Clinical Outcomes of 3D Printed and Milled Complete Dentures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDentsply Sirona Implants and Consumables
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Lucitone Digital Print
- Lucitone Digital Fit
Treatment groups
68 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov