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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Inverted Co-Axis 12º Southern Implants (15 patients): The implant is placed in the center of the socket due to that has an angled neck of 12º, which allows the implant to be placed in the center of the alveolus, optimizing the alveolar bone and improving the prosthetic emergence. This is due to the access of the screw being located palatally, simplifying the restoration of the crown, avoiding cemented crowns, lowering the laboratory cost and of prosthetic accessories. |
|
| Control Group | Active Comparator | Internal Conical (Deep Tapered Conical) South Implants (15 patients): conventional conical implant with internal connection. The implant is placed palatally in order to have a good emergence profile. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate Implant Surgery | Device | Inverted Co-Axis 12º Southern Implants |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Success Rate | ICOI Pisa Implant quality of Health Criteria | 1 year |
| Survival Rate | "the implant is still in mouth", | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Horizontal and Vertical bone Changes | Three CBCT will be made (CBCT 1- before implant placement, CBCT 2- just after implant placement, CBCT 3- 1 year before implant placement). First year bone loss overlap CBCT 1, 2 and 3. The horizontal bone changes will be from the implant platform at 1, 3 and 5mm from it. The vertical measurements will be from implant platform till the most vestibular and palatal bone peak. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Galve | Contact | +34659051487 | andreagalve@UIC.es | |
| Javier Gamon | Contact | +34627321249 | jgamon@uic.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitat Internacional de Catalunya | Recruiting | Sant Cugat del Vallès | Barcelona | 08195 | Spain |
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The patients will be randomized into two groups. The test group (n=15) will be treated with the Inverta Co-Axis 12º implant (Southern Implants). In the control group (n=15) the Internal Conical implants (Southern implants) will be used. The difference between both implants lies in the fact that the Inverta Co-Axis 12º implant presents two different variants to the classic implant with parallel walls (Internal Conical)
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| Immediate Implant Surgery |
| Device |
Internal Conical (Deep Tapered Conical) South Implants |
|
| 1 year |
| Implant primary stability | Recorded using Penguin RFA device | Right after the implant placement |
| Status of the soft tissues | The Pink Esthetic Score (PES) is based on seven variables: mesial papilla, distal papilla, soft tissue contour, gingival margin level, alveolar process deficiency, soft tissue colour and texture. Each variable will be evaluated with a score of 2-1-0, with 2 being the best score and 0 the worst score. The maximum score, which reflects a perfect coincidence of the peri-implant soft tissue with that of the reference tooth, is 14. | At 1 year |