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

Recruiting

• Conditions: Dental Implant; Tooth Loss

• Registration Number: NCT06576284
• Lead Sponsor: University of Sao Paulo

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. 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

Not available

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-28
• Study Start: 2024-10-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Radiographic success	12 months, 24 months and 36 months	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.

Secondary Outcome Measures

Name	Time	Method
Peri-implant clinical parameters	12 months, 24 months and 36 months	Mobility (MOB)
Prosthetic Level outomes	12 months, 24 months and 36 months	Chipping/fracture of material; Loss of retention of restoration (cementation cement fracture); Connector (Abutment) fracture; Loss/failure of restoration substrate requiring new restoration; The restoration functions as intended/satisfactorily for the subject
Linear horizontal changes of peri-implant soft tissues	12 months, 24 months and 36 months	measured from intraoral scans at 1mm, 3mm, and 5mm below the reference gingival margin level at the time of crown placement, at 12, 24, and 36 months.

Trial Locations

Locations (1)

School of Dentistry - University of São Paulo; 🇧🇷 São Paulo, Brazil