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

Study Overview
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Brief Summary
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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
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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 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.

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

Conditions
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Mouth, Edentulous

Intervention / Treatment
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* Device: Removable prostheses


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 soft 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 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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Edentulous Patients<br>The investigational device is part of a treatment concept for edentulous patients of all ages, gender and races. The incidence for tooth loss has not declined over years, and the prevalence for edentulism is significantly higher for adults 50 years and older. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of five (5) patients will be enrolled, i.e. 10 dentures will be fabricated within this study. | Device: Removable prostheses<br>* Full dentures created by Additive manufacturing (Carbon Printers)<br>* Other names: Lucitone 3D print resin dentures;|

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 | A questionnaire of assessment of fit by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1) | At Final Placement of Denture, through study completion, an average of one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aesthetics of dentures | A questionnaire of assessment of aesthetics by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1) | At Final Placement of Denture,through study completion, an average of one month | 
| Function of dentures | A questionnaire of assessment of function by ranking, in comparison to the previous denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1) | At Final Placement of Denture,through study completion, an average of 1 month | 
| Dentist's satisfaction with treatment: questionnaire | A questionnaire of assessment of satisfactions of treatment by ranking, in comparison to the previous placed denture, using a Likert Scale from a minimum of 5 to a maximum of 1. Much worse (5) Worse (4) Same (3) Better (2) Much better (1) | At Final Placement of Denture, through study completion, an average of 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Denture