Clinical Outcomes of 3D Printed and Milled Complete Dentures
Dentsply Sirona Implants and Consumables · NCT07586774
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 68
- US sites recruiting
- 1
- Study start
- September 11, 2026
- Record last updated
- September 17, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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).
Being studied: Lucitone Digital Print; Lucitone Digital Fit
Conditions: Edentulous Mouth; Edentulous Jaw
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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 Criteria
- 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.
Recruiting US locations
Adams School of Dentistry
Chapel Hill, NC 27599
Site contact: Sundass Kahn · 919-537-3209 · sundass_kahn@med.unc.edu
Study contacts (from the official record)
- Ada Saltarski · +46 725568088 · ada.saltarski@dentsplysirona.com
- Ulrika Bonander · +46 313763068 · ulrika.bonander@dentsplysirona.com