NCT04023006

An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures Fabricated by AM

An Observational Clinical Case Series Study to Assess Fit and Quality of Full Dentures

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 10 (actual)
• Sponsor: Dentsply International · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This observational clinical case series investigation will be conducted on approximately five (5) enrolled subjects at one (1) site in the US. Treatment of subjects encompasses all steps to fabricate new dentures for maxilla and/or mandible. The subjects will be followed 7-10 days after final delivery of the denture

Detailed description

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 AM (M 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 evaluation includes a patient survey to assess current dentures and the new AM dentures with a subjective comparison of both. The target subjects are male or female, 18 years and older with the need of a full denture in one or both jaws, being completely edentulous. The newly fabricated denture is to replace an existing full denture. For this descriptive study, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) and a maximum of ten (10) patients will be enrolled, i.e. ten to twenty (10-20) denture arches will be fabricated within this study.

Conditions

• Mouth, Edentulous

Interventions

Type	Name	Description
DEVICE	Removable prostheses	Full dentures created by Additive manufacturing (Carbon Printers)

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-04-01
• Completion: 2020-04-01
• First posted: 2019-07-17
• Last updated: 2021-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study