Clinical Outcomes of 3D Printed and Milled Complete Dentures

Official title

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

Overview

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).

Interventions

• Device 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
• Device Lucitone Digital Fit
  Consisting of the following parts: * Lucitone Digital Fit Denture Discs. * Dentsply Sirona Multilayer Polymethyl Methacrylate (PMMA) Discs.

Primary outcome measures

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

Secondary outcome measures (12)

• Denture survival rate [Time frame: 3 and 6 months, and 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Denture success [Time frame: 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Denture adaptation accuracy [Time frame: At baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Denture retention force [Time frame: 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Technical Complications [Time frame: At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Biological Complications [Time frame: At baseline, 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• OHIP-EDENT Questionnaire. [Time frame: 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Patient Satisfaction [Time frame: 3 and 6 months, and 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Denture quality assessed via volumetric loss [Time frame: At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Denture quality assessed via maximum vertical loss. [Time frame: At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Denture quality assessed by discolouration (delta E) at a central incisor (#8). [Time frame: At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]
• Denture quality assessed by occlusion (bite position). [Time frame: At baseline and 3 and 6 months, 1, 2, 3, 4 and 5 years after baseline (baseline = final denture insertion performed within 6-months from day 1)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Adams School of Dentistry — Chapel Hill

Identifiers

NCT: NCT07586774 · C-LA-24-020

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗