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

2019-07-01 05:25:16 | BioPortfolio


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.


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.

Study Design


Mouth, Edentulous


Full Dentures created by additive manufacturing


Affordable Dentures and Implants
United States




Dentsply International

Results (where available)

View Results


Published on BioPortfolio: 2019-07-01T05:25:16-0400

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Medical and Biotech [MESH] Definitions

The total absence of teeth from either the mandible or the maxilla, but not both. Total absence of teeth from both is MOUTH, EDENTULOUS. Partial absence of teeth in either is JAW, EDENTULOUS, PARTIALLY.

A chelating agent (CHELATING AGENTS) that sequesters a variety of polyvalent cations. It is used in pharmaceutical manufacturing and as a food additive.

Total lack of teeth through disease or extraction.

Procedure of producing an imprint or negative likeness of the teeth and/or edentulous areas. Impressions are made in plastic material which becomes hardened or set while in contact with the tissue. They are later filled with plaster of Paris or artificial stone to produce a facsimile of the oral structures present. Impressions may be made of a full complement of teeth, of areas where some teeth have been removed, or in a mouth from which all teeth have been extracted. (Illustrated Dictionary of Dentistry, 1982)

Either of the two fleshy, full-blooded margins of the mouth.

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Dentistry is the study, management and treatment of diseases and conditions affecting the mouth, jaw, teeth and their supporting tissues (Oxford Medical Dictionary) The work of a dentist ranges from regular patient check-up to orthodontics and surgery....

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