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

Exclusion Criteria

• •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).