NCT03997604

A Descriptive, Prospective Clinical Study to Evaluate Full Dentures Fabricated by Additive Manufacturing

A Descriptive, Prospective Clinical Study to Evaluate Fit and Quality of Full Dentures Fabricated by Additive Manufacturing

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Dentsply International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This investigation is undertaken to evaluate the workflow and concomitant products to create full dentures by using Additive Manufacturing (AM) technology, i.e. Digital Light Processing™ Technology (Carbon 3D) to restore fully edentulous jaws. The assessment includes quality of materials provided by Dentsply Sirona Lab by using printers for Additive Manufacturing (M2 series, Carbon 3D 1089 Mills Way, Redwood City, CA 94063). This assessment will be done by clinical review of the AM dentures on fit and quality. In addition, the trial includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both.

Detailed description

Study Design: * This descriptive, prospective, clinical investigation will be conducted on approximately forty (40) enrolled subjects at four (4) sites in the US. * Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and mandible (no greater than five (5) visits; 30-60 min. chair time per appointment). * The subjects will be followed 7-10 days after final delivery of the denture for function check. * Long-term follow-up will be performed after 6 months, 12 months, 24 months and 36 months to assess fit, function, and esthetics under function performed by the dental professional and by capturing according feedback by the patient.

Conditions

• Mouth, Edentulous

Interventions

Type	Name	Description
DEVICE	Full Dentures created by additive manufacturing	Full dentures created by Additive manufacturing (Carbon Printers)

Timeline

• Start date: 2019-05-29
• Primary completion: 2022-10-29
• Completion: 2022-10-29
• First posted: 2019-06-25
• Last updated: 2022-08-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study