Clinical Outcomes of 3D Printed and Milled Complete Dentures

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
Dentsply Sirona Implants and Consumables
Study ID
NCT07586774
Status
Not Yet Recruiting

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Conditions

  • Edentulous Jaw
  • Edentulous Mouth

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
May 30, 2026
Status verified
Jun 2026
Primary completion
Oct 30, 2028
Completion
Oct 30, 2032

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 3D printed dentures
    3D printed denture bases and 3D printed denture teeth.
  • Experimental: Milled dentures
    Milled denture bases and denture teeth.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIP
Adams School of DentistryChapel HillNorth Carolina27599

Find similar trials in Chapel Hill, NC

By research site
Adams School of Dentistry· Chapel Hill, NC

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