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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Mouth, Edentulous

Intervention / Treatment
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* Device: Full Dentures created by additive manufacturing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Full Dentures created by additive manufacturing|Full dentures created by Additive manufacturing (Carbon Printers)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of the fit of the denture | Assessment of the fit of the new dentures in comparison to the previous prostheses in the mouth immediately after first insertion by dentist. A questionnaire of Assessment of fit by ranking from Much worse Worse Same Better Much better | 7 days after final placement of dentures | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetics of dentures | patients overall satisfactions of the dentures aesthetics. A questionnaire of assessment of fit by ranking from Much worse Worse Same Better Much better | 7 days after final placement of dentures | 
| Function of dentures | patients overall satisfaction of dentures to masticate. Assessment of fit by ranking from Much worse Worse Same Better Much better | 7 days after final placement of dentures | 
| Patient's satisfaction with denture and treatment | Patients are asked to compare existing and new denture by using a survey. a Questionnaire Assessment of fit by ranking from Much worse Worse Same Better Much better | 36 months after final placement | 
| Dentist's satisfaction with treatment | Assessment of treatment process in comparison to traditional denture fabrication process. A questionnaire Assessment of fit by ranking from Much worse Worse Same Better Much better | 7 Days after final placement | 
| Health of oral cavity and related tissues | Continuously clinical intra-oral inspection of oral landmarks and tissues with regard to any findings. ** *parameters according to Grandmont, ** Scottish Dental effectiveness program. Assessment of by scoring: pigmented ulcus white red swelling negative | 36 months after final placement |