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Mouth, EdentulousNCT03997604

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

An observational study of Mouth, Edentulous, run by Dentsply International at 2 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mouth, Edentulous
What is being tested?
Full Dentures created by additive manufacturing
Type of treatment
Medical device
How many people
0 participants
Where
2 sitesUnited States
Study dates
29 May 2019to 29 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Wagner Denture Group 801 Encino Pl NE A3

    Albuquerque, New Mexico, 87102

  • Affordable Dentures and Implants

    Northglenn, Colorado, 80233

Other trials in United States

About this study

Official title: 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.

Read the 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.
Being tested
Full Dentures created by additive manufacturing
Medical subject headings
Mouth, Edentulous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full Dentures created by additive manufacturingDevice

    Also called Lucitone 3D print resin dentures

    Full dentures created by Additive manufacturing (Carbon Printers)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 7 days after final placement of dentures

Secondary outcomes (5)

  1. 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

    Measured: 7 days after final placement of dentures

  2. Function of dentures

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

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

    Measured: 7 days after final placement of dentures

  3. 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

    Measured: 36 months after final placement

  4. 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

    Measured: 7 Days after final placement

  5. 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

    Measured: 36 months after final placement

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2019
  2. Study start29 May 2019
  3. Primary completion29 Oct 2022 (estimated)
  4. Study completion29 Oct 2022 (estimated)

Why it 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03997604
Sponsor's protocol ID
PRPA2290/CR-01
Status last verified
Aug 2022
First submitted
21 Jun 2019
Last updated
17 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 14570864

  • 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.

    PubMed 24057919

Questions about this trial

What is this clinical trial studying?

An observational study of Mouth, Edentulous, run by Dentsply International at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assessment of the fit of the denture (time frame: 7 days after final placement of dentures). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03997604, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2022.

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