CBCT, 1 year after implant placement;
3. To evaluate the soft tissues via the Pink Esthetic Score (PES) 1 year post-op.
Materials and Methods: Patients were randomly assigned in 2 groups of 15 patients, conical or inverta co-axis implants. Immediate implants in the aesthetic zone of the superior maxilar were placed with an immediate provisional crown restoration. In the same surgery, a connective tissue graft was performed. Only type I sockets according to the Elian Classification were eligible for this study.
Objectives:
Primary Outcomes: Evaluate the percentage of success and survival of the Inverted Co-Axis 12º Southern Implants versus the Internal Conical (Deep Tapered Conical) South Implants on a 1-2-1 follow-up.
Secondary Outcomes:
1. To evaluate the primary stability of both implant systems through a coefficient stability if implants using the Penguin RFA;
2. To evaluate the horizontal and vertical marginal bone loss via a CBCT, 1 year after implant placement;
3. To evaluate the soft tissues via the Pink Esthetic Score (PES) 1 year post-op.
Materials and Methods: Patients were randomly assigned in 2 groups of 15 patients, conical or inverta co-axis implants. Immediate implants in the aesthetic zone of the superior maxilar were placed with an immediate provisional crown restoration. In the same surgery, a connective tissue graft was performed. Only type I sockets according to the Elian Classification were eligible for this study.
Study Oversight
Has Oversight DMC:
False
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?: