3D-printed versus milled complete dentures in adults who are fully denture dependent

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-arm, single-center study comparing 3D-printed complete dentures to milled complete dentures in adults with complete edentulism. Participants will wear either 3D-printed Lucitone Digital Print or milled Lucitone Digital Fit dentures and be followed for five years to assess denture survival, function, and safety. The primary goal is to determine the one-year survival rate of each denture type in the upper and lower jaws. Outcomes will include denture retention, comfort, and any adverse events related to the materials or fabrication method. The study is conducted at a single site with a requirement for long-term follow-up visits.

Why it matters

Who can join: the full rules

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.

Where it's running

• Adams School of Dentistry
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Ada Saltarski
• Email: ada.saltarski@dentsplysirona.com
• Phone: +46 725568088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.