Recruiting

3D Printed & Milled Dentures

Sponsor:

Dentsply Sirona Implants and Consumables

Code:

NCT07586774

Conditions

Edentulous Mouth

Edentulous Jaw

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Lucitone Digital Print

Lucitone Digital Fit

Study Details

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).

Conditions

Edentulous Mouth

Edentulous Jaw

Study ID

NCT07586774

Start date

Sep 11, 2026

Status verified date

Sep, 2026

Completion date

Oct 30, 2032

Anticipated

Primary completion date

Oct 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 3D printed dentures

3D printed denture bases and 3D printed denture teeth.

experimental: Milled dentures

Milled denture bases and denture teeth.

Interventions

Lucitone Digital Print

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

Lucitone Digital Fit

Consisting of the following parts:

  • Lucitone Digital Fit Denture Discs.
  • Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.

Primary outcome measure

  • Denture survival rate [ Time Frame: One year after baseline (baseline = final denture insertion performed within 6-months from day 1) ]

Central Contacts and Locations

Central contacts

Ada Saltarski

+46 725568088ada.saltarski@dentsplysirona.com

Ulrika Bonander

+46 313763068ulrika.bonander@dentsplysirona.com

Locations

Adams School of Dentistry

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Sundass Kahn

919-537-3209sundass_kahn@med.unc.edu

More Information

Sponsor

Dentsply Sirona Implants and Consumables

Last update posted

Sep 17, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-18. This information was provided to ClinicalTrials.gov by Dentsply Sirona Implants and Consumables on 2026-09-17.