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 range18 Years
SexALL
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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
✕. Presence of peri-implant mucositis or peri-implantitis at the time of evaluation.
✕. Implant mobility or implant positioning that prevents proper prosthetic rehabilitation.
✕. Uncontrolled systemic medical conditions that could interfere with study participation or prosthetic treatment.
What they're measuring
1
Multi-assessment global passive fit score of definitive full-arch implant-supported prostheses