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

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ClinicalTrials.gov Identifier: NCT03997604
Recruitment Status : Recruiting
First Posted : June 25, 2019
Last Update Posted : June 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dentsply International

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.

Condition or disease Intervention/treatment
Mouth, Edentulous 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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Descriptive, Prospective Clinical Study to Evaluate Fit and Quality of Full Dentures Fabricated by Additive Manufacturing
Actual Study Start Date : May 29, 2019
Estimated Primary Completion Date : October 29, 2022
Estimated Study Completion Date : October 29, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures


Intervention Details:
  • Device: Full Dentures created by additive manufacturing
    Full dentures created by Additive manufacturing (Carbon Printers)
    Other Name: Lucitone 3D print resin dentures


Primary Outcome Measures :
  1. assessment of the fit of the denture [ Time Frame: 7 days after final placement of dentures ]

    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


Secondary Outcome Measures :
  1. Aesthetics of dentures [ Time Frame: 7 days after final placement 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

  2. Function of dentures [ Time Frame: 7 days after final placement of dentures ]

    patients overall satisfaction of dentures to masticate. Assessment of fit by ranking from

    • Much worse
    • Worse
    • Same
    • Better
    • Much better

  3. Patient's satisfaction with denture and treatment [ Time Frame: 36 months after final placement ]

    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

  4. Dentist's satisfaction with treatment [ Time Frame: 7 Days after final placement ]

    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

  5. Health of oral cavity and related tissues [ Time Frame: 36 months after final placement ]

    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997604


Contacts
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Contact: KATHLEEN A CATANZARO 609-845-8457 kathleen.catanzaro@dentsplysirona.com
Contact: Marilyn Goulding 717-767-8500 marilyn.goulding@dentsplysirona.com

Locations
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United States, Colorado
Affordable Dentures and Implants Completed
Northglenn, Colorado, United States, 80233
United States, New Mexico
Wagner Denture Group 801 Encino Pl NE A3 Recruiting
Albuquerque, New Mexico, United States, 87102
Contact: Stephen Wagner, DDS CAGS    505-232-3588    bigjawbone@mac.com   
Contact: Jon Wagner, DDS    505-232-3588    bigjawbone@mac.com   
Sponsors and Collaborators
Dentsply International

Publications:
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Responsible Party: Dentsply International
ClinicalTrials.gov Identifier: NCT03997604     History of Changes
Other Study ID Numbers: PRPA2290/CR-01
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Mouth, Edentulous
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases