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Clinical Outcomes of 3D Printed and Milled Complete Dentures

NCT07586774 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-05-14

No results posted yet for this study

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).

Conditions

  • Edentulous Mouth
  • Edentulous Jaw

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.

Sponsors & Collaborators

  • Dentsply Sirona Implants and Consumables

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2028-10-30
Completion
2032-10-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07586774 on ClinicalTrials.gov