What is this study trying to find out about dental implants?

This study aims to evaluate the safety, effectiveness, and clinical viability of customized CAD/CAM dental implants over 36 months. Researchers want to know if these implants lead to better post-operative outcomes compared to traditional methods. It is led by the University of Sao Paulo and focuses on improving care for patients needing dental implants.

Who may be eligible for this dental implant clinical trial?

Adults who have received a personalized dental implant using the iDENTICAL system and completed 12 months of follow-up after implant placement may be eligible. Participants must be able to attend follow-up visits over 36 months and have no serious complications or uncontrolled medical conditions. Please review eligibility criteria for more details.

Is there any cost to participate in this dental implant clinical trial?

Study-related care, including all examinations and evaluations, is provided at no cost. However, personal travel and other expenses related to attending study visits may not be covered and can vary. Participants should plan accordingly for any travel they may need to do.

Actively Recruiting

All Genders

Healthy Volunteers

ID06576284

Evaluating the Safety and Effectiveness of Customized CADCAM Dental Implants Over 36 Months

Led by University of Sao Paulo · Updated on 2024-11-20

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the clinical performance of a new generation of customized CADCAM 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

All Genders

Healthy Volunteers

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

Research Team

Romito

Cristina C Villar

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