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

Withdrawn before enrolling

Conditions studied: Mouth, Edentulous

In brief

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.

Key facts

Study ID

NCT03997604

Run by

Dentsply International

People needed

0

Starts

2019-05-29

Expected to finish

2022-10-29

Last updated by the study team

2022-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 18 years or older.
• Subject has given written consent to participate in the trial.
• Subject is in good general health.
• Subject requires a new removable full denture for both jaws.
• Subject is completely edentulous in the maxilla and mandible.
• Subject is already wearing a full denture in the maxilla and mandible.
• Subject is willing to undergo dental treatment to receive a new full denture for both jaws.
• Subject confirms availability for treatment and all indicated follow-up visits.

You may not qualify if…

• Subject is younger than 18 years.
• Subject is pregnant.
• Subject has disabilities that do not allow a regular dental treatment.
• Subject with some systemic medical complications that cause difficulty in impression taking or judging occlusion of device.
• Subject is currently participating in another study.
• Subject has an allergic history regarding materials used in this trial.
• Subject with xerostomia/ dry-mouth syndrome.
• Lack of compliance is expected.
• Those subjects who cannot provide informed consent for any reason
• Acute stomatitis.
• Status after tumor treatment in head-neck region (removal, radiotherapy).
• Acute cancer.
• Incomplete hard and/or sift tissue in the oral cavity.
• Muscle and/or nerve damage in the head-neck region.
• Insufficient vertical height and/or insufficient mouth opening.
• Resilient hyperplastic mucosa ("flappy ridges").
• Bruxism.
• Insufficient oral hygiene. The existing dentures should have no visible calculus.
• Previously enrolled in the present investigation.
• Involvement in the planning and conduct of the clinical investigation. (applies to all Dentsply Sirona \& Carbon 3D staff, investigational site staff/Affordable staff and third party vendor).

Where it is running

• Affordable Dentures and Implants — Northglenn, Colorado, United States
• Wagner Denture Group 801 Encino Pl NE A3 — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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