Clinical Outcomes of 3D Printed and Milled Complete Dentures
An Open, Single-center, Prospective, Randomized, Two-armed, Interventional, Post-market Clinical Investigation of 3D Printed Complete Dentures and Milled Complete Dentures During a 5-year Follow-up Period
1 other identifier
interventional
68
0 countries
N/A
Brief Summary
This is a two-armed, single-center clinical study evaluating performance, efficacy and safety of three dimensional (3D) printed complete dentures and milled complete dentures during a 5-year follow-up period. The primary objective of this clinical investigation is to evaluate survival rate, i.e. subjects with survived dentures in both upper and lower jaw, of 3D printed complete dentures and milled complete dentures after 1 year (in each of the groups separately).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2026
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2026
CompletedFirst Posted
Study publicly available on registry
May 14, 2026
CompletedStudy Start
First participant enrolled
May 30, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
Study Completion
Last participant's last visit for all outcomes
October 30, 2032
May 14, 2026
May 1, 2026
2.4 years
March 30, 2026
May 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Denture survival rate
Restorations still in function after 1 year.
One year after baseline (baseline = final denture insertion performed within 6-months from day 1)
Secondary Outcomes (19)
Denture survival rate
3 and 6 months, and 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture success
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture adaptation accuracy
At baseline (baseline = final denture insertion performed within 6-months from day 1)
Denture retention force
3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
Technical Complications
At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)
- +14 more secondary outcomes
Study Arms (2)
3D printed dentures
EXPERIMENTAL3D printed denture bases and 3D printed denture teeth.
Milled dentures
EXPERIMENTALMilled denture bases and denture teeth.
Interventions
Consisting of the following parts: * Lucitone Digital Print 3D Denture Base. * Lucitone Digital Interpenetrating Polymer Network (IPN) 3D Premium Tooth. * Lucitone Digital Print Denture System Accessories
Consisting of the following parts: * Lucitone Digital Fit Denture Discs. * Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2026
First Posted
May 14, 2026
Study Start (Estimated)
May 30, 2026
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
October 30, 2032
Last Updated
May 14, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share