Passive Fit of Implant-Supported Complete-Arch Prostheses Using Digital Workflows (NCT07315620) | Clinical Trial Compass
RecruitingNot Applicable
Passive Fit of Implant-Supported Complete-Arch Prostheses Using Digital Workflows
Spain30 participantsStarted 2026-01-01
Plain-language summary
The goal of this clinical trial is to evaluate and compare three digital workflows for the fabrication of definitive implant-supported full-arch prostheses in adult patients requiring fixed implant rehabilitation.
The main questions it aims to answer are:
* Does an automated AI-assisted digital workflow improve the passive fit of definitive full-arch implant-supported prostheses compared with manual and splint-guided alignment workflows?
* Are there differences in marginal, geometric, mechanical, and radiographic passivity among the three digital workflows? Researchers will compare manual CBCT-STL alignment, splint-guided alignment, and automated AI-assisted CBCT-STL alignment to see if the degree of digital workflow automation affects the passive fit of definitive full-arch implant-supported prostheses.
Participants will:
* Be adults (18 years and older) indicated for fixed implant-supported full-arch rehabilitation.
* Receive a definitive, screw-retained, full-arch implant-supported prosthesis fabricated using one of the three assigned digital workflows.
* Undergo standardized clinical and radiographic assessments at the time of definitive prosthesis placement to evaluate prosthesis passive fit.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adults aged 18 years or older.
. Patients indicated for fixed implant-supported full-arch rehabilitation in the maxilla or mandible.
. Presence of clinically stable, osteointegrated titanium implants suitable for prosthetic rehabilitation.
. Absence of clinical or radiographic signs of peri-implant disease.
. Ability to understand the study procedures and provide written informed consent.
. Willingness and ability to attend all required clinical visits and evaluations.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Multi-assessment global passive fit score of definitive full-arch implant-supported prostheses