Study Stopped
The Dental service organization that the Sponsor was working with did not meet the Sponsor's internal requirements for performing the clinical trial. As a result the study was withdrawn without any participant enrollment.
A Descriptive, Prospective Clinical Study to Evaluate Full Dentures Fabricated by Additive Manufacturing
1 other identifier
observational
N/A
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2019
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2019
CompletedFirst Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 29, 2022
CompletedAugust 17, 2022
August 1, 2022
3.4 years
June 21, 2019
August 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Aesthetics of dentures
7 days after final placement of dentures
Function of dentures
7 days after final placement of dentures
Patient's satisfaction with denture and treatment
36 months after final placement
Dentist's satisfaction with treatment
7 Days after final placement
Health of oral cavity and related tissues
36 months after final placement
Interventions
Full dentures created by Additive manufacturing (Carbon Printers)
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Affordable Dentures and Implants
Northglenn, Colorado, 80233, United States
Wagner Denture Group 801 Encino Pl NE A3
Albuquerque, New Mexico, 87102, United States
Related Publications (2)
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.
PMID: 14570864BACKGROUNDSchwindling 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.
PMID: 24057919BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 25, 2019
Study Start
May 29, 2019
Primary Completion
October 29, 2022
Study Completion
October 29, 2022
Last Updated
August 17, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share