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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized implant | This is an observational, prospective, single-cohort study conducted at the University of São Paulo, São Paulo, Brazil, involving individuals who received a personalized dental implant using the iDENTICAL Dental Implant System. The aim is to evaluate the safety, efficacy, and clinical viability of these customized implants over a 36-month follow-up period. |
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic success | 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. | 12 months, 24 months and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Linear horizontal changes of peri-implant soft tissues | 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. | 12 months, 24 months and 36 months |
| Prosthetic Level outomes |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals who received a personalized dental implant using the iDENTICAL Dental Implant System
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Romito | Contact | (11) 992051939 | +55 | garomito@usp.br |
| Cristina C Villar | Contact | (11)968403872 | +55 | villar@usp.br |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe A Romito, PhD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry - University of São Paulo | Recruiting | São Paulo | 05508-900 | Brazil |
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| ID | Term |
|---|---|
| D016388 | Tooth Loss |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014076 | Tooth Diseases |
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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 |
| 12 months, 24 months and 36 months |
| Peri-implant clinical parameters | Mobility (MOB) | 12 months, 24 months and 36 months |