An observational study in Mouth, Edentulous, sponsored by Dentsply International. Withdrawn at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-17.
Sponsored by Dentsply International · Observational
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:
244 studies on the registry are indexed under Mouth, Edentulous; 37 are open to participants now.
Browse Mouth, Edentulous studies →Dentsply International is the lead sponsor of 10 studies on the registry; none are open to participants now.
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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 older15, 16. For this descriptive two-part survey, no minimum number of patients is defined, but to achieve a reasonable subject number, a minimum of forty (40) patients will be enrolled, i.e. 80 dentures will be fabricated within this study.
Exclusion Criteria:
Full dentures created by Additive manufacturing (Carbon Printers)
Also known as: Lucitone 3D print resin dentures
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
Time frame: 7 days after final placement of dentures
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 36 months after final placement
Plan to share: No
This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Dentsply International