A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study

University of Sao Paulo

Status: Enrolling

Conditions: Tooth Loss; Dental Implant

Study type: Observational

Funder types: Other

Identifiers

NCT06576284

6.987.078

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

12 participants in 1 patient group

Personalized implant

Description:

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.