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: 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Inverted Co-Axis 12º Southern Implants
Internal Conical (Deep Tapered Conical) South Implants
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
RECRUITINGSuccess Rate
ICOI Pisa Implant quality of Health Criteria
Time frame: 1 year
Survival Rate
"the implant is still in mouth",
Time frame: 1 year
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.
Time frame: 1 year
Implant primary stability
Recorded using Penguin RFA device
Time frame: 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.
Time frame: At 1 year
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