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

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

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 Overview

• Status: Withdrawn
• Conditions: Mouth, Edentulous
• Intervention / Treatment: Device: Full Dentures created by additive manufacturing

Detailed Description

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Northglenn, Colorado, United States, 80233
      • Affordable Dentures and Implants
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Wagner Denture Group 801 Encino Pl NE A3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dentsply International

Publications and helpful links

General Publications

• Celebic A, Knezovic-Zlataric D, Papic M, Carek V, Baucic I, Stipetic J. Factors related to patient satisfaction with complete denture therapy. J Gerontol A Biol Sci Med Sci. 2003 Oct;58(10):M948-53. doi: 10.1093/gerona/58.10.m948.
• Schwindling FS, Bomicke W, Hassel AJ, Rammelsberg P, Stober T. Randomized clinical evaluation of a light-cured base material for complete dentures. Clin Oral Investig. 2014;18(5):1457-65. doi: 10.1007/s00784-013-1110-4. Epub 2013 Sep 21.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2019
• Primary Completion (Anticipated): October 29, 2022
• Study Completion (Anticipated): October 29, 2022

Study Registration Dates

• First Submitted: June 21, 2019
• First Submitted That Met QC Criteria: June 24, 2019
• First Posted (Actual): June 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 17, 2022
• Last Update Submitted That Met QC Criteria: August 15, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Tooth Diseases; Mouth, Edentulous
• Other Study ID Numbers: PRPA2290/CR-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No