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

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).

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.