Actively Recruiting
A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
Led by University of Sao Paulo · Updated on 2024-11-20
12
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants in patients who have experienced tooth loss. This observational prospective cohort study aims to determine if these drilling-free implants are safe, effective, and clinically viable over a 36-month period and whether they provide better post-operative outcomes compared to traditional implant methods. The study is conducted by the University of Sao Paulo. Participants in this study have received personalized dental implants using the iDENTICAL Dental Implant System immediately after tooth extraction during a previous interventional phase. This study follows a single group of twelve patients over 36 months, monitoring the implants at 12, 24, and 36 months after prosthesis installation. The focus is on assessing implant survival, peri-implant tissue health, post-operative comfort, bone preservation, and tissue integration. During the study, participants will undergo clinical and radiographic examinations at the specified time points to measure radiographic success, changes in peri-implant soft tissues, prosthetic outcomes, and other peri-implant clinical parameters. The study requires availability for follow-up visits throughout the 36-month observation period. Safety and efficacy data will be collected to understand the long-term outcomes of these customized dental implants.
CONDITIONS
Brief Title
A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 months
Participants who received a personalized dental implant are observed to evaluate the safety, efficacy, and clinical viability of the implants over time.
Follow-up visits at 12 months, 24 months, and 36 months
Trial Site Locations
Total: 1 location
1
School of Dentistry - University of São Paulo
São Paulo, Brazil, 05508-900
Actively Recruiting
Research Team
R
Romito
C
Cristina C Villar
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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