Evaluation of customized dental implants over three years
A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
This study is testing how well personalized dental implants work for patients over three years compared to regular implants, looking at things like comfort and how well they last.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 12 (estimated) |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT06576284 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to assess the clinical performance of individualized CAD/CAM-produced dental implants over a 36-month period. It will evaluate the safety, effectiveness, and clinical viability of these novel implants compared to traditional techniques. Twelve patients who received these customized implants will undergo clinical and radiographic examinations at 12, 24, and 36 months post-prosthesis installation, focusing on peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.
Who should consider this trial
Good fit: Ideal candidates are individuals who have received a personalized dental implant using the iDENTICAL Dental Implant System and completed the 12-month follow-up after placement.
Not a fit: Patients who experienced serious complications during the previous interventional phase or have uncontrolled medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved outcomes and comfort for patients receiving dental implants.
How similar studies have performed: While this approach is innovative, similar studies evaluating customized dental implants have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
São Paulo
- School of Dentistry - University of São Paulo — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Giuseppe A Romito, PhD — University of Sao Paulo
- Study coordinator: Romito
- Email: garomito@usp.br
- Phone: (11) 992051939
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.