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
Dentsply Sirona Implants and Consumables
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).
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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. Exclu…
Interventions
- DeviceLucitone 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
- DeviceLucitone Digital Fit
Consisting of the following parts: * Lucitone Digital Fit Denture Discs. * Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.
Location
- Adams School of DentistryChapel Hill, North Carolina