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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 25, 2019
Last Update Posted Date June 25, 2019
Actual Study Start Date May 29, 2019
Estimated Primary Completion Date October 29, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 24, 2019)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Descriptive, Prospective Clinical Study to Evaluate Full Dentures Fabricated by Additive Manufacturing
Official Title A Descriptive, Prospective Clinical Study to Evaluate Fit and Quality of Full Dentures Fabricated by Additive Manufacturing
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Mouth, Edentulous
Intervention Device: Full Dentures created by additive manufacturing
Full dentures created by Additive manufacturing (Carbon Printers)
Other Name: Lucitone 3D print resin dentures
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 24, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 29, 2022
Estimated Primary Completion Date October 29, 2022   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: KATHLEEN A CATANZARO 609-845-8457 kathleen.catanzaro@dentsplysirona.com
Contact: Marilyn Goulding 717-767-8500 marilyn.goulding@dentsplysirona.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03997604
Other Study ID Numbers PRPA2290/CR-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Dentsply International
Study Sponsor Dentsply International
Collaborators Not Provided
Investigators Not Provided
PRS Account Dentsply International
Verification Date June 2019