Dental Implant, Tooth Loss
Conditions
Brief summary
The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period. The main questions it aims to answer are: 1. Are these novel implants safe, effective, and clinically viable for 36 months? 2. Do these drilling-free implants result in better post-operative outcomes compared to traditional implant techniques? Twelve patients receiving these customized implants immediately after tooth extraction will undergo clinical and radiographic examinations at 12, 24, and 36 months after prosthesis installation. The study will assess peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.
Interventions
None listed
Sponsors
University of Sao Paulo
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Received a personalized dental implant using the iDENTICAL Dental Implant System during the previous interventional phase; * Completed the 12-month follow-up period after implant placement in the previous interventional phase; * Available for follow-up evaluations during the 36 months of the observational study.
Exclusion criteria
* Occurrence of serious complications (implant loss, infection, etc.) during the previous interventional phase; * Development of uncontrolled medical conditions during the follow-up period; * Inability to attend scheduled follow-up visits; * Refusal to participate in the observational study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic success | 12 months, 24 months and 36 months | Radiographic success, defined as the absence of peri-implant radiolucency and lack of progressive loss (\> 1.7 mm) of marginal bone level (MBL) over the 36 months following implant restoration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Linear horizontal changes of peri-implant soft tissues | 12 months, 24 months and 36 months | measured from intraoral scans at 1mm, 3mm, and 5mm below the reference gingival margin level at the time of crown placement, at 12, 24, and 36 months. |
| Prosthetic Level outomes | 12 months, 24 months and 36 months | Chipping/fracture of material; Loss of retention of restoration (cementation cement fracture); Connector (Abutment) fracture; Loss/failure of restoration substrate requiring new restoration; The restoration functions as intended/satisfactorily for the subject |
| Peri-implant clinical parameters | 12 months, 24 months and 36 months | Mobility (MOB) |
Countries
Brazil
Contacts
Primary ContactRomito
Backup ContactCristina C Villar
Outcome results
None listed