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

Last updated: November 18, 2024
Sponsor: University of Sao Paulo
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dental Filling

Periodontitis

Treatment

N/A

Clinical Study ID

NCT06576284
6.987.078
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Received a personalized dental implant using the iDENTICAL Dental Implant Systemduring the previous interventional phase;

  • Completed the 12-month follow-up period after implant placement in the previousinterventional phase;

  • Available for follow-up evaluations during the 36 months of the observational study.

Exclusion

Exclusion Criteria:

  • Occurrence of serious complications (implant loss, infection, etc.) during theprevious 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.

Study Design

Total Participants: 12
Study Start date:
October 02, 2024
Estimated Completion Date:
October 31, 2026

Connect with a study center

  • School of Dentistry - University of São Paulo

    São Paulo, 05508-900
    Brazil

    Active - Recruiting

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