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

NCT06576284 | Recruiting

• 1 other identifier: 6.987.078
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 1.Are these novel implants safe, effective, and clinically viable for 36 months?
2. 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.

Conditions

Tooth Loss; Dental Implant

Outcome Measures

Primary Outcomes (1)

• Radiographic success

  Radiographic success, defined as the absence of peri-implant radiolucency and lack of progressive loss (\> 1.7 mm) of marginal bone level (MBL) over the 36 months following implant restoration.

  12 months, 24 months and 36 months

Secondary Outcomes (3)

• Linear horizontal changes of peri-implant soft tissues

  12 months, 24 months and 36 months

• Prosthetic Level outomes

  12 months, 24 months and 36 months

• Peri-implant clinical parameters

  12 months, 24 months and 36 months

Study Arms (1)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Individuals who received a personalized dental implant using the iDENTICAL Dental Implant System

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

School of Dentistry - University of São Paulo

São Paulo, 05508-900, Brazil

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases

Study Officials

• Giuseppe A Romito, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Romito

CONTACT

(11) 992051939; garomito@usp.br

Cristina C Villar

CONTACT

(11)968403872; villar@usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Dean

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 28, 2024
• Study Start: October 2, 2024
• Primary Completion: October 1, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 20, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)