A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Sao Paulo
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Individuals who received a personalized dental implant using the iDENTICAL Dental Implant System
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
12 Participants
are grouped into 1 trial groupGroup A: Personalized implant
Trial outcomes
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.
Time frame
12 months, 24 months and 36 monthsSecondary outcomes
1
Linear horizontal changes of peri-implant soft tissues
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.
Time frame
12 months, 24 months and 36 months2
Prosthetic Level outomes
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
Time frame
12 months, 24 months and 36 months3
Peri-implant clinical parameters
Mobility (MOB)
Time frame
12 months, 24 months and 36 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov