NCT07586774
Clinical Outcomes of 3D Printed and Milled Complete Dentures
Not Yet Recruiting
NAAges 18+InterventionalSupportive careDentsply Sirona Implants and Consumables
~68 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Lucitone Digital PrintLucitone Digital Fit
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Denture survival rate
Measured over One year after baseline (baseline = final denture insertion performed within 6-months from day 1)
Conditions
Where it's being run
1 sites across 1 statesNorth Carolina1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Adult aged 18 years or above at time of informed consent.
Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation.
Subject willing to comply with investigational related procedures and to return for follow-up visits for a period of 5 years.
Subject has signed and dated the informed consent form.
Subjects in need of complete dentures in maxilla and mandible.
Prosthodontic Diagnostic Index (PDI) Completely edentulous classification (Class 1-3).
History of edentulism of at least 1 year.
Exclusion
Known allergy or hypersensitivity to any of the components.
Subjects with significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6 ).
Known pregnancy at time of enrolment.
Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator.
Previous enrolment in the present clinical investigation.
Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site).
PDI Completely edentulous classification (Class 4)
Presence of severely atrophied ridge.
Presence of severe ridge undercuts.
Clinically severe Xerostomia.
Absence of hard or soft tissue pathology that precludes denture therapy.
Maxillofacial defects.
Uncontrolled pathological process in the oral cavity, as judged by the Investigator.
Participation in another clinical investigation that may interfere with the present clinical investigation.
What this trial measures
- Denture survival rateOne year after baseline (baseline = final denture insertion performed within 6-months from day 1)
Restorations still in function after 1 year.