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

NCT ID: NCT06576284

Last Updated: 2024-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-02

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tooth Loss Dental Implant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Personalized implant

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Giuseppe Alexandre Romito

Vice Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe A Romito, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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School of Dentistry - University of São Paulo

São Paulo, , Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Romito

Role: CONTACT

(11) 992051939 ext. +55

Cristina C Villar

Role: CONTACT

(11)968403872 ext. +55

Facility Contacts

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Giuseppe A Romito, PhD

Role: primary

+55 11 30917833

Marilia Gomes

Role: backup

+55 11 30917833

Other Identifiers

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6.987.078

Identifier Type: -

Identifier Source: org_study_id

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