A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Tooth Loss, Dental Implant. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Radiographic success [Time frame: 12 months, 24 months and 36 months]
Secondary outcome measures (3)
- Linear horizontal changes of peri-implant soft tissues [Time frame: 12 months, 24 months and 36 months]
- Prosthetic Level outomes [Time frame: 12 months, 24 months and 36 months]
- Peri-implant clinical parameters [Time frame: 12 months, 24 months and 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Brazil · 1 center
- School of Dentistry - University of São Paulo — São Paulo
Identifiers
NCT: NCT06576284 · 6.987.078