An observational study in Tooth Loss and Dental Implant, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by University of Sao Paulo · Observational
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:
165 studies on the registry are indexed under Tooth Loss; 44 are open to participants now.
This study's planned enrollment of 12 is below the median of 80 across 40 observational studies indexed under Tooth Loss.
Browse Tooth Loss studies →University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Individuals who received a personalized dental implant using the iDENTICAL Dental Implant System
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Time frame: 12 months, 24 months and 36 months
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.
Time frame: 12 months, 24 months and 36 months
Prosthetic Level outomes
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
Time frame: 12 months, 24 months and 36 months
Peri-implant clinical parameters
Mobility (MOB)
Time frame: 12 months, 24 months and 36 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2024 (actual). Primary completion is estimated for Oct 2025, 12 months after the start.
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